15th EGA Regulatory and Scientific Affairs Conference

28 January 2016

Meeting the Future Challenges and Opportunities in the Regulatory Environment.

15th EGA Regulatory and Scientific Affairs Conference had offered an update on recent regulatory developments, and answered the following answers:

  • Looking to the future- EMA/HMA Strategy 2020 Work Plan- how will it impact the regulatory environment for pharmaceuticals?
  • Tackling effects of the globalisation of pharmaceutical operations – challenges, opportunities and priorities
  • Maintenance of medicinal products: is there a better way of handling it in practice?
  • Borderline medicinal products - Do on-going changes to medical devices, food supplement legislations impact my products?
  • How does the ICH 3QD guideline on elemental impurities affect my products?
  • ISO IDMP is around the corner: are we set and ready to start with implementation?

Key Takeaways

  • Regulatory implications of various changes in the legal and operational environment
  • Electronic submission environment


Romuald Braun and Bernard Ferber at Amplexor's booth