TOPRA Annual Symposium 2018

1. The latest regulatory updates

Hear leading experts explaining and debating fundamental changes to regulations across the pharmaceutical and medical device/IVD spectrum. Here are just a few of the highlights:

• European Network Strategy: halfway to 2020 – achievements, challenges and obstacles
• Implementation of medical device and IVD regulations
• The new Veterinary Regulation
• Cooperation between medicinal products and medical devices
• Early access schemes, HTA and market access
• International collaborations: the work of ICMRA, EMA collaborations and WHO's 50th anniversary
• Clinical evidence and post-market surveillance under the new MDR
• CT regulation - portal pilot
• Telematics and SPOR
• Advanced therapies for humans and animals
• CMC updates - paediatric formulations and the evolving CMC landscape in China
• Support to SMEs by EMA and case studies

2. Insights from regulators

The TOPRA Annual Symposium is the only conference in Europe of its kind where you will have the chance meet regulators from across the world. This year you can interact with experts from agencies including:

• Swedish Medical Products Agency (MPA)
• Medicines and Healthcare products Regulatory Agency (MHRA), UK
• Veterinary Medicines Directorate (VMD), UK
• Republic of Estonia Agency of Medicines (Ravimiamet), Estonia
• Medicines Evaluation Board (MEB), The Netherlands
• National Agency for Food, Environmental and Occupational Health Safety (ANSES), France
• Agency for Health and Food Safety (AGES), Austria
• Danish Medicines Agency (DKMA)
• Medicines Authority, Malta
• Health Products Regulatory Authority (HPRA), Ireland
• Paul Ehrlich Institute (PEI), Germany
• European Medicines Agency (EMA)
• European Commission

3. Regulatory intelligence

The TOPRA Annual Symposium excels in bringing together innovators and experts from a wide range of organisations. Find out how your peers are tackling the practical issues arising from a changing geopolitical environment and disruptive technological advances, including:

• Brexit: the impact on EMA and other European agencies
• Enhancing product information and opportunity for electronic approach
• IVD performance evaluation and technical documentation requirements
• GDPR and digital health
• Vaccines
• Anti-microbial resistance

4. Professional competence

Make sure to attend at least one session of our professional competencies stream while you are at the Annual Symposium this year. There will be a full programme of activities specifically designed to support you through your career, including:

• Developing regulatory skills and knowledge – apprenticeships and competences
• Managing teams through change
• Certification – demonstrating professionalism and excellence

5. New contacts from across the industry and around the world

Access TOPRA’s worldwide community, with representatives from a wide variety of organisations – from human medicines, veterinary medicines and medical devices.