Home
Pharmaceutical Microbiology West Coast
7 June - 8 June 2018
Pharmaceutical Microbiology West Coast

SAE Media Group proudly presents the 2nd Annual Pharmaceutical Microbiology West Coast Conference, in San Diego, USA, on the 7th and 8th of June 2018.
The pharmaceutical microbiology field is an ever-present constant in almost all areas of pharmaceuticals.Therefore, professionals within the field need to be informed and updated on the revised regulations and newly emerging methods and practices.

Join us to discuss and address the evolving issues facing this industry, such as: the aseptic practice and contamination prevention, mycoplasma testing, water monitoring and biofilms.

sponsors

Conference agenda

clock

8:30

Registration & Coffee

clock

9:00

Opening Remarks and Introductions

Ziva Abraham

Ziva Abraham, Founder and CEO, Microrite

Morgan  Polen

Morgan Polen, Subject Matter Expert on Contamination Control, Microrite

clock

9:10

Session 1: Case Study Review: LOearn from the mistakes of Others

  • Case Study: Poorly design Aseptic Filling Line and Monitoring Program leading to media fill and product failures.
  • Case Study: Poorly chosen Monitoring Equipment and Integration.
  • Case Study: Inadequate Air Flow Visualization Studies leading to incorrect (not risk-based) monitoring locations.
  • clock

    9:50

    Session 2: Understanding the changes to cleanroom standards (14644-1,2,3) and current regulatory thinking regarding GMP Annex 1; and discussion on recent 483 observations and waning letters

    clock

    10:30

    Morning Coffee

    clock

    11:00

    Session 3: Key Elements of Risk-Based Monitoring Program

  • Site selection
  • Media selection and management
  • Equipment selection and calibration
  • Frequency of monitoring
  • Analyzing EM data to asses risk
  • clock

    11:40

    Session 4: Group Exercise

  • Attendees will select risk based sample sites for a "Virtual Aseptic Filling Line" based upon this course material. Attendees will provide justification for their site selection.
  • clock

    12:20

    Closing Remarks and End of Workshop

    clock

    13:30

    Registration and Coffee

    clock

    14:00

    Opening Remarks and Introductions

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

    clock

    14:10

    Session 1: Introductions and technology options

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

  • An introduction to the current technologies used for microbial contamination control
  • The current technology options available to the industry
  • Pros and cons of methods with respect to current availability in the commercial market
  • clock

    14:40

    Session 2: Technical aspects of sensing

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

  • Spectrometric methods
  • Optical methods used for sensing
  • Operating principles and their relation to microbial attributes
  • clock

    15:00

    Afternoon Tea

    clock

    15:30

    Session 3: Implementation of strategies

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

  • Practical aspects of the implementation of these strategies
  • Hurdles to overcome during and after implementation
  • Case studies of implementation
  • clock

    16:00

    Session 4: Validation pitfalls to avoid

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

  • The best validation methods to use
  • Pitfalls and issues which need to be circumvented
  • Regulatory considerations
  • clock

    17:00

    End of Workshop

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Ziva Abraham

    Ziva Abraham, Founder and CEO, Microrite

    clock

    9:10

    Fungal and bacterial spore excursions in cleanrooms – case studies

    Jim Polarine

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

  • The industry has seen an increase in the number and species of bacterial endospores and mold spores found in many facilities.  This presentation will focus on ways to proactively limit bacterial and mold spore contamination from incoming items into cleanrooms and limit other sources of spore contamination.
  • Current industry regulations in the US and Europe will be discussed related to sporicides and disinfectants.  Additionally, the presentation will convey a robust approach to addressing bacterial and fungal spores by covering personnel practices, incoming items into cleanrooms, facility design and conditions, and the products used to address bacterial and mold spores as well as more resistant bacterial spore species such as Bacillus cereus.
  • New and recent case studies will be covered which focus on new antimicrobial chemistries and their performance against fungal and bacterial spores in cleanrooms.  The attendees will ascertain a better approach to root causes and determining sources of spore contamination in their cleanroom and controlled facilities.

