Home
Pre Filled Syringes East Coast
April 25 - April 26, 2022
Pre Filled Syringes East Coast

SAE Media Group’s 9th Annual Conference
Pre-Filled Syringes East Coast
April 25 - 26, 2022 | Boston, USA
-------------------------------------------------------------------------

The global pre-filled syringes market was valued at $1139.6 million in 2020 and with the rapid growth of the industry, is expected to grow at a CAGR of 8.95% up to 2027. With that in mind, the 9th annual Pre-Filled Syringes East Coast conference will bring together leading industry experts representing big pharma and device developers to discuss the key drivers accelerating the expansion of the industry.

The past year has seen significant developments in the injectables landscape with the rapid introduction and development of vaccines in response to the pandemic, updates in regulations including the EU MDR and FDA guidance on bridging studies, and increasing industry acceptance of connectivity to aid the user experience. As part of SAE Media Group’s leading injectable series, the 2022 conference will provide an exclusive insight into the latest developing technologies for device design, advances in parenteral device platforms and development, insights into growing integration of digital health and deep dives into recent case studies on novel delivery systems.

This two-day agenda offers you peer-to-peer networking with Global Product Managers, Senior PFS Engineers, Device Testing Managers, Heads of Late-Stage PFS Development and many more.

To register your interest or to get involved please contact: yalsadoon@SAE Media Group-online.co.uk

FEATURED SPEAKERS

Amber Witteman

Amber Witteman

Founding Director, Ebenroth B.V., EPiWatch
Amir Fakhari

Amir Fakhari

Associate Principal Engineer, Combination Products, AstraZeneca
Christine Lynn Lanning

Christine Lynn Lanning

Distinguished Scientist, Device Area Leader, Merck & Co., Inc
Daniele Tartini

Daniele Tartini

Business Development Manager for Glass Syringes, SCHOTT North America, Inc.
Deep S Bhattacharya

Deep S Bhattacharya

Senior Scientist, Pfizer
Derya Gulsen Onbilger

Derya Gulsen Onbilger

Technical Services Manager, BD
Gennevieve Douglas

Gennevieve Douglas

Associate Director, Global Regulatory Affairs Devices, Sanofi US
Gretchen  Vandal

Gretchen Vandal

Sr. Director, Head of Global Regulatory Affairs - Devices and Combination Products, Takeda
Gretchen Piwinski

Gretchen Piwinski

Manager, Combination Products Laboratories, Regeneron
Jason Song

Jason Song

CTO, SureMed Technologies, Inc.
John Barr Weiner

John Barr Weiner

Associate Director for Policy and Product Classification Officer, Food and Drug Administration
John Merhige

John Merhige

Chief Commercial Officer, Credence MedSystems
John Schalago

John Schalago

Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
Larry Atupem

Larry Atupem

Strategic Business Development Manager, Zeon Specialty Materials
Michael Song

Michael Song

Associate Director, Takeda Pharmaceutical Company Limited
Olga Laskina

Olga Laskina

Manager, Technical Product Development, West Pharmaceutical Services, Inc.
Theresa Jeary

Theresa Jeary

Technical Specialist & Scheme Manager, BSI
Theresa Scheuble

Theresa Scheuble

Head Enterprise Design & Innovation, Johnson & Johnson
Tieming Ruan

Tieming Ruan

Senior Director of Device Development, Alexion Pharmaceuticals

Amber Witteman

Founding Director, Ebenroth B.V., EPiWatch
Amber Witteman

Amber Wittman, Managing Director, EPIWatch, is an entrepreneur and inventor of the EPIWatch autoinjector. Ms Wittman is also responsible for the intellectual property landscape, device component developments and is continuously working on project prosperity.

Amir Fakhari

Associate Principal Engineer, Combination Products, AstraZeneca
Amir Fakhari

Amir Fakhari is a Senior Engineer in Global Technical Operations at AstraZeneca. He has more than ten years of experience with biological and pharmaceutical product development, life cycle management, combination products, and drug delivery systems. At AstraZeneca, Amir works on development, commercialization, and life cycle management of combination products. Prior to his current role, he has worked for Emergent BioSolutions, Lonza, and Teva Pharmaceuticals. He received his PhD in Bioengineering from University of Kansas.
 

Christine Lynn Lanning

Distinguished Scientist, Device Area Leader, Merck & Co., Inc
Christine Lynn Lanning

Dr. Christine Lynn Lanning is a Distinguished Scientist in Safety Assessment at Merck. In this role, she provides oversight of the biocompatibility of medical devices and medical device combination products. She has a PhD from Duke University in Pharmacology/Toxicology and is Six Sigma Green and Black Belt Certified. She has been at Merck over 20 years with experience with both drug and device development. She has authored over 200 scientific reports and over 50 regulatory submissions.

Daniele Tartini

Business Development Manager for Glass Syringes, SCHOTT North America, Inc.
Daniele Tartini

Daniele Tartini has a background in chemical engineering (degree from ETH Zurich). Daniele has 5 years experience in the primary packaging industry in different functions, from production to customer facing roles. Daniele has worked on many projects with pharmaceutical companies to develop the right PFS for the respective applications and has mainly focused on PFS for vaccines and biologics.

 

Deep S Bhattacharya

Senior Scientist, Pfizer
Deep S Bhattacharya

Deep S Bhattacharya is a senior scientist working with DPDD since November 2019. He received his Ph.D. from the University of Nebraska Medical Center, College of Pharmacy in Pharmaceutical Sciences with a focus in engineering polymer-protein conjugates and polymeric nanoparticles using computational chemistry, biophysical tools, formulation developments, to in vivo characterizations in multiple animal models. After joining Pfizer, he has worked with DMD gene therapy, CD80, p40-TL1A bispecific, and currently leading CpG/Alhydrogel adjuvant program for C.Diff and Tetra-Fab LTβR programs. He is experienced in the formulation development of recombinant protein vaccines and high concentration mAbs. His areas of interest include biophysical assessment of proteins, utilizing NMR for structural determination of biologics, subcutaneous assessments of biologics, early-stage development of biologics, interfacing with early-stage discovery teams for candidate selection, and understanding business strategies for developments of biopharmaceuticals. He also is involved group functions involving CPED DPDD and new colleague recruitments efforts with the St. Louis DPDD.

Derya Gulsen Onbilger

Technical Services Manager, BD
Derya Gulsen Onbilger

Derya Onbilger is the Technical Services Manager for Global and Strategic Accounts at BD Medical - Pharmaceutical systems. Prior to joining BD, she worked for Edgewell Personal Care and DuPont protection technologies in various R&D roles.

Derya holds a PhD in Chemical Engineering from University of Florida and MSc and BSc degrees from Middle East Technical University in Turkey.

