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Pre Filled Syringes East Coast
April 8 - April 9, 2019
Pre Filled Syringes East Coast

SAE Media Group presents its 6th Annual Pre-Filled Syringes East Coast 2019 Conference and Exhibition taking place on the 8th, 9th April in Boston.
This event will bring together specialists within the industry to provide an exclusive insight into the sphere of regulation, new digital technology trends, human studies and innovative design and delivery systems within the prefilled syringe industry. This comprehensive overview will help attendees understand the changing global market and the challenges faced within the industry.

This year’s agenda includes the following:
- New digital technology trends and evaluation of connectivity.
- Regulatory Processes and Challenges, including home-based administration and compliance within a fast-changing landscape.
- 21st century cures act and evaluation of article 117
- Innovative designs and drug delivery systems including device combination product challenges.
- The future of PFS, next generation syringes, biologics and addressing the emerging challenges of chemical compatibility.
- Interactive panel discussions led by industry experts.
- Development within injectables translated into device management.
 

 

sponsors

Conference agenda

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8:30

Registration & Morning Coffee

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9:00

Workshop Leaders' Introduction

Wenzel Novak

Wenzel Novak, Global Senior Director Business Development, Gerresheimer Medical Systems

Bernd Zeiss

Bernd Zeiss, Head of global technical support, Gerresheimer Medical Systems

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9:10

Market Overview

  • Syringe formats used in different applications
  • Reasons for an increased demand on polymer and still much higher demand on glass
  • Is COP the new trend?
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    9:55

    Battle” Glass vs. Polymer

    Bernd Zeiss

    Bernd Zeiss, Head of global technical support, Gerresheimer Medical Systems

  • Is cost and breakability all differentiation?
  • Permeability a no-go or just a niche restriction?
  • Customization opportunities
  • Technical standards, component integration and regulatory perspectives will be highlighted to support decisions
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    10:40

    Morning Coffee

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    11:10

    Case Studies

  • Protein absorption
  • Permeability / Migration
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    11:55

    Group: Create a decision matrix

    • Heparin - BioTech - Ophthalmic- Vaccines- Aesthetic
    • Summarize needs and decide for the best system
     

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    12:30

    Q&A / wrap up

    • Identify the best container material option for YOUR product

    Wenzel Novak

    Wenzel Novak, Global Senior Director Business Development, Gerresheimer Medical Systems

    Bernd Zeiss

    Bernd Zeiss, Head of global technical support, Gerresheimer Medical Systems

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    13:30

    Registration and Coffee

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    14:00

    Workshop leaders introduction

    Barry Sall

    Barry Sall, Senior Regulatory Consultant, PAREXEL

    Donald  N. Klein

    Donald N. Klein, Principal Consultant, PAREXEL International

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    14:10

    Breakout session

    • Identifying key issues related to both pharmaceutical and medical device components
    • Categorizing these issues with relation to regulatory, technical and business risks

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    14:25

    Discussion of key issues and their relative priorities

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    15:10

    Afternoon tea and networking break

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    15:40

    Breakout session

  • Formulate approaches
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    16:10

    Group Discussion

  • Questions from industry and regulator perspectives
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    17:00

    Final discussion and close of workshop

    Barry Sall

    Barry Sall, Senior Regulatory Consultant, PAREXEL

    Donald  N. Klein

    Donald N. Klein, Principal Consultant, PAREXEL International

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    18:00

    Sponsored Dinner

    This private dinner sponsored by a number of our key sponsors presenting a fabulous opportunity to debrief the content of the conference and formally continue networking.

    Dinner will be at Bugis street Brasserie at the Copthorne Tara Hotel Kensington London

     

    Places are limited to 40 so register to reserve your spot.