     


     

  • clock

    9:50

    Rapid microbial methods – a case study of implementation

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

  • The implementation of rapid methods in practice, how best to adopt these new methods and keep up with developments
  • Validating the methods and conforming to regulatory requirements
  • The issues surrounding the implementation of rapid methods and how to overcome them
  • How to best tailor your implementation proposal in terms of validation of your rapid method
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    BET testing: strategies for testing difficult samples

    Veronika Wills

    Veronika Wills, Technical Services Specialist, Associates of Cape Cod

  • A short overview of the Bacterial Endotoxin Test methodology
  • Potential interactions between the matrix and assay components rendering the samples difficult to test
  • Strategies by sample type
  • Presenting a case study
  •  

    clock

    11:40

    Changing a Paradigm: Developing a Roadmap to implementing a Real Time Microbial Detection Analyzer in Pharmaceutical Water

    Mike Russ

    Mike Russ, Manager, QC Microbiology, Genentech Inc

  • Evaluating the potential for comparing Auto Fluorescent Units (AFU) to Colony Forming Units (CFU)
  • Discuss results of a study that evaluated the 7000RMS in a GMP Water for Injection system
  • Setting alert and action limits
  • Detail next steps: evaluation phase to implementation
  • clock

    12:20

    Networking Lunch

    clock

    13:30

    Strain Typing: A valuable tool for tracking microbial contamination

    Bindhu Verghese

    Bindhu Verghese, R&D Sr Staff Scientist Microbial Solutions, Charles River Laboratories

  • Overview of microbial identification methods
  • Assessment of identification platforms for species to strain-level characterization
  • Utility of microbial strain typing in the pharmaceutical industry
  • Tracking strains - Case studies
  • clock

    14:10

    Introduction to a Global Disinfectant Efficacy Study Approach

    Lisa Yan

    Lisa Yan, Principal Quality Laboratory Associate, Shire plc

  • Leveraging multi-site data within a company
  • Selection of representative surfaces and environmental in-house isolates
  • Developing a Global disinfectant efficacy study: Considerations and Challenges
  •  

    clock

    14:50

    Afternoon Tea

    clock

    15:20

    Underlying issues behind microbiological data deviations and data integrity

    Ziva Abraham

    Ziva Abraham, Founder and CEO, Microrite

  • Microbiological data deviations, investigations and data integrity related FDA observations are on the rise throughout the pharmaceutical arena. Any of these deficiencies can be avoided with a contamination control mind-set from the get go
  • Microbiological data deviations occur due to many reasons; inadequate facility, barrier design and airflows visualization studies. inadequate process/laboratory controls, lack of understanding of gowning and cleaning are also a factor. Case studies to demonstrate this
  • Main reasons for deviant EM data and data integrity


     

  • clock

    16:00

    PANEL: Hot topics in the cleanroom industry

  • Disinfection and disinfection qualifications
  • New technologies to be implemented and barriers to implementation
  • An adaptation to the cleanroom practices which are currently in place 
  • Jim Polarine

    Jim Polarine, Senior Technical Service Manager, STERIS Corporation

    Ziva Abraham

    Ziva Abraham, Founder and CEO, Microrite

    Andrew Bartko

    Andrew Bartko, Research Leader, Battelle Memorial Institute

    Mike Russ

    Mike Russ, Manager, QC Microbiology, Genentech Inc

    clock

    16:40

    Chairman’s Closing Remarks and Close of Day One

    clock

    8:30

    Registration & Coffee

    clock

    9:00

    Chairman's Opening Remarks

    Ziva Abraham

    Ziva Abraham, Founder and CEO, Microrite

    clock

    9:10

    How the technologies in pharmaceutical microbiology could be applied, utilised and translated into other fields

    Austin Swafford

    Austin Swafford, Director of Research, Center for Microbiome Innovation

  • Case studies to show that the human microbiome is affected by large amounts of environmental influences e.g. chemicals released into the environment could end up in the water systems
  • As such, water microbial detection techniques and environmental monitoring equipment could be used and applied to human biology
  • How technology used in pharmaceutical microbiology could be developed and applied to human diagnostics e.g. quick diagnostic testing derived from RMM
  • clock

