Pharmacovigilance: Patient safety

– Role of the distributor and Marketing Authorization Holders
– The importance of collaboration

Falsified Medicines Directive (FMD)

– How we deal with alerts

– How we work with improving quality on both the industry and end-user side

– What are the learnings from implementing the FMD in Denmark?

– What is the current status working with the FMD and what is currently in focus for the Danish Medicine Verification Organization?

– Future changes and development

The European Medicines Verification System (EMVS) has been up and running since 2019 when the FMD became effective. The digital development provides for more data available in the supply chain, which brings both challenges and opportunities.

The Danish Medicine Verification Organization (DMVO) will share learnings and experiences from the Danish national organization, provide an update on current developments, as well give a perspective on what could be seen in the future for the verification system.

The responsibility of MAH: requirements for GMP and GDP oversight

European Shortages Monitoring Platform – how will it impact the industry?

– What is the ESMP and how will it work?

– How will this new initiave impact pharma industry and supply chain?

– When is the platform coming live and how can the industry start preparing? What parts of the company will it involve?

– Will the ESMP replace national initiatives? How can companies and national authorities interact around the ESMP?

– How can the ESMP be set up on time with the right quality?

– EFPIAs/MfE initiative to use EMVS (European Medicinces Verification System) in connection to the ESMP.

Véronique Davoust has over 20 years experience in the pharmaceutical industry, both in Regulatory Affairs and Manufacturing, for Pfizer Inc. In her current position she is responsible for the monitoring and analysis of global and European emerging regulations and guidelines that impact manufacturing sites, especially focussing on Good Manufacturing and Distribution Practices, security of the supply chain, product shortages, serialisation and registration of the Quality section of Marketing Authorization dossier throughout the product life cycle. Furthermore, she ensures the communication and implementation of the guidelines and regulations within the firm, as well as the coordination of responses to competent authorities.

She is deeply involved in Trade Associations activities (eg. European Federation of Pharmaceutical Industries and Associations (EFPIA) or the French LEEM), serving on leadership teams in quality or supply chain. She currently supports the development of EMA’s European Shortages Monitoring Platform (ESMP) as Efpia’s subject matter expert. Véronique is a pharmacist and earned a Doctorate in Pharmacy at the University of Rouen in Normandie, France, and is based in Paris.