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    8:00

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

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    9:10

    Regulatory Processes and challenges within the constantly evolving Pre-filled syringes market

    Tina Kiang, Acting Division Director, CDRH/ODE/DAGRID, FDA

    - Thorough update on new regulatory guidelines and how to successfully comply
    - Strategy control for combination products 
    - Drug and device requirements for innovative designs
    - Challenges in applying device software regulation
    - Incorporating patient centricity into regulatory requirements
     

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    9:40

    The Impact of EU Medical Device Regulation on Combination Products and the Industry Challenges

    Hemal Mehta, Associate Director Global CMC-RA, Medical Devices and Combination Products, Janssen Pharmaceutical Incorporated

    • Overview of EU Medical Device Regulation (MDR), which becomes effective 26 May 2020
    • Impact of EU MDR Article 117, which requires Notified Body review of the device constituent of single-entity combination products
    • Challenges in interpreting Article 117 requirements, industry’s approach to addressing this uncertainty, and recent developments
     

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    10:10

    Morning Coffee: Sponsored by Zeon

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    10:40

    Comparing radiation modalities

    Larry Nichols, CEO, Steri-Tek

    • Differences with electron beam, gamma and x-ray with Case studies
    • Irradiation of the product with gamma
    • E-beam advantages - less colouration and less degradation
    • Disadvantages of e-beams.  Gamma has better penetration and can penetrate dense products
    • Introduce own research
     

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    11:20

    Challenges of integrating Combination Product Development into the drug development Process

    Amit Khanolkar, Director, New Product Development Quality Engineering, Janssen

    • Life cycle management of products and common hurdles at each step
    • Troubleshooting the big technical challenges in development and manufacturing 
    • Successful integration of human factor studies
     

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    12:00

    Partnering in the Development and Commercialization of Combination Products

    Carl Dabruzzi, Senior Manager, Product Management, West Pharmaceutical Services

    • Not all handheld injectors need to look and feel the same
    • Satisfying the need for a platform of wearable on-body injection systems
    • Integrated Solutions: Focus on what you’re good at and let your partner do the rest
    • Your partner’s engagement shouldn’t end when the product is launched
     

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    12:40

    Networking Lunch

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    13:40

    21st century cures act and how this new law has transformed digital health

    Linda Ricci, Associate Director, Office of Device Evaluation, FDA

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    14:10

    Evolution of regulatory strategy - creating a roadmap to define strategy and mitigate risks

    John Schalago, Head of GRA Devices and Applications, Emd Serono

  • Develop regulatory roadmap through cross-functional collaboration
  • Understand the life-cycle development plan for drug container closure and connected platforms
  • EU MDR considerations for developing the roadmap regulatory strategy
  • Importance of regulatory intelligence in developing the Regulatory Roadmap. Potential implications of recent FDA requirements
     
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    14:40

    The Role of Human Factors in Evaluating Innovative Injectables

    Nick Zampa, Sr Engineer Technical Development Human Factors & Risk Management, Biogeneral Incorporated

  • Early human factors techniques and tools for understanding user perspective and user needs
  • Conceptualizing injection devices in terms of innovation management
  • Linking the user perspective and usability into new product evaluation prior to development
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    15:20

    Afternoon Tea: Sponsored by Zeon

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    15:50

    Medical Apps: The User Interface is the Product

    Molly Story , Head of Global Usability Engineering and Risk Management, Sanofi

    • Identifying the primary users
    • Identifying the use cases and controlling the use-related risks
    • Iterative (Agile) formative testing to ensure the app satisfies the user needs
    • Final (summative) human factors validation testing
     

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    16:20

    Round table discussion session

  • Evaluation of the Medical Device Single Audit Program (MDSAP)
  • GDPR and it’s implications on digital health
  • Eliminating dosing errors
  • Syringe components
  • Brian Lewis, Senior Consultant Engineer, Eli Lilly and Company

    George Cusatis, Associate Director, Merck

    Molly Story , Head of Global Usability Engineering and Risk Management, Sanofi

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    17:40

    Chairman’s Closing Remarks and Close of Day One

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    8:30

    Registration & Coffee

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    9:00

    Chairman's Opening Remarks

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    9:10

    Exploring the Regulatory Environment for Combination Products

    George Cusatis, Associate Director, Merck

    • Understand the evolving regulatory landscape for combination products
    • Explore best practices for regulatory filings of combination products
    • Identifying post market safety reporting requirements for the US and EU
    • Understand evolving requirements for digital technology, such as mobile apps
    • Highlight the direction that combination products are heading
     

