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EU Pharmaceutical Law Forum
Hybrid Event | 23 - 25 May 2023
Steigenberger Wiltcher's, Brussels

Hybrid Event | 23 - 25 May 2023
Steigenberger Wiltcher's, Brussels

Wednesday 24 May 2023

Regulatory Frameworks: Implications of Legislative Revision and Market Access Pathways

Prepare For The Impact Of The Biggest Shake-Up Of Pharmaceutical Policy And Legislation With The EU Commission, European Medicines Agency (EMA), And Key Pharmaceutical Stakeholders

Benchmark Your Regulatory Legal Progress With Real World Insights On Key Pharmaceutical Legal Issues:

Industry Impact the EU Pharmaceutical Legislation Revision:

  • Novel Incentives: Vouchers And Beyond - What Is Needed?
  • Examining Proposed Changes To The Paediatric Regulation
  • New Updates On Regulatory Data Protection
  • Changes To Orphan Market Exclusivity

New Developments in Regulatory Frameworks:

  • Legal Requirement And Obligations For Your Supply Chain
  • Reshaping Clinical Research With Health Data
  • Using IVDs In Clinical Trials - How To Ensure Compliance
  • Artificial Intelligence Act And New Rules Surrounding AI Liability Directive

Evolving Pharmaceutical Market Access Frameworks:

  • Examine EU Joint HTA processes and the interaction with national EU processes
  • Will faster marketing authorizations lead to faster reimbursement?
  • Ilap: new market access pathway in the UK
  • Innovative healthcare systems solutions and market access strategies