Gennevieve Douglas

Associate Director, Global Regulatory Affairs Devices, Sanofi US
Gennevieve Douglas

Gennevieve Douglas is currently a Global Regulatory Affairs Device Lead for Specialty Care & Vaccine Combination Products, where she is responsible for global regulatory strategies, submissions, and approvals for drug-device combination products. She has over 9 years of industry experience as a global/device regulatory lead and device engineer for several device-drug combination products across various therapeutic areas. She has a B.S. in Biomedical Engineering from California Polytechnic State University, San Luis Obispo.

Gretchen Vandal

Sr. Director, Head of Global Regulatory Affairs - Devices and Combination Products, Takeda
Gretchen  Vandal

Gretchen Vandal is Head of Global Regulatory Affairs – Devices at Takeda. She has over 20 years of experience in the biopharma industry, supporting both drugs and devices. Her device regulatory expertise is in the area of digital technologies, including medical device software, clinical trial technology and drug development tools, digital biomarkers, and diagnostic algorithms. Prior to joining Takeda, Gretchen led the Global Regulatory Affairs Digital Health and Software Medical Devices team at Sanofi. Prior to Sanofi, Gretchen was in Global Regulatory Affairs at Biogen where she worked on combination products, SaMD, clinical trial technology, and companion diagnostics. Prior to Biogen, Gretchen was at Amgen where she held roles in both Quality and Global Regulatory Affairs. Gretchen holds a BS in Microbiology from the University of Rhode Island and a MS in Regulatory Affairs and an MBA, both from Northeastern University.

Gretchen Piwinski

Manager, Combination Products Laboratories, Regeneron
Gretchen Piwinski

Gretchen Piwinski is the Manager of the Combination Product Development Laboratory at Regeneron Pharmaceuticals Inc. She leads a team responsible for providing test engineering and laboratory support to the development of drug delivery systems for Regeneron’s products. Gretchen has been at Regeneron for four years and spent 12 years prior working on implantable medical devices. She holds a Bachelor of Science degree and a Master of Engineering degree, both in Chemical Engineering.

Jason Song

CTO, SureMed Technologies, Inc.
Jason Song

Jason Song is Chief Technology Officer and cofounder of SureMed Technologies, Inc. that develops holistic novel technologies and products to meet the needs of patients, industry and society for easy deployment. Prior to SureMed Tech, he held various technical and leadership positions at Amgen, Eli Lilly, GE Healthcare, Motorola and Novo Nordisk in areas including injectable & inhaled drug delivery device development, fill and finish, packaging and assembly automation, biochips, and establishing new production sites. Jason's experience includes in US, Europe and Asian. Jason is a certified licensed Professional Engineer (P.E.) and holds BS & MS in Mechanical Engineering, MS in Automation MFG, and MBA.

John Barr Weiner

Associate Director for Policy and Product Classification Officer, Food and Drug Administration
John Barr Weiner

John Weiner is the Associate Director for Policy in the Food and Drug Administration’s Office of Combination Products, which is tasked with the classification and assignment for regulation of therapeutic products (drugs, devices, biological products, and combination products), and with ensuring the sound and consistent regulation of combination products. Prior to joining OCP, Mr. Weiner was an Associate Chief Counsel in FDA’s Office of Chief Counsel, advising the agency on various issues including regulation of drugs and cross-cutting topics including the regulation of products that use nanotechnology. Before coming to FDA, Mr. Weiner was in private practice in the areas of food and drug, environmental, and related aspects of public international and trade law. He has published and lectured on topics in all three areas. Mr. Weiner received a B.A. from Princeton University and a J.D. with honors from the Columbia University School of Law.

John Merhige

Chief Commercial Officer, Credence MedSystems
John Merhige

John A. Merhige is Chief Commercial Officer at Credence MedSystems, leading the Company's commercial activities and external collaborations. Previously, John was Vice President, Market Development at Sanofi. He came to Sanofi upon its acquisition of Pluromed, which John joined in its early stages and where he was a member of the executive management team leading the Company’s sales and marketing efforts. Prior to Pluromed, John founded Prelude Devices to target early-stage medical device technologies for development and commercialization.

John Schalago

Executive Director, Senior Global Program Director Regulatory Affairs, Novartis
John Schalago

John is Regulatory/Quality/Clinical professional with over 30 years of experience in research & development, quality assurance/control, clinical affairs, regulatory affairs and executive management. John has extensive experience with global health authorities as well as with CDRH, CBER, and CDER managing submission strategies, HA interactions and submissions. John has a diverse background which includes expertise in combination products, software-controlled medical device submissions including, sensors (implantable, minimally invasive and in-vitro diagnostics, and software as a medical device, including, mobile applications and web-based clinical decision software.

 

Larry Atupem

Strategic Business Development Manager, Zeon Specialty Materials
Larry Atupem

Larry Atupem is the Business Development Manager at Zeon Specialty materials with responsibility of Cyclic Olefin Polymer business in North America. He also assists with ZEON’s strategic interests in the region looking for new opportunities in the diagnostic space. He has over decade of experience in multiple industries spanning from pharmaceutical science, thermal packaging, and thermoplastics. He holds a Bachelor of Science degree in Chemical & Biological Engineering from Tufts University.

Michael Song

Associate Director, Takeda Pharmaceutical Company Limited
Michael Song

Michael currently is Associate Director of Device Development at Takeda. Prior to his current role he was head of Combination Product Manufacturing at Heron Therapeutics where he led medical device and combination product commercial readiness. Prior to Heron, he formed and led the Device Functionality, Safety and Digital Connectivity group at AstraZeneca where his group oversaw device functionality portion of device development; primary container science and technology; biocompatibility; container closure integrity programs; and digital connectivity. Prior to AstraZeneca, he was head of Device, Package, and Process Engineering at Adello Biologics, a member of Amneal Pharmaceutical. He also has held key engineering lead and toxicology SME positions at Stryker, Kavlico, and other companies. Michael holds a BS in Electrical Engineering from Purdue University and PhD in Neuroscience and Toxicology from Iowa State University.

Olga Laskina

Manager, Technical Product Development, West Pharmaceutical Services, Inc.
Olga Laskina

Dr. Olga Laskina is a Technical Product Development Manager at West Pharmaceutical Services. She supports new product development at West and is responsible for external publications on new products. She has comprehensive knowledge of regulatory requirements on container closure integrity, functionality, extractables and leachables, and particle limits. Prior to joining West Pharmaceutical Services, she developed new approaches and methodologies for analysis of particulates in pharmaceutical products at rap.ID. She earned her PhD in Chemistry from the University of Iowa with focus on chemical and physical properties of microparticles and contributed to more than 20 publications.

