Regulatory Considerations for Advanced Therapies & RNA-Based Therapeutics

Sign in to register as a Member Not a member? Join Today!

Register as a Nonmember

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

Registration Fees & Deadlines

21 November 2021 – 3 May 2022: Early Bird €555 Member | €650 Nonmember

4 May 2022 – 3 June 2022: Regular €650 Member | €770 Nonmember



  • Understand the regulatory and development challenges associated with advanced therapies
  • Identify regulatory pathways for optimization of development plans
  • Gain product type specific insights through case study discussion

Workshop leader

Kirsten Messmer, PhD, RAC

Senior Research Analyst

Agency IQ

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

Cancellation Policy

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. 

All cancellation requests must be submitted in writing via our online cancellation form. RAPS is unable to accept cancellations by phone. Please specify the name of the person registered and event title. 

Substitutions may be accepted with written approval from RAPS and must be submitted to