Dr. Thomas Lönngren, Strategic Advisor to NDA Group and former Executive Director of the European Medicines Agency (EMA), has been invited to present at the Chief Medical Officer Summit, Omni Parker House, Boston, MA on 7th May.
Thomas will present along with Jeffrey Sherman, CMO, EVP R&D, Horizon Pharmaceuticals, in the session ‘Taking a Strategy Approach to Global Regulatory and Market Access Challenges’, were they will discuss:
- Is a global regulatory and market access strategy the way to go?
- Why isn’t EMA approval the same as market access in Europe?
- What is the difference between EMA and FDA in regulating and approving medicines?
- When and how to generate evidence that will satisfy regulators and payers
- What is the best strategy to interact with regulators and payers?
- Early access schemes in EU and how to qualify
- How will trends like Real World Evidence influence regulatory decision making?
- Brexit and its consequences for the EU regulatory system and how will it affect pharmaceutical companies
As well as presenting at the event, NDA Group is ‘Associate Sponsor’ of the CMO Summits, demonstrating its commitment and support towards the CMO community.
Please come by booth #2 and meet us;
- Dr. Thomas Lönngren, Strategic Advisor to NDA Group and former Executive Director of the EMA
- Laurie Smaldone-Alsup, MD, COO/CSO
- Barbara Clendenen, Director, Business Development
The CMO conference is an annual gathering for physicians and scientists in biotech to exchange best practices in the advancement of drug development and business management. Although the program is primarily designed for CMOs of emerging biotech companies, CMOs of large pharma and other R&D decision-makers will also benefit.
To find out more about the event click here.