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    9:40

    Cyclo Olefin Polymer (COP) – Technical Data Update

    Larry Atupem, Sr Business Development Specialist, Zeon Specialty Materials

    • Key Properties of COP
    • Case study:  Biologics formulation for COP syringe optimized to eliminating use of surfactant.
    • Case study:  Study on Protein adsorption/aggregation – COP vs glass
    • Case study:  Study on delamination with glass syringe vs COP syringe
    • Leachable data on COP syringes with various chemicals
     

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    10:20

    Morning Coffee

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    10:50

    Control strategy and design transfer for pharmaceutical delivery device combination products


    • Establish control strategy (CS) for PFS manufacturing including device constituent parts
    • Develop CS for delivery device during design transfers to identify critical quality attributes (CQAs) for device constituent parts.
    • Generate a set of controls, e.g. incoming, in-process, release and/or stability specifications for delivery device manufacturing
    • Promote communication between device and drug development groups, development and manufacturing groups, pharma company and device component suppliers
    • Recognize the difference between delivery device and drug: drug focused more on process parameter (e.g. CPP) and device focused more on material attributes (e.g. CMA)
     

    Ling Lu, Senior Principal Scientist, Pfizer

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    11:20

    The best plastic syringe for biologics

    Shota Arakawa, Researcher , Mitsubishi Gas Chemical Company, Inc.

    • Assessing the downfalls of glass focusing on drug interference examples 
    • Introduction of advanced polymer materials that are biocompatible with other components of the syringe
    • Oxygen permeability for glass vs plastic 
    • Innovative device systems to improve gas barrier 
     

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    12:00

    Networking Lunch

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    13:00

    Advance Injection Time Modeling for PFS/Autoinjector (AI) Combination Product

    Joyce Zhao , Device Lead, Combination Product Device Development, Takeda Pharmaceuticals International

  • An advanced mathematic model developed to predict the injection time and real time flow rate of the PFS/AI.
  • The model is advanced than standard injection time model as it accommodate the spring force as non-constant and the injection speed is non-constant in results. The model is based on Newton’s Law of Motion, Hagen-Poisuille Equation and Finite Difference Method.
  • Monte Carlo simulation is utilized to analyse the design parameter (PFS geometry, needle ID, needle length, AI design parameters, etc.) sensitivity, perform virtual manufacturing trial to obtain variability of injection time and optimize the design parameters to meet the predefined drug delivery requirement.
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    13:30

    Design the container around the device – benefits of primary container customization with cyclic olefin copolymers for large volume injectors

    Patrick Gallagher, Business Development Manager, SCHOTT AG - Pharmaceutical

    • Different wearable device options on the market and their primary container requirements
    • The benefits of cyclic olefin copolymer primary container customization for devices
    • A few case studies on primary container customization
     

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    14:10

    Early stage device development and understanding cyber security.

    Michael Song, Sr. Manager, Drug Delivery and Device Development, Medimmune

    • De-risk evaluation in terms of early stage device development
    • Digital estimations in terms of challenges for patience use and product integrity. 
    • Case study evidence to advise against rushing digital tools to the market and how to ensure they are robust enough
    • Advice on cyber security with new devices and the challenges within field.
     