Theresa Jeary

Technical Specialist & Scheme Manager, BSI
Theresa Jeary

Theresa Jeary has over 30 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle. She holds a master’s degree in Pharmaceutical Science from the Royal College of Surgeons, Ireland and is eligible to be a Pharmaceutical Qualified Person.

Additionally, Theresa has over 12 years Notified Body experience, at BSI as a technical expert and LRQA as the Head of Notified Body. Before re-joining BSI as a technical specialist in the Medicinal and Biologics team, Theresa worked as a consultant to the Medtech sector.
 

Theresa Scheuble

Head Enterprise Design & Innovation, Johnson & Johnson
Theresa Scheuble

Theresa Scheuble is a Head of Enterprise Design & Innovation for Johnson & Johnson. She is an expert on combination product requirements and considerations supporting all segments of Johnson & Johnson.

Prior to her current role, she was Head of the Combination Product Drug Delivery Systems Development for the East Coast team in Janssen, a Johnson & Johnson Company. While at Janssen, Theresa was responsible for Combination Product Device development and led cross-sector initiatives.

Theresa has been with Johnson & Johnson for 26 years, working in all Segments of Johnson & Johnson with 18 years specifically in the Medical Device Segment. She was the project lead and technical lead for greater than 20 portfolio enhancing products by Johnson & Johnson companies. She also has experience in the Automotive and Aerospace industries.
 

Tieming Ruan

Senior Director of Device Development, Alexion Pharmaceuticals
Tieming Ruan

Tieming holds his PhD in Mechanical Engineering from the Ohio State University and MBA from New York University. Currently he is Sr. Director of Combination Products at Alexion Pharmaceuticals. He has been working for various biotech and medical device companies in the past 18 years and hold 10+ patents of drug delivery devices.

sponsors

Conference agenda

clock

8:00

Registration & Coffee

clock

9:00

Chair's Opening Remarks

Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs - Devices and Combination Products, Takeda

clock

9:10

Approaches and considerations to building an efficient and de-risk combination product development program

Michael Song, Associate Director, Takeda Pharmaceutical Company Limited

  • Cross functional interconnection and ways to ensure program success
  • EU MDR GSPR and leveraging from program success
  • Understanding essential performance requirement
  • How an effective control strategy can help ensure program success
  • Design control and risk reduction activities
  • clock

    9:50

    Lessons learned: on-body delivery system design and development

    Amber Witteman, Founding Director, Ebenroth B.V., EPiWatch

  • Learning from user experiences in early development of delivery systems
  • Current regulatory guidance for wearable devices and understanding international requirements
  • Case Study: designing patient-centric on-body delivery systems
  • How have we seen device design evolving in recent years and a future forecast
  • clock

    10:15

    Morning Coffee Sponsored by Zeon

    clock

    10:45

    Improvement of complaint intake process for combination products: a patient centric approach

    Amir Fakhari, Associate Principal Engineer, Combination Products, AstraZeneca

  • Overview of complaint intake process and current limitations for complaint analysis
  • Harmonization, accuracy, and time reduction for complaint analysis
  • clock

    11:25

    Selecting drug delivery systems for higher dose volume and higher viscosities

    Derya Gulsen Onbilger, Technical Services Manager, BD

  • High dose biologic formulations are pushing drug volume and viscosity beyond traditional self-injection design space limits (> 15 cP, > 1 ml dose volume), which can challenge patients’ capabilities to administer their injections based on injection time or force.
  • We will discuss how ergonomic, manual, syringe-based injections can enable subcutaneous self-injections with characteristics that go beyond the traditional boundaries of volume and viscosity.
  • Important factors for development of combination products involving delivery of higher volumes (1-2 mL) are presented, including assembly, human factors, documentation, and platform considerations.
     
  • clock

    12:05

    A Glass Alternative: ZEONEX® and ZEONOR® Cyclo Olefin Polymer (COP) for Pre-Filled syringes

    Larry Atupem, Strategic Business Development Manager, Zeon Specialty Materials

  • Key Benefits of COP for Medical Devices 
  • Case Study on Delamination: COP Syringe vs Glass Syringe
  • Case Study on Protein Adsorption/Aggregation and its effect on Immunogenicity

     

  • clock

    12:45

    Networking Lunch

    clock

    13:45

    Panel Discussion: Learnings from the past year to accelerate combination product development

  • Assessing regulatory developments for combination products over the past year 
  • Emerging device design innovations for parenteral delivery
  • Assessing the landscape of connected technology applications, how can we ensure smart features are aiding the user?
  • Encouraging flexibility and collaborations throughout the combination product development process across all teams
  • Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs - Devices and Combination Products, Takeda

    Amir Fakhari, Associate Principal Engineer, Combination Products, AstraZeneca

    Gretchen Piwinski, Manager, Combination Products Laboratories, Regeneron

    John Schalago, Executive Director, Senior Global Program Director Regulatory Affairs, Novartis

    Christine Lynn Lanning, Distinguished Scientist, Device Area Leader, Merck & Co., Inc

    clock

    14:25

    The Value of Collaboration to Advance Innovation in Drug Delivery Technology

    John Merhige, Chief Commercial Officer, Credence MedSystems

  • The challenges of innovation in the pharmaceutical industry
  • How to fit innovation into an existing supply chain
  • Leveraging the power and validation that comes from collaborating with leading partners
  • Making sure strategic partnerships are in fact strategic
  • clock

    15:05

    Combination Product Verification and Validation: Leveraging Data for Regulatory Submissions

    Theresa Scheuble, Head Enterprise Design & Innovation, Johnson & Johnson

  • Discussion of how verification and validation data can be bridged from one product to another, review of FDA Guidance
  • Examples of successful human factors validation data leveraging
  • Review of current thinking on Essential Performance Requirements for combination products submitted to FDA
  • clock

    15:45

    Afternoon Tea Sponsored by Zeon

    clock

    16:15

    Considerations for Designing Test Method Validation Studies

    Gretchen Piwinski, Manager, Combination Products Laboratories, Regeneron

  • Identification of critical variables affecting test output
  • Establishing test limits and acceptance criteria
  • Understanding the manufacturing process for sample parts
  • Special considerations for destructive testing
  • clock

    16:55

    Leveraging supplier information for pre-filled syringe development

    Christine Lynn Lanning, Distinguished Scientist, Device Area Leader, Merck & Co., Inc

  • Biocompatibility basics in drug delivery device development
  • Engaging in supplier information in drug delivery development
  • Assessing ISO 10993 and the phased approach 
  • Understanding materials safety concerns and the critical questions to ask suppliers
  • clock

    17:35

    Chair’s Closing Remarks

    Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs - Devices and Combination Products, Takeda

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs - Devices and Combination Products, Takeda

    clock

    9:10

    An update on FDA regulatory guidance from the office of combination products

    John Barr Weiner, Associate Director for Policy and Product Classification Officer, Food and Drug Administration