    9:50

    Combining genetics with traditional methods to increase accuracy in microbial ID

    Elia Sanchez

    Elia Sanchez, QC Microbiology Sr. Manager, Genentech

  • Summary of the Genetic Analysis Technology
  • Bacterial ID vs Fungi ID
  • Exceptions to the rules
  • Traditional methods (Back to the basics case studies)
  • clock

    10:30

    Morning Coffee

    clock

    11:00

    Controversies and questions about non-sterile bioburden testing

    Heidi Anderson

    Heidi Anderson, Principal Scientist, Microbiology, Abbott Laboratories

  • Bioburden testing and monitoring for the non-sterile manufacturer
  • Establishing a microbiological testing program that makes sense for your product
  • How to manage challenges, controversies and questions about non-sterile bioburden testing
  • clock

    11:40

    An analysis of the arising abandonment of rapid methods following approval

    Ron Smith

    Ron Smith, Director, External Supply Integration Quality, Janssen

  • The process to rapid method implementation and approval
  • The increasing prevalence of the abandonment of these methods following implementation
  • A question and analysis into why this occurs   
  • clock

    12:20

    Networking Lunch

    clock

    13:30

    The background and implementation of mycoplasma testing

    Meghan May

    Meghan May, Associate Professor of Biomedical Sciences, Microbiology and Infectious Disease, University of New England

  • The PCR approach of mycoplasma testing vs the growth method – what are the similarities and differences between the two approaches?
  • The conceptual backing behind mycoplasma testing – what the test is hoping to achieve
  • Should rapid in-house testing be favoured or contract manufacturing or the test?
  • clock

    14:10

    How rapid mycoplasma safety testing could revolutionise quality control and lot release in biopharmaceutical manufacturing

    Renate Rosengarten

    Renate Rosengarten, Professor and Chair of Bacteriology and Hygiene, University of Veterinary Medicine Vienna

  • Safety issues - why are mycoplasmas of major concern in biopharmaceutical processes
  • Regulatory overview for mycoplasma testing
  • Current trend towards automated PCR-based in-process control and lot release mycoplasma testing
  • Product-specific multi-step mycoplasma PCR validation concepts 

     

  • clock

    14:50

    Current regulatory thinking on Data Integrity and CSV

    Chinmoy Roy

    Chinmoy Roy, Senior Consultant, Microrite

    An understanding of Data Integrity and its dimensions
    Examination of recent Warning Letters to obtain perspective of recent audit trends
    What factors to consider in remaining ready for unannounced Data Integrity audits
    Understand management’s key role in making company’s Data Integrity program a success

    clock

    15:30

    Afternoon Tea

    clock

    16:00

    Close of Day Two

    Sponsors and Exhibitors

    Official Media Partner

    Supporters

    Conference Program

    Download

    2018 Attendee List

    Download

    Updated Brochure Download

    Download

    Speaker Interview Heidi Anderson, Abbott Lab

    Download

    Speaker Interview Mike Russ, Genetech

    Download

    Speaker Interview Lisa Yan, Shire PLC

    Download

    Pre-Conference Workshops

    Download

    Invite from the Chair - Ziva Abraham

    Download

    2017 Post Event Infographic - Pharma Microbiology West Coast

    Download

    Sponsor insight - Press Release

    Download

    Past Attendee List

    Download

    Sponsors and Exhibitors


    Associates of Cape Cod, Inc.

    Sponsors and Exhibitors
    http://www.acciusa.com/acc/index.html

    Specializing in chromogenic and turbidimetric reagent technologies, Associates of Cape Cod, Inc. (ACC) has been a leader in endotoxin and (1?3)-ß-D-glucans detection products and services for more than 40 years. ACC pioneered LAL testing methodology and was the first FDA licensed company to manufacture LAL reagents.


    bioMérieux

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

    bioMérieux provides a wide range of solutions for microbiological control dedicated to the pharmaceutical industry. bioMérieux provides solutions for in-process controls and final product testing. From surface and personnel monitoring to air sampling, microbial detection and identification, bioMérieux helps the pharmaceutical industries manage microbiological risks and achieve compliance.