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    14:40

    Advance Prefilled Syringe Development and Robust Development Approach

    Douglas Cusato, Director of the Medical Rubber Business , Sumitomo Rubber

    - Reducing patient risks with innovative elastomeric components
    - Minimizing design verification failures, using extreme sterilization conditions and advanced simulation tools
    - Ensuring product robustness via a probabilistic approach
     

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    15:10

    Afternoon Tea: Sponsored by Zeon

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    15:40

    Effects of aging and transportation of pre-filled syringes on device performance

    Brian Lewis, Senior Consultant Engineer, Eli Lilly and Company

    ·          Establishing initial component and system injection functionality behaviour

    ·          Elucidating the effects of component and system aging on syringe glide force and device performance

    ·          Understanding the physical effects of transportation on prefilled syringes

     
     

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    16:10

    Challenges in developing high concentration formulations for combination products

    Ramin Samadani, Scientist, MedImmune

    • Importance of viscosity on injection force
    • Excipients used to reduce intermolecular interactions
    • Effect of shear thinning on injection time
     

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    16:40

    Chairs Closing Remarks and Close of Day Two

    Sponsors and Exhibitors

    Official Media Partner

    Supporting Media Partners

    Supporters

    PF Syringes 2019 Attendee List

    Download

    2019 PFS East Coast Brochure

    Download

    Interview with Cedric Gysel from Johnson and Johnson Device

    Download

    Interview with Patrick Gallagher, SCHOTT Pharmaceutical Systems

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    Interview with Douglas Cusato from Sumitomo Rubber

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    Interview with Bernd Zeiss from Gerresheimer Medical Systems

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    2019 PFS East Coast Speaker Line-Up

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    Interview with Hemal Mehta from Janssen Pharmaceutical Incorporated

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    Interview with Dhairya Mehta from Shire

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    Pre-Filled Syringes East Coast 2019 Programme

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    A Retrospective Approach to Design Transfer of Commercialized Products

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    Future of Digitally Connected Device and Changing Paradigm in Disease Management

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    Drug-Device Combination Product Development Challenges

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    2019 PFS East Coast Chair Letter

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    2018 PFS East Coast Attendee List

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    PFS Info Graphic 2018

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    Sponsors and Exhibitors


    3P Innovation

    Sponsors and Exhibitors
    http://www.3pinnovation.com

    3P provides device development and custom automation that help customers de-risk and commercialise faster at lower cost. We manufacture scalable machines, from lab-scale to full-scale production for sterile processing, powder and liquid fill-finish, assembly and test. Specialists in novel primary drug containers, reconstitution, wearable devices, auto-injectors, depots, cartridges and specials.


    Aptar Pharma

    Sponsors and Exhibitors
    http://www.aptar.com/pharma

    Aptar Pharma is a leading provider of innovative drug delivery systems to pharmaceutical, consumer healthcare and biotech customers worldwide, enabling safe, convenient and compliant medication delivery. Trusted partner of the pharmaceutical community, we provide our customers with a large range of specialized drug delivery devices, components and analytical services backed by decades of proven expertise. We have broad therapeutic expertise in Nasal, Pulmonary, Injectables, Eye Care and Dermal delivery routes, among others. Our global manufacturing footprint of sites in Argentina, China, France, Germany, India, Switzerland and the U.S. provides security of supply and local support to our customers. For more information visit: www.aptar.com/pharma


    CSS (Connecticut Spring & Stamping)

    Sponsors and Exhibitors
    http://www.ctspring.com

    CSS (Connecticut Spring & Stamping) is a customer-focused advanced manufacturing company. We engineer and manufacture precision metal springs, stampings, metal forms and assemblies, especially for the medical device industry. Our experience ranges from auto-injectors and infusion devices, to surgical instruments, sensors and wearables. CSS facilities are ISO 13485 certified. Leading OEMs and CMOs partner with CSS for design assistance and consistent volume production.


    Harro Höfliger

    Sponsors and Exhibitors
    http://www.hoefliger.com

    Harro Höfliger specializes in the development of customer-oriented process and production solutions for pharmaceutical and medical applications as well as market-oriented consumer products. In addition to innovative machine platforms and packaging machines, customized turnkey system solutions for product assembly, processing of web materials, as well as dosing and inhalation technology are the company’s core expertise.

    The systematically structured portfolio of upscalable test machines and modules, as well as requirement-oriented technology platforms, results from many years of experience and targeted research and development. Thus, Harro Höfliger covers all phases from the laboratory stage to high-performance production.



