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17-19 May 2022
Steigenberger Wiltcher's, BrusselsBrussels

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:

  • EU Commission on Pharmaceutical Strategy for Europe
  • EMA and industry leaders on how to convert COVID-19 flexibility to “fit for innovation” regulations
  • Beneluxa Initiative on joint procurement alliances a discussion, joint HTAs, and joint negotiations
  • MHRA on the Northern Ireland Protocol and UK regulations in national, European and Global contexts

Deep Dive into the Hottest Regulatory Topics on:

  • IP regulatory rights for Paediatric and Orphan Medicines from Amgen
  • Real-World Evidence in practice from Gilead Sciences
  • Challenges for combination products and companion diagnostics with GSK 
  • New technology to support patients  including telehealth and AI with Novo Nordisk A/S
  • Risks for digital interactions with HPOs, HCPs, Patient Organisations, and Patients with Intercept Pharmaceuticals

Get Involved with 2 Live ATMP Focused Workshops:

Think tank session on Sameness / 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 on Market 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

Deputy Head of Unit

European Medicines Agency

Head of Pharmaceutical Law

Medicines and Healthcare products Regulatory Agency

Director of Policy

National Institute for Health and Disability Insurance (NIHDI RIZIV/INAMI)

Head, Directorate Reimbursement of Medicines and Pharmaceutical Policy

Beneluxa Initiative

Country Co-ordinator for Belgium

European Medicines Agency

Head of Litigation Office