    BioVigilant

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

    BioVigilant Instantaneous Microbial Detection™ instruments provide continuous, real-time results for monitoring of air and water. IMD® instruments determine particle size and biological status…simultaneously. No sample preparation or growth required. Visit with us to learn more about protecting your bottom line from the disastrous effects of microbial contamination.


    Charles River

    Sponsors and Exhibitors
    http://www.criver.com/microbialsolutions

    For over 30 years, Charles River has helped customers bring products to market safely and efficiently with revolutionary technologies and exceptional services that have changed the way we conduct microbial quality control. Continuing with a passion to innovate and respond to customers’ needs, our Microbial Solutions group has purposefully expanded its global portfolio to include the leading rapid microbial detection systems of Celsis®. Joining the trusted brands of Endosafe® endotoxin testing and Accugenix® microbial identification, Celsis® creates a powerful trio of micro QC solutions, the most comprehensive offering available from any single provider.


    Fujifilm Wako

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

    Long recognized as a world-renowned supplier of high purity chemicals, Fujifilm Wako has dedicated more than 30 years of research and development to providing innovative endotoxin-specific reagents and consumables for “every user and for every method”. Visit us at www.wakopyrostar.com to learn how Fujifilm Wako can best support your quality testing needs.


    Novatek

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

    Novatek International provides the building blocks for a complete quality management software solution that can be tailored to any client’s needs. From standalone modules to integration with other modules forming large-scale comprehensive solutions, Novatek’s 20+ years of successful global implementations, extensive user requirements, and regulatory knowledge ensures your organization compliance and peace of mind during audits.


    Rapid Micro Biosystems

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

    Rapid Micro Biosystems is an innovative life sciences technology company providing mission critical automation solutions to facilitate the efficient manufacturing and fast, safe release of healthcare products such as biologics, vaccines, cell and gene therapies, and sterile injectables. The company’s flagship Growth Direct® platform automates and modernizes the antiquated, manual microbial quality control (MQC) testing workflows used in the largest and most complex pharmaceutical manufacturing operations across the globe. The Growth Direct® platform brings the quality control lab to the manufacturing floor, unlocking the power of in-line/at-the-line MQC automation to deliver faster results, greater accuracy, increased operational efficiency, better compliance with data integrity regulations, and quicker decision making that customers rely on to ensure safe and consistent supply of important healthcare products. The company is headquartered and has U.S. manufacturing in Lowell, Massachusetts, and global locations in Switzerland, Germany, and the Netherlands.


    Roche CustomBiotech

    Sponsors and Exhibitors
    http://www.custombiotech.roche.com

    Building on decades of experience as a diagnostics and pharmaceutical manufacturer, Roche CustomBiotech offers a broad range of innovative products and services for in vitro diagnostics, biopharmaceuticals, and cell and gene therapy markets. Some specific product categories include enzymes, high resolution cell counter, robust and reliable photometric-based bioanalyzers, and rapid PCR-based quality control assays for in-process testing and product release. With our extensive industry experience and strong customer orientation, Custom Biotech is committed to helping you achieve success across all stages of the development process.

    Media Partners


    pharmanews hq

    Official Media Partner
    http://http://pharmanewshq.com

    MedChemNet provides a unique and unparalleled platform for the medicinal chemistry community to share insights, discuss the latest research, and help move the field forward. MedChemNet covers all aspects of the drug discovery pipeline, from target identification and validation, through computer aided drug design (CADD), synthesis, screening and other biophysical techniques, to development of novel lead compounds and pre-clinical in vivo proof of concept. We also cover the design of synthetic drug delivery carriers and ADME/toxicology studies, as well as intellectual property and economic related issues. Website: Welcome to Pharma News HQ, the journal dedicated to the 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. Pharmanewshq.com is the only website focusing specifically on issues relevant to pharmaceutical professionals working with technology, be it development, engineering, IT or production.


    Colorado Bioscience

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

    As champions for life science in our state, Colorado BioScience Association leads expansion policies to advance the industry and accelerate growth. We support a thriving bioscience sector by connecting innovators to funding, infrastructure, research and talent. CBSA fosters bioscience workforce and leadership development through opportunities for networking and professional education.


