International Pharmaceutical Compliance Congress and Best Practices Forum


Timothy Ayers, Christine Bradshaw and Brian Sharkey spoke at the 8th Annual International Pharmaceutical Compliance Congress and Best Practices Forum in Dubai, United Arab Emirates on May 5-7, 2014.

Chrissy and Brian co-moderatedĀ the Mini Summit V: Advanced Issues In Global Transparency, Disclosure and Aggregate Spend Compliance panel on Tuesday, May 6.

Tim spokeĀ on the Mini Summit XVI: Practical Approaches To Managing The Compliance Function Being Both Small and Global panel on Wednesday, May 7.

The 8th International Pharmaceutical Compliance Congress and Best Practices Forum addressed leading pharmaceutical and medical device ethics and compliance issues in the European Union (EU) and include updates from Central and eastern Europe (CEE), the Middle East and Africa (MEA) and India. The Congress focused on the following New Business Models and New Compliance Challenges:

Changing Business Models:

- Context:
  • Rising Costs
  • Decline of Blockbuster Model
  • Rise of Specialty Care/Biologics
- Industry Trends:
  • Consolidation
  • Patent Cliff
  • Mature Markets
  • Growth of Emerging Markets
  • Diversification into Diagnostics and Devices, Generics and Consumer Health
  • More Partnerships, Collaborations, and Licensing Agreements

- Old Model Centered on Company/HCP Relationship
- New Model in US, ACA, Increased Governmental Funding and Negotiations with Insurers
- New Model Globally, Negotiation with Government
- Emerging of Comparative Effectiveness Research

New Ethics and Compliance Issues Arise around:

- Market Access, Affordability, Infrastructure and Knowledge in Emerging Markets, Limiting Health Care Systems
- Managing Third Party Relationships, Increased Risk, Less Transparency
- Pricing and Reimbursement; Conditional upon Post Marketing Confirmation of Effectiveness
- Tendering
- R&D; Clinical Trials; Publications
- Medical Education
- New National Anticorruption Initiatives
- Proliferation of Transparency Initiatives
- The Role of Compliance Codes

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