    Lonstroff

    Sponsors and Exhibitors
    http://www.lonstroff.com

    Lonstroff is a partner that offers all services related to elastomeric solutions from a single source. We advise our customers not only in the new development and optimization of materials, but also in their applications and in value analysis. Thanks to our experience, we are also able to provide valuable support with the registration and approval of the products.


    Mitsubishi Gas Chemical

    Sponsors and Exhibitors
    https://www.mgc.co.jp/eng/products/abd/oxycapt.html

    Mitsubishi Gas Chemical is a leading company in the field of oxygen barrier and absorbing technologies. Based on these technologies and experiences, we have successfully developed multilayer plastic vial and syringe having excellent oxygen, ultra violet and water vapor barrier. The products make it possible to replace glass with plastic for injectable drugs.


    NN Life Sciences

    Sponsors and Exhibitors
    http://www.nninc.com

    NN Life Sciences creates a partnership with its customers by providing premier industrial engineered solutions from the inception of a project to its completion. Strategically located in the USA, Europe, and Asia, NN Life Sciences works with customers in the development of value engineered products, while driving down costs, adhering to regulatory compliance protocols, with a clear understanding of market dynamics. Our commitment to excellence is evident throughout the design, validation, and advanced manufacturing of cases and trays, reusable and single-use surgical instruments, implantable components, drug delivery and other medical devices.


    Owen Mumford

    Sponsors and Exhibitors
    http://www.ompharmaservices.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.


    PHC Corporation

    Sponsors and 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

    Sponsors and Exhibitors
    https://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, vials and cartridges. 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.


    RheoSense

    Sponsors and Exhibitors
    http://www.RheoSense.com

    RheoSense viscometers offer the smallest sample volume per measurement coupled with exceptional ease-of-use and accuracy. We are the leader in biotechnology, pharmaceutical, and the emerging protein therapeutics industries. RheoSense instruments have been rigorously tested, approved, and adopted worldwide by Fortune Global 500 companies and leading research universities.


    SCHOTT

    Sponsors and Exhibitors
    http://www.schott.com/pharma

    SCHOTT is a leading supplier of primary pharma packaging and analytical lab services. We provide quality solutions while meeting the highest demands. Our product portfolio includes ampoules, syringes, cartridges and vials made of glass and COC polymer. Our facilities and products comply with international standards for pharmaceutical needs.


    Steri-Tek

    Sponsors and Exhibitors
    http://www.steri-tek.com

    Steri-Tek 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 a ISO 11137 and ISO 13485 certified, FDA registered, DEA registered as well as State of California Medical Device and Drug Manufacturing licensed facility. Particularly with sensitive materials and complex devices, Steri-Tek has developed a proprietary system for optimizing E-beam/X-Ray sterilization of drugs/biologics in combination devices, pre-filled syringes, implantables, bioabsorbables and other complex products.


    Sumitomo Rubber Industries

    Sponsors and Exhibitors
    http://hybrid.srigroup.co.jp/en/products/cleanrubber/

    Since our founding in 1909 as the first modern rubber factory in Japan, we at Sumitomo Rubber Industries have strived to produce advanced, environmentally friendly products based on the latest innovations in rubber technology. Within the medical rubber group, we are focused on providing the highest quality products, and ultimately dedicated to improving the lives of people around the world. Utilizing the latest in material and process innovations and our global manufacturing footprint, our team members work diligently to ensure we deliver consistent high performing products and provide strong assurance of supply.


    West Pharmaceutical Services, Inc.

    Sponsors and Exhibitors
    http://www.westpharma.com/

    West Pharmaceutical Services, Inc. is a leading manufacturer of packaging components and delivery systems for injectable drugs and healthcare products. Working by the side of its customers from concept to patient, West creates products that promote the efficiency, reliability and safety of the world's pharmaceutical drug supply. West is headquartered in Exton, Pennsylvania, and supports its customers from locations in North and South America, Europe, Asia and Australia. West's 2017 net sales of $1.6 billion reflect the daily use of approximately 112 million of its components and devices, which are designed to improve the delivery of healthcare to patients around the world.


