To be released – Clinical Trial Application and Investigational Dossier

150,00 

An explanation on the Clinical Trial Application (CTA) procedure with the types of documents and information to be included. The implications of the new Clinical Trials Information System (CTIS) and the content of the CTA, the Investigational Medicinal Product Dossier (IMPD) and Amendments on these documents.

Available on backorder

Description

Who should attend this course?

This training course is designed and targets a diverse range of professionals with specific expertise in the field of ATMPs than want to know more about the development process of these products.  The course is specifically focus on:

  • ATMP Manufacturers and Commercialization
  • CMC Development
  • Process Development
  • Clinical Research Specialist
  • QC and Stability
  • Laboratory Managers
  • Regulatory Affairs Department
  • Scientits and Researchers
  • Healthcare Professionals
  • Industry Professionals and Entrepreneurs

 

TRAINERS

Marían Reviriego, Ex-Regulator at the Medicine and Healthcare products Regulatory Agency (MHRA) in the UK as a Pharmaceutical Assessor or registration dossiers.

She has also worked at various Pharmaceutical and Biopharmaceutical Companies: Pharma Mar, Chemo and finally at TiGenix (currently Takeda), as Regulatory Affairs Head for Cell Therapy Products. Within TiGenix she was part of the team that obtained the first EU Marketing Authorization for an Allogeneic Cell Therapy product (Alofisel).

In 2019 she established herself as a regulatory consultant (Revio Pharmaceutical Consultants, Alladvice Regulatory Consultants) focusing on the field of registration of Chemicals and Biologicals. In addition, she has teaching experience and teaches in Pharmaceutical Industry Master.

DURATION

1 hour