  • Summary of recently issued premarket and postmarket policies for combination products, and status of pending policy projects, including on such topics as:
  • Essential performance requirements
  • Human factors studies and related clinical study considerations
  • Principles of premarket pathways for combination products
  • Post market safety reporting
  • Facility inspections
  • Looking to the future, how can we expect the regulatory landscape to evolve for combination products, and opportunities to promote cross-jurisdiction collaboration and convergence
  • clock

    9:50

    EPR and Control Strategy of Prefilled Syringe

    Tieming Ruan, Senior Director of Device Development, Alexion Pharmaceuticals

  • Discuss the latest EPR feedback of a Prefilled Syringe 
  • Discuss the control strategy practice of a prefilled syringe
  • Discuss a case study of prefilled syringe control strategy
  • clock

    10:30

    Morning Coffee Sponsored by Zeon

    clock

    11:00

    Regulatory Considerations for Combination Product Lifecycle Management

    Gennevieve Douglas, Associate Director, Global Regulatory Affairs Devices, Sanofi US

  • An overview of the current regulatory requirements for change management
  • Best practices for assessing device changes and use of ISO 20069, Guidance for assessment and evaluation of changes to drug delivery systems
  • Considerations for defining reporting categories for device changes
  • Submission considerations and utilization of regulatory tools, including ICH Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
  • clock

    11:40

    USP <382> and characterization of plunger functional suitability in parenteral packaging

    Olga Laskina, Manager, Technical Product Development, West Pharmaceutical Services, Inc.

  • An overview of the new USP <382> chapter, effective in 2025, with fitness for intended use functional suitability tests and requirements.
  • Industry leading plunger components were evaluated and results to be presented to demonstrate characterization in line with USP <382>.
  • Considerations for laboratories that will offer testing services according to the new USP <382>
  • clock

    12:20

    EU MDR Article 117: Notified Body update on the quality of submissions and lessons learnt

    Theresa Jeary, Technical Specialist & Scheme Manager, BSI

  • Recap of requirements and products impacted
  • Update on NB experience of process and submissions
  • Common gaps in applications
  • Available Guidance
  • clock

    13:00

    Networking Lunch

    clock

    14:00

    Cold Temperature Performance of Glass and Polymer PFS

    Daniele Tartini, Business Development Manager for Glass Syringes, SCHOTT North America, Inc.

  • Current Covid-19 mRNA vaccines on the market are available in vials, which is great for vaccine time-to-market, but because of the drug preparation time and the potential risk for medical errors, vaccine manufacturers are looking for a second generation drug presentation in the form of a PFS. 
  • Because of the demanding requirements for the vaccine stability and the low temperature supply chain, multiple aspects of the PFS need to be considered. 
  • In this presentation we want to share our experience and data on syringe functionality and CCI to help accelerate mRNA manufacturers in their life cycle quest from vials into PFS.
  • clock

    14:40

    Assessment of structural integrity of biologics through simulated sub-cutaneous environment using the SCISSOR

    Deep S Bhattacharya, Senior Scientist, Pfizer

  • Structural assessment of simulated in vitro conditions of biologics using the SCISSOR
  • Understanding of destabilizing mechanisms of biologics in the sub-cutaneous environment
  • Deeper dive into peptide hotspots to identify potential sites for destabilization and re-iterative formulation development
  • clock

    15:20

    Afternoon Tea Sponsored by Zeon

    clock

    15:50

    Connected device considerations and the evolving digital landscape

    Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs - Devices and Combination Products, Takeda

  • An update on the evolving digital health landscape and how it has developed for combination products in recent years
  • An insight into regulations for connected devices and recent updates
  • Ensuring patient usability and human factors is kept at the forefront when adding connected features
  • A future outlook for digital health: forecasting the potential of connected delivery devices
  • clock

    16:30

    Product lifecycle development from pre-filled syringes to digital ecosystem

    John Schalago, Executive Director, Senior Global Program Director Regulatory Affairs, Novartis

  • Smart Device and connected health platforms – regulatory considerations and industry outlooks
  • Combination product lifecycle management and post market safety reporting for connected combination products
  • Software as a Medical Device and connected device regulatory submission case studies
  • clock

    17:10

    Technology and Design Considerations in Developing easy-to-adopt User Centric Products

    Jason Song, CTO, SureMed Technologies, Inc.

  • Implementing user centric design considerations when developing combination products
  • Product differentiation and using technology to better serve patients
  • How to balance between early technology adoption and innovation risks
  • Adapting to a changing landscape
  • clock

    17:50

    Chair’s Closing Remarks and Close of Day Two

    Gretchen Vandal, Sr. Director, Head of Global Regulatory Affairs - Devices and Combination Products, Takeda


    Founding Director, Ebenroth B.V.
    EPiWatch
    Associate Principal Engineer, Combination Products
    AstraZeneca
    Distinguished Scientist, Device Area Leader
    Merck & Co., Inc
    Business Development Manager for Glass Syringes
    SCHOTT North America, Inc.
    Senior Scientist
    Pfizer
    Technical Services Manager
    BD
    Associate Director, Global Regulatory Affairs Devices
    Sanofi US
    Sr. Director, Head of Global Regulatory Affairs - Devices and Combination Products
    Takeda
    Manager, Combination Products Laboratories
    Regeneron
    CTO
    SureMed Technologies, Inc.
    Associate Director for Policy and Product Classification Officer
    Food and Drug Administration
    Chief Commercial Officer
    Credence MedSystems
    Executive Director, Senior Global Program Director Regulatory Affairs
    Novartis
    Strategic Business Development Manager
    Zeon Specialty Materials
    Associate Director
    Takeda Pharmaceutical Company Limited
    Manager, Technical Product Development
    West Pharmaceutical Services, Inc.
    Technical Specialist & Scheme Manager
    BSI
    Head Enterprise Design & Innovation
    Johnson & Johnson
    Senior Director of Device Development
    Alexion Pharmaceuticals

    Sponsors

    Exhibitors

    Supporters

    Preliminary Attendees 2022

    Download

    Survey Results Infographic - State of the Industry 2022

    Download

    Preliminary Survey Results 2022

    Download

    Speaker Interview - Christine Lynn Lanning, Merck & Co., Inc

    Download

    Conference Chair Letter

    Download

    Chair & Speaker Biographies

    Download

    Workshop A Agenda

    Download

    Workshop B Agenda

    Download

    Pre Filled Syringes East Coast 2022 Brochure

    Download

    Past Attendees

    Download

    Past Presentation - Alie Jahangir, Janssen Pharmaceuticals

    Download

    Past Presentation - Megan Heft, AstraZeneca

    Download

    Past Presentation - Rajiv Gupta, Takeda

    Download

    Past Presentation - Tina Kiang, FDA

    Download

    Sponsors


    BD Medical

    Sponsors
    http://www.bd.com

    As a partner of choice for pharmaceutical and biotech companies across the globe, BD Medical - Pharmaceutical Systems provides a broad range of parenteral drug delivery systems including glass and plastic prefillable syringes, safety and shielding systems as well as advanced drug delivery solutions that help ensure pharma meets its drug delivery goals while considering drug complexity, viscosity and dosing volume.