    ZEON

    Sponsors and Exhibitors
    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.

    Media Partners


    Pharmavision

    Official Media Partner
    http://www.pharmavision.co.uk

    PharmaVision offers a consultancy service providing independent pharmaceutical thematic research to the healthcare industry, the investment community and competitive intelligence specialists. We perform due diligence research and provide expert commentary in healthcare. Our reports combine scientific analysis in drug delivery, R&D technologies and pharmaceutical products including patient modelling, product/technology forecasts and market trends evaluation.


    American Pharmaceutical Review

    Official Media Partner
    http://www.americanpharmaceuticalreview.com

    Start receiving your free copy today. American Pharmaceutical Review is a review of the drug pipeline from the late discovery phase through manufacturing. American Pharmaceutical Review prides itself on having the most relevant, unbiased and informative editorial in the industry. You will find that all of our editorial is highly technical and written by government agencies, consultants, academics, and large pharmaceuticals companies. American Pharmaceutical Review covers several key topics that are important to drug production:Separations and purification, Drug Delivery, Biopharmaceutical Processing, Biopharmaceutical Development, Formulation development, Manufacturing, Microbiology, Instrumentation, Spectroscopy


    American Laboratory

    Official Media Partner
    http://www.americanlaboratory.com

    For laboratory managers and researchers utilizing analytical chemistry and its applications, seeking knowledge on new technologies, methods, applications, and products, the American Laboratory® publication platform provides comprehensive technology coverage for laboratory professionals at all stages of their careers. Unlike single-channel publications, American Laboratory® is a multidisciplinary resource that engages scientists through print, digital, mobile, multimedia, and social channels to provide practical information and solutions for cutting-edge results. American Laboratory® serves the need of global community of laboratory professionals for communicating relevant technical advances and insights. Globally, American Laboratory® reaches out to subscribers by offering digital distribution plus premium print in North America. Digital communications utilize internet, mobile and social channels.


    Pharmaceutical Outsourcing

    Official Media Partner
    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.


    ONdrugDelivery Magazine

    Official Media Partner
    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.

    Media Partners


    Drug Discovery Today

    Supporting Media Partners
    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.


    Drug Development & Delivery

    Supporting Media Partners
    http://www.drug-dev.com

    Drug Development & Delivery is a print/online content provider that presents the latest scientific methods in drug development for professionals.


    Pharmacircle

    Supporting Media Partners
    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….


    International Pharmaceutical Industry (IPI)

    Supporting Media Partners
    http://ipimediaworld.com/

    IPI – International Pharmaceutical Industry IPI – was established to fill in the void for effective marketing and communication between all stakeholders in the Life sciences sector globally. Edited by our carefully selected editorial advisory panel, and extensive research network, IPI provides a proven supportive means of communication to the pharmaceutical, bio pharmaceutical, nutraceutical and medical devices industry the latest in research and technology innovations, regulatory guidelines, marketing and communication strategies which will enable them to be more efficient, bring products to market faster, reduce cost and make healthcare accessible to all.

    Media Partners


    Farmavita

    Supporters
    https://farmavitar.com

    FarmavitaR+ is the professional network of experts and service providers. Network is gathering local consultants from 90 countries in Europe, Asia, North America, Latin America, Australia and Africa. Management of international, multi-centre projects is our core competence. FarmavitaR+ is providing solutions related to pharmaceutical, medical device, food supplement and cosmetic products. Scope of services is related to solutions for product development, quality assurance, clinical trials, product registration, portfolio analysis, lifecycle management, vigilance/risk management, pricing/reimbursing, market access and promotional compliance. FarmavitaR+ is brand name of Farmavita Regulanet Ltd. Visit https://farmavitar.com for more information. Outsource anything you can think of!

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    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

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    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




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