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Advanced European Regulatory Affairs
Update on Regulatory Affairs developments in Europe and the impact on product development and life cycle management
During this regulatory affairs course you will get an advanced introduction and insight into the challenging environment of EU regulatory legislation and a practical advice for future regulatory affairs projects. 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.
Review of the European Regulatory Affairs legislation
- Managing strategies based on European Regulatory Affairs
- Understanding the new regulatory procedures - What’s new in Regulatory Affairs?
PRIME / adaptive licensing
Falsified Medicine Directive and impact on Regulatory Affairs
- EU procedures, CMDh guidance and Q&A documents:
National / MRP/ DCP / CP
- Advanced Regulatory Affairs 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
Future projects, including review of strategy document
CESP / Gateway
xEVMPD / ISO IDMP
The course will be in English
Lidia has a Pharmacy and MBA degree.
She has more than fifteen years overall experience in pharmaceutical industry, most of which as Regulatory Affairs Director, but she has also covered the role of Vice-Director for Research and Development. She has worked at Asphalion for ten years as General Manager and Director of Regulatory Affairs. In this second role, 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 has a Bachelor degree in Business Administration (Management, Economics and Law). He has over 20 years of experience in Regulatory Affairs, with a special focus on Global submission procedures, electronic submission and regulatory data management. He has been directly involved in the development and roll-out of the EU Telematics environ¬ment and has in-depth knowledge of the systems. Key areas of expertise include Regula¬tory submissions (new MAA to variations), Global eCTD submission, Regulatory Information Management systems (RIM), xEVMPD, ISO IDMP.
The course is addressed to:
- Regulatory Affairs Manager, Officer and Specialist
- Quality Manager
- Development Pharmacist
- Pharmacovigilance Manager
- Project Manager
working for pharmaceutical companies and CROs.
Participants need to have a basic understanding of EU regulatory procedures.
Presentations, including practical sessions of business cases and questions from audience.
Additional information about the venue will be available soon
Early Bird: € 1.670,00* (until 09 April 2020)
Ordinary: € 1.880,00*
Freelance - Academy - Public Administration**: € 990,00*
* for Italian companies: +22% VAT
**Early Bird discount not applicable to Freelance – Academy – Public Administration fee
The fee includes: tuitions, teaching materials, lunches and coffee breaks, organizational office assistance, attendance certificate.
Thursday, April 9, 2020
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 future compliance