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