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overview
Key Learning Objectives
Regulatory Affairs for Europe
- Overview of regulatory bodies & competent authorities; EU legislative systems
- Clinical Trial regulations (data requirements, IRB; CTR 2014, ICH GCP; differences within EU)
- Clinical Trial Approval Process
- Product Development regulations (Non-clinical studies vs Clinical studies)
- CTD and eCTD
- Labelling and packaging regulations
- Marketing Authorisation Applications (CP, DCP, MRP, National Procedures)
- Post-MAA obligations, Pharmacovigilance and lifecycle management
- Understanding abridged applications
Case studies: biosimilars, oncology, OTC, generics
- Working effectively with EMA
- Legal issues (product recalls, CT violations, data manipulations, data privacy etc)
About the Course
In the heavily regulated, rapidly changing environment, staying informed with requirements and guidelines maintained by different authorities is crucial to pharma/biotech players. Complex and challenging, the success in clinical approvals, dossier submission, pharmacovigilance, product filing, among other operations, allow you to accelerate market access and achieve bottom line.
This live-online masterclass explores key touchpoints across European regulatory systems. The training offers attendees an indepth examination into latest regulatory reforms, legislative developments, including data privacy, labelling & packaging, post-MAA obligations, import & manufacturing registrations, fast-track approvals, as well as key legal issues.
Course Outline
Overview of EU Regulatory Framework
- Regulatory Bodies and Competent Authorities
- Legislative system
- EU pharma law
Product Development – Non-Clinical Studies
- The Target Product Profile
- Non-clinical development
- Toxicology
- Pharmacokinetics and toxicokinetics
- Environmental risk assessment
Product Development – Clinical Studies
- Clinical trial directive
- Regulations
- Ethics Committees, IRB
- Data requirements
- CTR 2014
- ICH GCP
- Difference between EU countries
- GCP
- Data protection
Marketing Authorisation Application
- Regulatory Procedures
- Centralised procedure & decentralised procedure
- Mutual recognition procedure
Case studies: Orphan drugs, advanced therapies, etc - Scientific advice
- Registration dossier
- GxP and MA dossier
- CTD and eCTD requirements
- CMC module
Labelling & Packaging Requirements
- Packaging & labelling guidelines
- Patient information leaflets PILs in Europe
- SmPC
- Serialisation of Pharma Folding Cartons
- Track-and-trace solutions
- Readability guidelines
Post-MAA: filing variations and renewals
- Introduction to filing variations
- Variations requirements and procedures
- Compare the different types of variations: Type IA, IB, and II
- Variations vs extensions
- Renewal legislation and procedures
Pharmacovigilance Obligations
- Good pharmacovigilance practices
- Periodic safety update reports (PSURs)
- Risk management plan and post-authorisation safety studies (PASS)
Practical Considerations
- Working effectively with EMA
- Understanding abridged applications
- Legal issues
On-site & in-house training
Deliver this course how you want, where you want, when you want – and save up to 40%! 8+ employees seeking training on the same topic?
Talk to us about an on-site/in-house & customised solution.
contact
Still have a question?
Sushil Kunwar
Training Consultant
+61 (0)2 9080 4395
training@informa.com.au