Regulatory Frameworks
Overcome your Legal Hurdles with Updates from the EU Commission, EMA, MHRA, and Key Pharmaceutical Stakeholders
Benchmark your Progress, Receive Practice Advice and Gain Insight on Key Pharmaceutical Regulatory Issues
Tune in for the Live Sessions to Hear from the:
Tune in for the Live Sessions to Hear from the:
- EU Commissionon Pharmaceutical Strategy for Europe
- EMA and industry leaderson how to convert COVID-19 flexibility to “fit for innovation” regulations
- Beneluxa Initiativeon joint procurement alliances a discussion, joint HTAs, and joint negotiations
- MHRAon theNorthern Ireland Protocol and UK regulations in national, European and Global contexts
Deep Dive into the Hottest Regulatory Topics on:
Deep Dive into the Hottest Regulatory Topics on:
- IP regulatory rights for Paediatric and Orphan Medicines fromAmgen
- Real-World Evidence in practice fromGilead Sciences
- Challenges for combination products and companion diagnostics withGSK
- New technology to support patients including telehealth and AI withNovo Nordisk A/S
- Risks for digital interactions with HPOs, HCPs, Patient Organisations, and Patients withIntercept Pharmaceuticals
Get Involved with 2 Live ATMP Focused Workshops:
Get Involved with 2 Live ATMP Focused Workshops:
Think tank session onSameness / Similarity for Orphan ATMP Products
- EMA discuss the regulatory landscape for assessment of similarity for ATMPs
- Examine the difference between the New Active Substance (NAS)/Similarity assessment
Interactive workshop onMarket Access for Innovative Therapies
- Explore Innovative payment models and structuring contracts
- Comparison of different European national approaches to reimbursing and financing
Authority & In-House Counsel Speakers You Can't Afford To Miss:
European Commission
European Commission
Deputy Head of Unit
European Medicines Agency
European Medicines Agency
Head of Pharmaceutical Law
Medicines and Healthcare products Regulatory Agency
Medicines and Healthcare products Regulatory Agency
Director of Policy
National Institute for Health and Disability Insurance (NIHDI RIZIV/INAMI)
National Institute for Health and Disability Insurance (NIHDI RIZIV/INAMI)
Head, Directorate Reimbursement of Medicines and Pharmaceutical Policy
Beneluxa Initiative
Beneluxa Initiative
Country Co-ordinator for Belgium
European Medicines Agency
European Medicines Agency
Head of Litigation Office
