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This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
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Thursday, 2 June 2022 (2:00 PM) - Friday, 3 June 2022 (6:00 PM) Central European Time
Advanced therapies are one of the fastest growing sectors in the biopharmaceutical industry. A myriad of new and innovative technologies are being developed to treat human diseases which are often rare or ultra-rare. However, these complex technologies entail regulatory challenges at any stage of the product development. Regulatory requirements for quality, CMC, preclinical and clinical research that may differ by jurisdiation add to the challenges of product development. The first day of the workshop will provide an overview of the regulatory landscape for product development considerations and clinical trial conduct in the European Union and the United States. This overview will include discussion of opportunities to interact with regulators and utilize available regulatory tools. The second day will discuss regulator considerations for specific product types based on case studies
21 November 2021 – 3 May 2022: Early Bird €555 Member | €650 Nonmember
4 May 2022 – 3 June 2022: Regular €650 Member | €770 Nonmember
Kirsten Messmer, PhD, RAC
Senior Research Analyst
Kirsten Messmer, PhD, RAC is a Senior Research Analyst and contributes to the research and development of content for Agency IQ. Prior to joining Agency IQ, she was a Principal Regulatory Affairs Specialist at PPD providing global regulatory intelligence to support efficient, compliant and successful clinical research and drug development for biopharmaceuticals and advanced therapies. Kirsten received her PhD in Neuroscience from the University of Sheffield (Sheffield, UK) and a Biology Diplom from the Eberhard-Karls University (Tübingen, Germany). Kirsten also holds a Regulatory Affairs Certification (RAC) in US regulation.
Dr Emil Cochino
European Medicines Agency
Dr Emil Andrei Cochino is a Specialist in Public Health and Health Services Management. He has been a scientific officer at EMA from 2009, and is working in the Human Medicines Department as a Scientific Senior Specialist (Risk Management), where he is responsible for peer-reviewing risk management plans for centrally authorised products (ATMPs and vaccines) and improving the access of ATMPs to the market by supporting the collaboration with the HTA and payers organisations. Furthermore, he has overseen the revision 2 update of GVP Module V – Risk Management Systems and coreRMP19 guidance
RAPS reserves the right to cancel this program at its sole discretion. RAPS will not be responsible for travel or other costs incurred due to cancellation.
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Substitutions may be accepted with written approval from RAPS and must be submitted to firstname.lastname@example.org.