Welcome to the sixth TOPRA Annual Symposium, this year in Stockholm!

Introduction

The theme of this year’s symposium is European Regulatory Affairs in a Global Environment. We will explore the current challenges and opportunities in the European regulatory system and see how these processes interact and link into the Global regulatory environment. The world is getting smaller! It is clear that both industry and agencies need to think and act in a global arena.

For this year’s symposium programme, we have been working closely with the Medical Products Agency in Uppsala. With their help, and the hard work of the TOPRA symposium organising committee, I am proud to say that you have in front of you a very interesting programme, which will be presented by highly respected speakers, including representatives from the European Commission, EMEA, FDA, national Competent Authorities and Notified Bodies, and industry pharmaceutical and device companies, large and small.

The Main Symposium programme includes sessions on:

• Best practice on the use of Centralised Procedure for Marketing Authorisation (in the European Union - covering the critical and practical success factors for obtaining marketing authorisation in the EU.
• Advances Therapy Medicinal Products/CAT - reviewing the experience of implementing the new Regulation, in force since December 2008.
• Combination Products (drug-device) – considering their increasing regulatory challenge for industry and regulators.
• Pharmacovigilance - discussing some of the regulatory paradigms of pharmacovigilance in comparison to their real value for public health.
• Paediatrics – looking at the experience gained from having had the paediatric regulation in place for more than two years.
• Pharmaceutical Clinical Trials in the Global Environment - considering the challenges posed by conducting global clinical trials.
• Globalisation - discussing the Drug Development World outside the EU, and its opportunities and challenges.
• European Union – latest news - including the status of the European Commission’s Pharmaceutical Package, the Road Map of the EMEA and the implementation of the Heads of Medicines Agency (HMA) strategy paper.

Parallel breakout sessions will cover:

• Electronic Regulatory Affairs: Are we ready for 1 January 2010?
• North America: Hot topics at the FDA
• CMC: Variations
• Regulatory Careers

Thursday will include as previous years two parallel symposia:

The Medical Device Annual Symposium will cover:

• Combination Products
• Borderline and Classification Issues
• Implementation of Directive 2007/47/EC
• What Does the Future Hold?

The Veterinary Annual Symposium will cover:

• Opportunities for a reorganisation of the regulation of veterinary medicines in Europe
• Outcomes of recent joint focus group meetings and workshops
• CMDv initiatives – bringing efficiencies to the system
• Better regulation

SME Day

For the first time we are also proud to include a SME Day as part of the symposium. Wednesday morning will give delegates from small and medium-sized enterprises (SME) the opportunity to understand regulatory challenges specific to them. The support provided by the SME office at the EMEA will be explored, and experiences by SME companies shared. The rest of the day will be common to the main symposium.

This is your chance to interact and network with your regulatory colleagues and to discover and explore the Nordic Venice of Europe.

I look forward to seeing you in Stockholm in October.

Margareth Jorvid, chair of the TOPRA symposium organising committee