    Technology Networks

    Official Media Partner
    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


    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

    Media Partners


    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.


    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.


    Samedan

    Supporters
    http://www.samedanltd.com/magazine/13.

    International Clinical Trials (ICT) is a quarterly magazine edited by Dr Graham Hughes, and written by specialists at the forefront of clinical research. ICT’s coverage of operational developments ranges from adaptive designs in early phase trials through to post marketing research. ICT’s targeted readership consists of key decision makers across the pharmaceutical and biotech industries, along with contract partners and consultants. The magazine is distributed to pharmaceutical professionals in Europe and North America, and is accessed globally online. Read the latest issues, explore the ICT archive and subscribe at www.samedanltd.com/magazine/13.


    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


    MDPI Biology Journal

    Supporters
    http://www.mdpi.com/journal/biology

    Biology (ISSN 2079-7737, http://www.mdpi.com/journal/biology) is an international, peer-reviewed, quick-refereeing open access journal of Biological Science. This journal is supervised by Editor-in-Chief, Prof. Dr. Chris O'Callaghan and Associate Editor, Prof. Dr. Jukka Finne. Biology is supported by an outstanding Editorial Board which includes a 2002 Nobel Laureate as well as other excellent scientists (http://www.mdpi.com/journal/biology/editors/). Biology is indexed by PubMed, Zoological Record, Scopus, etc (http://www.mdpi.com/journal/biology/indexing).


    IPI

    Supporters
    http://www.ipimediaworld.com

    IPI – International Pharmaceutical Industry Established by professionals with over 30 years experience in the Pharmaceutical and Life sciences publishing sectors. We have identified the needs of these dynamic industries, and have listened carefully to our readers and advertisers. With strong collaboration between Pharmaceutical and Life sciences Industry Associations we have created a global distribution network. We give you a promise to become a reliable extension of your marketing and communication arm. If necessary we will integrate our expertise with your needs. Incorporating new and innovative communication methods we will help to highlight your expertise.


    Biosave

    Supporters
    http://www.Biosave.com

    Biosave.com brings together the best Life Science promotions, product releases, featured products, publications, videos and events from 100’s of leading Life Science suppliers. Updated 24 hours a day, Biosave is constantly uploading special promotions and exciting product news that you won’t find anywhere else. Our goal is to provide our users with the most exclusive product information to help reach that all important purchasing decision.


    Swiss Biotech Association

    Supporters
    http://www.swissbiotech.org/

    The Swiss Biotech Association (SBA) is the national industry association for biotechnology, including pharmaceuticals, diagnostics, agriculture, food, cosmetics, environmental biotechnology, and specialty chemicals. Members are companies active in modern biotechnology, such as R&D, Production, Marketing and Sales, Finance, Services and Consulting. SBA provides a networking platform for Life Science clusters, academic and federal institutions the like. Founded in March 1998, the Association grows steadily.


    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


    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


    Absave

    Supporters
    http://www.absave.com

    Absave.com is the leading savings website for Antibodies and Immunological Products. Search our extensive database of Antibodies, Kits, Proteins & Peptides, Reagents, etc. to find the best savings!


    Drug Target Review

    Supporters
    http://www.drugtargetreview.com

    Drug Target Review’s quarterly magazine, website and annual events program provides high quality content with peer-written articles that are submitted exclusively by the world’s most respected scientists in their field. This attracts a committed base of readers, users and delegates made up of senior decision-makers from the life science and drug discovery industries at the top pharmaceutical companies, as well as academics and scientists from the top research institutes across the globe.


    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!


    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.


    CanBiotech

    Supporters
    http://www.canbiotech.com

    CanBiotech - A Portal and B2B Outsourcing Marketplace for the Biotech and Pharmaceutical Industry. The Marketplace features the Outsourcing Services Showcase; the Portal features our biopharmaceutical and venture capital directories and databases. Publications include the BioMedical Outsourcing Report and the Bio Outsourcing Asia© Publication.


