During this course you will get an advanced introduction and insight in the challenging environment of EU regulatory legislation and practical advice for work in the future. In addition, an update on the latest developments and impact on the daily activities of a pharmaceutical company will be provided.
As a result of the training you should be able to avoid pitfalls and compliance issues with the latest European regulations and optimize the effectiveness of your Pharmacovigilance system.
To whom it may concern
- Regulatory Affairs Manager, Officer and Specialist
- Quality Manager
- Development Pharmacist
- Pharmacovigilance Manager
- Project Manager
working for pharmaceutical company and CROs.
Review European Regulatory Affairs legislation
- Managing strategies based on to European regulatory affairs
- Understanding the new regulatory procedures – What’s new in Regulatory Affairs?
– Transparency policy
– CTA and Clinical data entry (EudraCT)
– PRIME / adaptive licensing
– ISO IDMP
– Falsified Medicine Directive and impact on RA
- EU procedures, CMDh guidance and Q&A documents:
– National / MRP/ DCP / CP
- Advanced RA in EU:
– Orphan Drug Designation
– Pediatric Investigation Plans
– Scientific Advice / protocol assistance
– IMPD / IB
– ATMPs: Cells, tissues, organs, gene therapy, cloning
- Electronic Submission in EU
eCTD / NeeS
CESP / Gateway
xEVMPD / ISO IDMP
Participants need to have a basic understanding of EU regulatory procedures.
Type of Training
Presentation, including practical session of business cases and questions from audience
At the end of the training, you will be able to:
understand the complex EU legislation and requirements and increase your knowledge of the latest developments in order to ensure compliance in future.
Lidia Canovas, Director of Regulatory Affairs, Asphalion S.L.
Lidia has a Pharmacy and MBA degree. She has fifteen years overall experience in pharmaceutical industry, ten years as Regulatory Affairs Director and four years as Vice-Director for Research and Development.
She has been working at Asphalion for ten years as General Manager and Director of Regulatory Affairs. As director of Regulatory Affairs at Asphalion, Lidia is responsible for the overall quality of the Regulatory and Scientific services that Asphalion provides to a large number of international and national clients.
Remco Munnik, Regulatory Information Director, Asphalion S.L.
Remco has a Bachelor degree in a study of Management, Economics & Law. He has over fifteen years’ experience in submission procedures EU/US, electronic submission and regulatory data management. Since 2011 Remco works for Asphalion, an international Regulatory Affairs consultancy, based in Barcelona and Munich. Within Asphalion, Remco is responsible for global eSubmission projects (eCTD, NeeS, RIM, xEVMPD and ISO IDMP). His team is working on CP/DCP/maintenance for EU and FDA (IND/NDA/BLA/maintenance). In addition a dedicated team is focussed on xEVMPD submission and IDMP implementation. In addition he is the chairman of Medicines for Europe Telematics working group and in direct contact with EMA and NCAs for the eSubmission roadmap, eCTD specification, validation criteria, eAF, CESP, Gateway, xEVMPD and ISO IDMP.