    With an emphasis on patient-centered innovations and strong technical expertise, BD Medical - Pharmaceutical Systems partners with pharmaceutical and biotechnology companies to help them achieve their combination product commercialization goals. We support product launch and life cycle management through a comprehensive set of services and solutions that help to de-risk the combination product development process.

    More information available @ drugdeliverysystems.bd.com Contact us @ drugdeliverysystems.bd.com/contact-us



    Celanese

    Sponsors
    https://vitaldose.com

    Celanese offers the innovative VitalDose® Platform, for targeted ocular delivery of small molecules, biologics, and RNAi to treat conditions such as retinal diseases, glaucoma, and inflammation. VitalDose® EVA provides controlled drug release through implants and inserts. Compared to traditional dose forms, the VitalDose® platform reduces treatment burden, addresses patient adherence issues, and improves bioavailability. We partner with you to enable innovative drug delivery within your desired release profile. Collaborate with experts from our Development & Feasibility Lab to address your drug delivery challenges. We are equipped to design and fabricate functional, loaded prototypes, characterize prototype morphology and release, and provide technical transfer support. With decades of experience in medical and pharmaceutical applications, our customers trust us to provide unrivaled service, world-class expertise, and quality that improves development, enhances manufacturability, and elevates patient care.


    Credence MedSystems

    Sponsors
    http://www.credencemed.com

    Credence MedSystems is an innovator in injectable drug delivery devices. Credence’s philosophy of Innovation Without Change results in products that impress and protect end-users while preserving pharma’s existing processes, sourcing strategies and preferred primary package components. The Companion® family of syringe systems includes proprietary needle-retraction technology, reuse prevention and other critical safety and usability features in Staked and Luer needle formats. The Dual Chamber platform offers single-step mixing and injection for drugs requiring reconstitution at the time of delivery. Additional products such as metered dose devices, multi-length staked needles and other novel devices address the needs of specific therapeutic markets.


    Gerresheimer

    Sponsors
    http://www.gerresheimer.com

    Gerresheimer is the innovative system and solution provider and global partner for the pharma and biotech industry. The company offers a comprehensive portfolio of pharmaceutical containment solutions, drug delivery systems and medical devices as well as solutions for the health and cosmetics industry. The product range includes digital solutions for therapy support, medication pumps, syringes, pens, auto-injectors and inhalers as well as vials, ampoules, tablet containers, dropper bottles, other bottles and more. Gerresheimer ensures the safe delivery and administration of drugs to the patient. With 36 production sites in 16 countries in Europe, America and Asia, Gerresheimer has a global presence and produces locally for the regional markets. With over 11,000 employees, the company generated revenues of around €1.82bn in 2022. Gerresheimer AG is listed in the MDAX on the Frankfurt Stock Exchange (ISIN: DE000A0LD6E6).


    Nipro PharmaPackaging

    Sponsors
    http://www.nipro-group.com

    Nipro PharmaPackaging is specialized in developing and manufacturing advanced pharma packaging products and complete packaging solutions for early development drugs or the enhancement of packaging solutions for existing drugs. With a worldwide manufacturing footprint of 19 plants, multiple sales offices, and lab services, Nipro offers an exceptional service platform. Through our personnel, products, and services, Nipro PharmaPackaging enables you to provide a safer and healthier administration to your customers. Nipro PharmaPackaging is part of Nipro Corporation Japan, established in 1954. As a leading global healthcare company with over 35,000 employees worldwide, Nipro serves the Pharmaceutical, Medical Device, and Pharmaceutical Packaging industries.


    Schott

    Sponsors
    https://www.schott.com/en-us/markets/health/pharma

    SCHOTT is a global manufacturer of high-tech materials for specialty glass. With more than 130 years of experience, and represented in 34 countries, the company is a highly skilled partner for high-tech industries: Healthcare, Home Appliances & Living, Consumer Electronics, Semiconductors & Datacom, Optics, Industry & Energy, Automotive, Astronomy, and Aerospace. In the fiscal year 2020, its 16,500 employees generated sales of 2.24 billion euros. SCHOTT is one of the world’s leading experts for parenteral packaging and supplies the pharma industry with more than 12 billion syringes, vials, ampoules, and cartridges of tubing glass and polymer per year.



    Schreiner MediPharm

    Sponsors
    http://www.schreiner-medipharm.com

    Schreiner MediPharm is a leader in the development and manufacture of innovative specialty labels with value-added benefits for the pharmaceutical industry. The product portfolio includes labels with integrated hangers, with detachable parts and multi-page labels. Additionally, the company offers syringe labels with integrated needle protection, anti-tampering and counterfeiting protection solutions as well as NFC/RFID labels. These products simplify dispensing and administering of pharmaceuticals, enhance drug safety and clearly reduce process costs. Thanks to its strong solutions expertise and specialized know-how Schreiner MediPharm has established itself worldwide as a highly capable development partner and reliable quality supplier to leading pharmaceutical companies.


    SteriTek

    Sponsors
    http://

    Steri-Tek, based in Fremont, CA, with a new facility in Lewisville, TX is a high-volume E-beam/X-Ray contract sterilizer and R&D innovation center serving the medical device, biotech, pharmaceutical and other industries. Steri-Tek is an ISO 11137 and ISO 13485 certified, FDA registered, DEA licensed as well as State of California Medical Device and Drug Manufacturing licensed facility.

    The California facility boasts two state-of-the-art 10 MeV, 20 KW linear accelerators. The Texas facility utilizes two state-of-the-art 10 MeV, 30 KW linear accelerators.  Both offer simultaneous beam processing that allows for high volume production, providing uniform dose to the product without having to rotate the customer’s boxes. This DualBeam™ configuration significantly increases efficiencies, expands product options, and serves as an effective back-up for the accelerators. Steri-Tek has developed a proprietary system for radiation sensitive materials such as drugs/biologics, combination devices, bioabsorbables, implantables, advanced polymers and other complex products.