    Gate2Biotech

    Supporters
    http://www.gate2biotech.com

    Gate2Biotech is a portal that unites biotechnological community in Central Europe. It covers all the news in the field of biotechnology. Thanks to the the portal the companies engaged in the field can easily search for research institutions and other partners to solve technical problems they are facing and here they can also present their services offer to potential partners from the Czech Republic and abroad. Gate2Biotech portal serves as a bridge connecting scientific and commercial sector. It incorporates offices and support organizations dedicated to promoting transfer of innovative technologies into a unified communication platform of Czech and international biotechnologies. As a mediator of information it draws attention to biotechnologies and support of their application and transfer into practice. It also functions as a tool for encouraging non-professionals (especially scientists and students) towards innovative business or applied research.


    Pharmavision

    Supporters
    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.


    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.


    Inderscience Publishers

    Supporters
    http://www.inderscience.com

    Inderscience is a dynamic, leading, independent journal publisher. The company disseminates the latest research across the broad fields of science, engineering and technology; management, public and business administration; environment, ecological economics and sustainable development; computing, ICT and internet/web services, and related areas. Inderscience offers over 35 years' experience in publishing and has succeeded in building a substantial collection approaching 400 high-quality peer-reviewed international research journals in both online and print formats. We offer a variety of ways to keep up-to-date with the latest published leading-edge research while our online collection represents a fully-searchable digital archive of around 60,000 articles.


    SelectScience

    Supporters
    http://www.selectscience.net/register?utm_source=Media-Partner&utm_medium=Website&utm_campaign=SMI

    SelectScience is an independent, online information resource for the worldwide scientific community, and the home of trusted information for laboratory scientists. Discover the latest drug discovery and development technologies, products and techniques with product reviews, videos, application notes and news articles. Become a member for free today.


    Labsave

    Supporters
    http://www.labsave.com

    Labsave is the leading savings website for Laboratory Equipment and Lab Supplies. We work closely with the top suppliers in the world to bring you the best products at the most competitive prices. We are constantly striving to secure the biggest and most exclusive offers that you won’t find anywhere else! http://www.labsave.com/


    evvnt Ltd

    Supporters
    http://www.evvnt.com

    evvnt enables people all over the world to fill their events utilising the most effective event listing sites on the web. Every minute, with little more than a click, more events and conferences appear in listings, in search engines and on mobile - discoverable by both category and location. With next to no effort customers of evvnt get better attendance, while consumers find events they previously had no idea existed. To date customers in 70 countries worldwide have submitted over 500,000 thousand event listings, created over 300,000 live links, and generated 1 million clicks to ticketing and registration pages. Learn more at www.evvnt.com


    EIN News

    Supporters
    http://www.einnews.com

    EIN News is the world leader in industry focused online news monitoring. Thousands of leading companies, institutions and global professionals from business, industry, and government rely on EIN News as an indispensable resource. Our systems continuously scan the web, indexing news from thousands of worldwide sources. The news you need is then organized by advanced software systems managed by a team of professional news editors. Everything we do is focused on streamlining your news searches and research in order to save you time and money.


    Pharmaceutical-Review

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

    Pharmaceutical-review.com is part of Integrated IQ technologies Private Limited(IIQ). A Leading platform for all the Pharma manufacturing companies and buyers across the world.Having a subscriber database of more than 120,000 globally helping the clients to reach their target buyers through our exclusive listing, branding(banner advertisement), e-news letters, e-mail marketing, product reviews, product launch promotions, event marketing, search engine marketing and social media marketing services.


    European Pharmaceutical Review

    Supporters
    https://www.europeanpharmaceuticalreview.com/

    European Pharmaceutical Contractor (EPC) is a quarterly publication dedicated to the international pharmaceutical contract market. Since its establishment in 1997, EPC has provided coverage of technical, strategic and regulatory developments within the industry. The magazine features in-depth opinion-led articles, reviews and interviews, on topics including drug development, outsourcing, pharmacovigilance, partnerships and eClinical management. Read EPC in print, online, or via the Samedan app.

    Crowne Plaza San Diego - Mission Valley

    2270 Hotel Circle North
    San Diego 92108
    USA

    Crowne Plaza San Diego - Mission Valley

    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.