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

Virtual event  |  19 March 2024

09:00-11:00 BTZ  -  13:00-15:00 CET  -  20:00-22:00 SGT

 

You are invited to a webinar where you will hear from EMA speakers about their assessment outputs for centralised procedures, including European marketing authorisations, post-approval changes, and GMP inspections. Key topics will include the drafting of assessment reports, eCPPs (electronic Certificates of Pharmaceutical Product), and other pivotal documents. The aim is to facilitate reliance on EMA as a trusted Regulatory Reference Authority, with the overall objective of striving for process efficiency and sustainability. 

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

 

Why should you join this webinar:

  • Insightful Presentations: EMA will offer 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: Have your specific questions addressed directly by our experts during the webinar, including representatives from the EMA, WHO, and other global regulatory authorities.

 

Confirmed speakers include:

  • 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 and Clinical Trials, Egyptian Drug Authority
  • 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

 

The webinar will be conducted in English, with translations provided in French, Portuguese, and Spanish.

All participants are invited to register in advance using this link to join the webinar.

We look forward to seeing you online!