    Steri-Tek offers;

    • Turnkey Validation Services (per ISO 11137 VDmax and Method I)
    • Rapid Turnaround on Routine Sterilization Processing (48 hours standard with RUSH 24 hour and 4 hour turnaround available)
    • DualBeam™ E-beam/X-ray processing (Highest up time in industry)
    • Expert Consultation Services to optimize E-beam/X-ray sterilization processing and throughput of complex devices


    Terumo

    Sponsors
    https://www.terumopharmaceuticalsolutions.com

    Terumo Corporation, founded in 1921, is a global and innovative medical technology company of Japanese origin. Today – with almost 100 years of experience – Terumo offers you advanced technology for product design, development, quality management, manufacturing, logistics, customer service, and regulatory expertise. Our PLAJEX™ Ready-to-Fill polymer syringes have specific features that address several current issues with protein/peptide biopharmaceuticals, such as aggregation, viscous injection, and reduction of (sub-) visible particles. Among these features, PLAJEX™ syringes are steam sterilized and utilize proprietary i-coating™ technology, to provide a silicone oil-free platform for applications requiring low reactive containers. Terumo Corporation, “Innovating at the Speed of Life”.


    W.L. Gore & Associates, Inc

    Sponsors
    https://www.gore.com/products/industries/military

    Gore & Associates: Almost twenty years ago, Gore introduced what would be the first in the line of exciting innovations for pharmaceutical and biopharmaceutical customers—the GORE® LYOGUARD® Freeze-Drying Tray. Since then, we’ve developed many single- and multi-use products and process components—all with the express focus on improving the customer experience by applying our materials technology and engineering know-how to deliver step-change performance.


    West Pharmaceutical Services

    Sponsors
    http://www.westpharma.com

    West Pharmaceutical Services, Inc. is a leading provider of innovative, high-quality injectable solutions and services. As a trusted partner to established and emerging drug developers, West helps ensure the safe, effective containment and delivery of life-saving and life-enhancing medicines for patients. With almost 10,000 team members across 50 sites worldwide, West helps support our customers by delivering over 40 billion components and devices each year.

    Headquartered in Exton, Pennsylvania, and in business for nearly a century, West in its fiscal year 2020 generated over $2.15 billion in sales. West is traded on the New York Stock Exchange (NYSE: WST) and is included on the Standard & Poor's 500 index. For more information, visit www.westpharma.com.



    Zeon

    Sponsors
    http://www.zeonex.com

    ZEON’s Zeonex® and Zeonor® cyclo olefin polymer (COP) allow for advanced, break-resistant syringes, vials and lyophilization containers for protein-based biopharmaceuticals, high viscosity drugs, and contrast media.

    They also offer high purity, “glass-like” transparency, sterilization, low water absorption, and superior moldability, as well as overcome protein adsorption and ph shift concerns.

    Please visit our booth and discover why COP is an excellent choice for drug storage and pre filled syringes.


    Exhibitors


    Buamann Medical

    Exhibitors
    http://www.baumann-group.com

    BAUMANN MEDICAL is a reliable, experienced partner for tailor-made solutions in medical devices. As an independent division within BAUMANN Group our medical approach is a cornerstone of our corporate vision and long-term strategy. Our dedicated, ISO13485 certified medical sites addresses the customer needs in the medical and pharmaceutical industries. BAUMANN MEDICAL has the know-how, the capabilities, and the processes to fulfil the sector specific requirements and is therefore recognized as an expert in this field.

    A specialized medical team of professionals based in the USA, Europe, and Asia, works closely with customer teams to support the development of the best component for a device, as well as to provide the most valuable solution for a specific customer project.

    Thus our partners benefit from our expertise as a long-standing world-leading springs and stampings manufacturer. BAUMANN MEDICAL has the same high standard in business ethics, mind-set, and level of aspiration at all sites.

    More Information about the BAUMANN Group on www.baumann-group.com



    Owen Mumford

    Exhibitors
    http://www.owenmumford.com

    Owen Mumford Pharmaceutical Services is a specialist in the design, development and manufacture of injectable drug delivery systems for the pharmaceutical, biotech & generics industries. These include single dose and multidose reusable and disposable auto-injectors, pens and syringes for subcutaneous and intramuscular administration. Our innovative products are designed to meet both the need of our pharmaceutical partners and their patients by facilitating ease of use and improving safety and patient compliance. Our devices are also designed with aim of reducing complexity and risk for the pharmaceutical & biotech industry in the development of their combination products.

    For more information please visit https://www.ompharmaservices.com/



    PHC

    Exhibitors
    http://www.phchd.com/global/

    PHC Corporation of North America is a subsidiary of PHC Holdings Corporation, Tokyo, Japan, a global leader in Medical Devices, Healthcare IT and Life Sciences. With drug delivery devices, ultra-low temperature freezers, biomedical refrigerators and incubators, PHC offers technologies and solutions for pharmaceutical, life science and biotechnology applications across industries



    Polyplastics- TOPAS

    Exhibitors
    http://www.topas.com

    Polyplastics, is the leading maker of TOPAS COC (cyclic olefin copolymer), a glass-clear, incredibly pure, break-resistant plastic for drug delivery, including syringes and vials. The benign COC medical polymer presents a nonreactive surface for advanced molecules. Additionally, TOPAS COC offers high moisture and chemical resistance, barrier and UV transmission.



    Weiss-Aug

    Exhibitors
    http://www.weiss-aug.com

    The Weiss-Aug Group is your global partner for the design support, development, engineering and manufacture of medical devices and drug delivery components and sub-assemblies.

    With specialized knowledge and state-of-the-art equipment, The Weiss-Aug group delivers the latest technologies for Disposable Safety Products, Drug-Delivery Products, Orthodontics, Ophthalmic Disposables and Devices, Electrosurgery.


    Media Partners


    ONdrugDelivery Magazine

    Supporters
    http://ondrugdelivery.com

    ONdrugDelivery provides 30,000 readers throughout global pharma/biopharma, with the latest, most pertinent industry information and intelligence about the drug delivery-related ideas, technologies, services and products the sector is developing. Established in 2004, and trusted throughout the industry for its high quality contributions from leading drug delivery experts, ONdrugDelivery is a must for pharma / biotech industry professionals who need to know what’s going on in drug delivery. Subscribe online today to the print or free digital edition: www.ondrugdelivery.com/subscribe.


    PharmaVOICE

    Supporters
    http://www.pharmavoice.com

    PharmaVOICE magazine, and its supporting VIEW publications, provide commentary about the challenges and trends impacting the life-sciences industry, covering a range of issues from molecule through market. PharmaVOICE's more than 41,000 U.S.-based subscribers are also kept abreast of the latest trends through additional media resources, including WebSeminars, Podcasts, Videocasts, and White Papers.


