Take a look at whats new for Filing Variations 2012

• 13 industry presentations delivered by regulatory experts from leading pharmaceutical companies
• 9+ hours of networking with senior regulatory affairs professionals
• Practical advice on how to determine implementation dates, use annual reporting and manage a variation in eCTD.
• Industry case studies examining experiences of the 1234/2008 guideline including overcoming the hurdles of grouping variations and worksharing
• Learn how to use the article 5 procedure and handle variations via the MRP procedures
• Expert advice on how to prepare for the implementation of article 57 and XEVMPD

Tuesday 8^th May: Pre-conference Workshop

** Includes networking dinner**

Advanced training in regulatory strategy for filing variations

• Salma Michor, Chief Executive Officer & Principal Consultant, Michor Consulting EU, Austria

The evening briefing will focus on strategising variation procedure in order to develop a more efficient and fail-safe system. This unique problem-based learning session will encourage delegates to discuss regulatory strategy and share experiences, whilst generating solutions with industry peers before reassembling to examine their findings.

Wednesday 9^th May: Evening Seminar S

**Includes networking dinner**

Addressing inter-agency discrepancies and working towards harmonization for 1234/2008

• Keith Pugh, MHRA Licensing Division Expert Assessor, MHRA, UK
• Margarida Oliveira, Head of Post Marketing Authorisation Unit,  Infarmed, Portugal
• Igor Popovic, Medicines and Medical Devices Agency, Serbia

An indispensable opportunity to interact with regulators and industry practitioners as they address and discuss the differences in filing variations across Europe’s National Procedures.

The evening seminar will consist of two presentations examining the challenges faced by a large regulatory authority Vs a small regulatory authority with regards to 1234/2008. This will be followed a regulator’s discussion panel and networking dinner.