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?
- Regulatory implications of various changes in the legal and operational environment
- Electronic submission environment
Romuald Braun and Bernard Ferber at AMPLEXOR's booth