    Mednous

    Supporters
    http://www.MedNous.com

    MedNous is a print publication and website about medical innovation in Europe. It carries exclusive interviews with companies that are at the forefront of medical technology, as well as contributor articles from prominent practitioners. Our mission is to identify significant advances in medicine and to explain how this innovation is being commercialised. In doing so, we talk to venture capitalists about what products and platforms they are supporting. We report on how regulators cope with the accelerating pace of innovation. And we regularly cover the latest developments in the discovery and development of new medical concepts in the area of antibodies, vaccines, small molecules, regenerative medicine and nanomedicines. MedNous combines the English word for medicine with the Greek word for intellect. And those with nous are readers of our publication. Visit our website: www.mednous.com


    Technology Networks

    Supporters
    http://go.technologynetworks.com/subscribe-to-newsletters

    Founded in 2000, Technology Networks is established as the leading news provider for life science and drug discovery professionals. In addition, we provide unique content including webcasts, videos, application notes and posters from recent conferences. Our portfolio now includes around 30 focussed scientific communities, all of which are accessible free of charge within TechnologyNetworks.com


    Pharmaceutical Technology

    Supporters
    http://www.pharmaceutical-technology.com

    Pharmaceutical-technology.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production. Pharmaceutical-technology.com brings you the latest in industry projects and updates, along with the news, views and trends that leading professionals – from senior executives to manufacturing managers and heads of procurement – require to stay on top of their field.


    Medical Design Briefs

    Supporters
    http://WWW.TECHBRIEFS.COM/SUBSCRIBE/MDB/SMIEAST21

    Medical Design Briefs (MDB) is the only publication for the medical OEM market dedicated to medical product design engineers and managers. We offer timely, accurate, quality content and editorial, and we report on engineering-related topics that are at the core of the latest medical technologies. From materials to manufacturing, we dive into the technical side of bringing medical devices to market. From biosensors to cybersecurity, we keep our fingers on the pulse of the hottest trends and topics that may augment or disrupt medical technology.


    Biocompare

    Supporters
    http://www.biocompare.com

    Biocompare.com is the leading resource for up-to-date product information, product reviews, and new technologies for life scientists. Biocompare combines an in-depth knowledge of life science products and new technologies with the power of the Internet to offer scientists the most dynamic, relevant, and innovative media-based marketplace for life science information.


    Drug Discovery Today

    Supporters
    http://www.drugdiscoverytoday.com/

    Drug Discovery Today covers the whole of the preclinical drug discovery process. The reviews are cutting edge, written by experts in their respective fields and cover all aspects of drug discovery from genomic and proteomic approaches, computational drug design, medicinal chemistry and the translation of these sciences to therapies.


    Pharmacircle

    Supporters
    http://www.pharmacircle.com

    PharmaCircle is an innovative knowledge management company serving the current and future global leaders in the Pharmaceutical and Biotechnology related industries. PharmaCircle is a one stop information and analysis source for pipeline, products, clinical trials, drug delivery technologies, deals and acquisitions, company financials, venture capital investments, product sales, pharmaceutical services, news, patents and more….


    Pharmalicensing

    Supporters
    http://www.pharmalicensing.com

    Pharmalicensing (www.pharmalicensing.com) is the premier biopharmaceutical Open Innovation resource designed for professionals involved with partnering, licensing and business development worldwide. Actively supporting all forms of partnering and in- and out-licensing activities, Pharmalicensing utilizes the unique online Showcase Profiling & Discover services, as well as its renowned Partnering Search service leveraging its global network of industry experts, to enable companies to identify and engage with appropriate partners around the world. Pharmalicensing is actively utilized by many tens of thousands of industry professionals each month. Pharmalicensing is a division of Cognis Group, Inc.


    pharmaphorum

    Supporters
    http://www.pharmaphorum.com

    pharmaphorum drives innovation within the pharmaceutical industry, by bringing healthcare together through a suite of media services that help produce and disseminate thought leadership, combined with an online platform for communicating messages to a global audience.Visit www.pharmaphorum.com


    ASD MEDIA

    Supporters
    http://www.asd-network.com

    Professionals in the Aerospace & Defence market use the ASD Media internet platforms to:
    • Be informed on the latest market developments; www.asd-network.com
    • Find the latest business news; www.asd-network.com
    • Find the upcoming events; www.asd-network.com
    • Find companies and organizations; www.asdsource.com
    • Distribute news globally. www.asdwire.com
    The ASD Media platforms are well known and used intensively, your company is able to benefit from these large numbers of users. Be informed with ASD-Network; Create exposure for your company with ASDSource, distribute your news with ASDWire or advertise with us, build your brand and increase traffic to your company’s website.

    For more detailed information please contact with: ASD MEDIA
    Stefan.koopman@asdmedia.nl


    Pharmaceutical Outsourcing

    Supporters
    http://www.pharmoutsourcing.com

    Pharmaceutical Outsourcing, the journal dedicated to pharmaceutical and biopharmaceutical contract services. With regular sections on contract manufacturing, contract research, contract packaging, formulation/development services, contract analytical testing, APIs, stability testing, clinical research and other areas, we bring the most complete coverage of trends and issues in the industry to our 15,000 readers in North America.


    Pharma Journalist

    Supporters
    http://www.pharmajournalist.com

    Pharma Journalist is a product of Kellen Media. Pharma Journalist is one of the leading website covering the need of global Pharmaceutical Industry. Articles like latest news, trends, analysis, market report, press releases, whitepapers, case studies, etc. published on pharmajournalist.com helps Industry professionals and decision makers to stay on the top of this fast-paced industry. Pharma Journalist aims of providing fast and informative articles to its readers and subscribers.


    Pharma network magazine

    Supporters
    https://www.pharmanetwork.digital

    PHARMAnetwork is a company specialized in publishing for the pharmaceutical industry. PHARMAnetwork has developed publications for CMO, CDMO and professionals working in the life sciences. PHARMAnetwork designs specialized studies for pharmaceutical companies, contract service providers and investment firms. PHARMAnetwork magazine covers, every aspect of pharmaceutical value chain, the change and developments in the intersection between pharmaceutical industry and outsourcing industry. We perform interviews and write articles whose thematic strategies, organizations, mergers and acquisitions, regulatory, innovation in the pharmaceutical development and contract manufacturing. https://www.pharmanetwork.digital


    Pharmiweb

    Supporters
    http://www.pharmiweb.com

    Established in October 2003, PharmiWeb Solutions is an energetic, innovative provider of web-based solutions for the pharmaceutical sector, with customers such as AstraZeneca, Roche, Servier Laboratories, and Merck With solutions in three key areas: Online Publishing, e-Business and Mobile Computing, we deliver connectivity – between people and applications – unlocking islands of data and knowledge. We own some of the sector’s most innovative Online Publications: PharmiWeb.com, HospitalPharma.com and Detail-Direct.com. We are actively developing solutions for Mobile Computing platforms. For example, our PharmiTabTM e-pharmacy solution runs real-time patient data and prescribing transactions in a busy hospital environment, on a TabletPC, wireless client/server platform. e-Business solutions range from e-Detailing, to Online Market Research, all designed to increase reach, increase sales, and to reduce administration and costs.


