The Eighth International Pharmaceutical Compliance Congress and Best Practices Forum will take place May 5-7, 2014 in Dubai, UAE. US stakeholders who can’t make the overseas trip can watch anytime within 6 months following the conference. We will be providing extensive coverage of the conference here on Policy and Medicine.
This conference began in June 2007 in Brussels as a way to bring together company compliance professionals, regulators, lawyers, and consultants. International conferences have since been held in Paris (2008), Rome (2009), Berlin (2010), Istanbul (2011), Budapest (2012) and Madrid (2013). Over the years the international conference agendas have developed to focus particular streams on the European Union (EU), Central and Eastern Europe (CEE), and Middle East and Africa (MEA), in addition to plenary sessions on global topics.
This year, the Eighth International Compliance Congress will address the leading pharmaceutical and medical device ethics and compliance issues in the EU, and include updates from CEE, MEA, and India.
The session entitled “Global Transparency Regulatory Update Roundtable” may be of particular interest. This presentation offers perspectives from many countries working under the EFPIA Code, which we have written more about as the Sunshine Act has gone global. Speakers from Denmark, France, Germany, Spain, and the UK will offer their Best Practices in this increasingly important area. “US Sunshine Act Update and Brief Reports on Asia Pacific and Latin American Transparency Initiatives” also promises to provide useful information about transparency laws in emerging markets.
The Conference will cover:
Changing Business Models:
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Context:
- Rising Costs
- Decline of Blockbuster Model
- Rise of Specialty Care/Biologics
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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
We think this conference will provide useful information for compliance and legal departments looking to navigate the international healthcare landscape. For more information about the specific speakers, and on how to register, click here.