Agenda at a Glance

Main Conference Day One:  Wednesday 24th September, 2014

8.00 Registration

9.00 Chairman’s Comments

9.05 How to Ensure Transparency under the new Clinical Trial Regulation: How will Multinational Clinical Trials be Regulated?

10.40 Aligning Your Regulatory and Compliance Practice with the Upcoming Changes in Clinical Data Requirements for EU Medical Devices

11.40 Pricing and Reimbursement: How to Balance Cost Containment, Pharmaceutical Innovation and Patients’ Access to Medicines

2.00 Overcoming Challenges in Pharmacovigilance Legislation: Accomplishments, Challenges and the Way Forward

3.00 Unravelling the Complexities of Adaptive Licensing: Dilemmas and Best Possible Solutions Explored

4.00 Outsourcing of an API manufacture and Bolar: Review of the Conflicting cases in Europe and What Companies Need to Know about the Bolar Exemption and Third Parties

4.45 Regulatory Insight and Industry Perspectives on your Biosimilars Strategies

5.30 Chairman’s Closing Remarks and End of Day 1

Main Conference Day Two: Thursday 25 September, 2014

8.30 Registration

9.00 Chairman’s opening remarks

9.05 Competition, Anti-Trust and Pharma Patents: Protect Your Intellectual Property in light of the Recent Case Law

11.00 What Do You Need to Know about Abuse of Dominance and Patent Settlement Cases?

12.00 Collaborations, Co-Promotion and Co-Marketing:  Minimising Your Competition Law Risks

2.00 Italian Competition Authority v Pfizer (Xalatan) – The Future of Competition Enforcement by National Authorities?

3.00 Decentralisation of Competition Law Enforcement: Understanding of the Main National Decisions

4.00 Chairman’s Remarks and End of Conference