    American Pharmaceutical Review

    Supporters
    http://www.americanpharmaceuticalreview.com/

    American Pharmaceutical Review is the leading review journal for business and technology in the pharmaceutical industry throughout North America. Each issue offers American Pharmaceutical Review's 30,000 readers unbiased editorial coverage of the latest developments in: drug delivery, information technology, research & development, analytical development and control, equipment and facility manufacturing and regulatory affairs. With its in-depth coverage, American Pharmaceutical Review is able to keep its readership of senior executives, technical personnel, scientists, and others fully abreast of the latest trends and developments in the process of pharmaceutical manufacturing.


    Pharmaceutical-Tech

    Supporters
    http://www.pharmaceutical-tech.com

    In the realm of Pharmacy, where innovation is rapid, Pharmaceutical-Tech stands adept at conceptualizing unique ideas relevant to the B2B space. Pharmaceutical-Tech is essentially a B2B online business, technology media platform and global magazine that have under its wraps the largest global database of Pharmacy buyers and suppliers. Pharmaceutical-Tech.com covers in-depth trends that shape industry dynamics and metamorphose global economics. With services like search engine optimization, global magazine, social media marketing, product video showcase, e-mail marketing, e-newsletter sponsorship, banner advertising, event marketing and micro-website within our platform, www.pharmaceutical-tech.com has created a recognition that spans over a global audience, thereby revolutionizing how businesses transact.

    Sheraton Boston Hotel

    39 Dalton Street
    Boston 02199
    USA

    Sheraton Boston Hotel

    Travelers will reap benefits of Sheraton Boston Hotel's prime location in downtown Boston, in the thriving neighborhood of Back Bay. Nestled in the heart of the city, our hotel is directly connected to the Prudential Center and steps away from the many shops and restaurants of Copley Place. We're also within walking distance of Fenway Park, the Charles River, Copley Square and much more.

    Aside from a superior Boston, MA location, we also boast an unbeatable array of amenities for your convenience. Break a sweat in our hotel's state-of-the-art fitness center, enjoy the use of New England's largest indoor-outdoor saltwater pool or indulge in some pampering at Green Tangerine Spa & Salon, our full-service salon and spa. We also boast comprehensive meeting and event facilities, perfect for hosting both corporate functions and weddings in downtown Boston. However you choose to spend your time here, we can assure you that the best of the city will be within reach at Sheraton Boston Hotel.
     

    HOTEL BOOKING FORM

    Title

    SubTitle
    speaker image

    Content


    Title


    Description

    Download

    Title


    Description

    Download

    Title


    Description


    Download


    WHAT IS CPD?

    CPD stands for Continuing Professional Development’. It is essentially a philosophy, which maintains that in order to be effective, learning should be organised and structured. The most common definition is:

    ‘A commitment to structured skills and knowledge enhancement for Personal or Professional competence’

    CPD is a common requirement of individual membership with professional bodies and Institutes. Increasingly, employers also expect their staff to undertake regular CPD activities.

    Undertaken over a period of time, CPD ensures that educational qualifications do not become obsolete, and allows for best practice and professional standards to be upheld.

    CPD can be undertaken through a variety of learning activities including instructor led training courses, seminars and conferences, e:learning modules or structured reading.

    CPD AND PROFESSIONAL INSTITUTES

    There are approximately 470 institutes in the UK across all industry sectors, with a collective membership of circa 4 million professionals, and they all expect their members to undertake CPD.

    For some institutes undertaking CPD is mandatory e.g. accountancy and law, and linked to a licence to practice, for others it’s obligatory. By ensuring that their members undertake CPD, the professional bodies seek to ensure that professional standards, legislative awareness and ethical practices are maintained.

    CPD Schemes often run over the period of a year and the institutes generally provide online tools for their members to record and reflect on their CPD activities.

    TYPICAL CPD SCHEMES AND RECORDING OF CPD (CPD points and hours)

    Professional bodies and Institutes CPD schemes are either structured as ‘Input’ or ‘Output’ based.

    ‘Input’ based schemes list a precise number of CPD hours that individuals must achieve within a given time period. These schemes can also use different ‘currencies’ such as points, merits, units or credits, where an individual must accumulate the number required. These currencies are usually based on time i.e. 1 CPD point = 1 hour of learning.

    ‘Output’ based schemes are learner centred. They require individuals to set learning goals that align to professional competencies, or personal development objectives. These schemes also list different ways to achieve the learning goals e.g. training courses, seminars or e:learning, which enables an individual to complete their CPD through their preferred mode of learning.

    The majority of Input and Output based schemes actively encourage individuals to seek appropriate CPD activities independently.

    As a formal provider of CPD certified activities, SAE Media Group can provide an indication of the learning benefit gained and the typical completion. However, it is ultimately the responsibility of the delegate to evaluate their learning, and record it correctly in line with their professional body’s or employers requirements.

    GLOBAL CPD

    Increasingly, international and emerging markets are ‘professionalising’ their workforces and looking to the UK to benchmark educational standards. The undertaking of CPD is now increasingly expected of any individual employed within today’s global marketplace.

    CPD Certificates

    We can provide a certificate for all our accredited events. To request a CPD certificate for a conference , workshop, master classes you have attended please email events@saemediagroup.com

    Event Title

    Headline

    Text
    Read More

    I would like to speak at an event

    I would like to attend an event

    Group Booking

    Please complete the below form and a member of SAE Media Group’s booking team will be in contact within 24 hours

    I would like to sponsor/exhibit at an event

    SIGN UP OR LOGIN

    Sign up
    Forgotten Password?

    Contact SAE Media Group

    UK Office
    Opening Hours: 9.00 - 17.30 (local time)
    SAE Media Group , Ground Floor, India House, 45 Curlew Street, London, SE1 2ND, United Kingdom
    Tel: +44 (0) 20 7827 6000 Fax: +44 (0) 20 7827 6001
    Website: http://www.smgconferences.com Email: events@saemediagroup.com
    Registered in England - SMi Group Ltd trading as SAE Media Group




    Forgotten Password

    Please enter the email address you registered with. We will email you a new password.

    Thank you for visiting our event

    If you would like to receive further information about our events, please fill out the information below.

    By ticking above you are consenting to receive information by email from SAE Media Group.
    Full details of our privacy policy can be found here https://www.smgconferences.com/privacy-legals/privacy-policy/.
    Should you wish to update your contact preferences at any time you can contact us at data.privacy@smgconferences.com.
    Should you wish to be removed from any future mailing lists please click on the following link http://www.smgconferences.com/opt-out

    Fill in your details to download the brochure

    By submitting this form you agree to our privacy policy and consent to receiving communications, you may opt out at any time.