Regulatory Reliance Tools Unveiled: A Practical Guide by EMA Virtual event

Virtual event  |  19 March 2024

09:00-10:30 BTZ  -  13:00-14:30 CET  -  20:00-21:30 SGT


In this webinar participants heard from EMA speakers about their assessment outputs for centralised procedures, including European marketing authorisations, post-approval changes, and GMP inspections. Key topics included the drafting of assessment reports, eCPPs (electronic Certificates of Pharmaceutical Product), and other pivotal documents. The aim was to facilitate reliance on EMA as a trusted Regulatory Reference Authority, with the overall objective of striving for process efficiency and sustainability. 

This webinar was intended for professionals from regulatory bodies, the pharmaceutical industry, and academia who wished to learn more about EMA’s assessment process and how it can be leveraged for reliance.


Why joining this webinar:

  • Insightful Presentations: EMA offered insights into their centralised assessment process and documentation outputs.
  • Exploration of Assessment Outputs: Discover the purpose, content, and practical use of EMA's assessment documents for the purpose of  regulatory reliance mechanism.
  • Interactive Q&A Session: Audience's questions were addressed directly by our experts during the webinar, including representatives from the EMA, WHO, and other global regulatory authorities.


Confirmed speakers included:

  • Tom Brusselmans, Scientific officer, Inspections Office, EMA
  • Agnes Chan, Director of the Therapeutics Product Branch, Health Sciences Authority, Singapore
  • Alberto Gañán Jiménez, Head of Committees and Quality Assurance Department, EMA
  • Asmaa Fouad, Head of Central Administration of Biological & innovative products & Clinical trials at EDA, Egypt and representative of EDA in ICH. Advisory member of ECBS-WHO
  • Martin Harvey Allchurch, Head of International Affairs, EMA
  • Victoria Palmi Reig, Senior International Affairs officer, EMA
  • Virginia Rojo Guerra, Head of Procedures Office, EMA
  • Marie Valentin, Team Lead, Facilitated Product Introduction, Regulation and Prequalification Department, World Health Organisation

With introductory remarks from Emer Cooke, Executive Director, EMA.


Watch the event recording