The legal and regulatory environment affecting the pharmaceutical industry is in a period of unprecedented change.
Are you keeping up with all of the following changes?:
- Brexit is very close, with implications for pharmaceuticals being reflected in guidance from both the European Medicines Agency (EMA) and the UK Government
- New, separate EU good manufacturing practice (GMP) legislation for both marketed and investigational products linked to the implementation of the clinical trial (CT) regulation
- The implementation for ‘Safety Features’ is upon us
- A new regulation for medical devices that will have a significant impact on combination products
- Implementation of the Mutual Recognition Agreement (MRA) between the EU and the US
- Changes to the scope of the EU-Japan MRA
- The draft revision of EU GMP Annex 1 on Sterile Products
- Revised versions of EU GMP Annexes 2,13 and 17
- The proposed new EU GMP Annex 21
- The new EU GMP Part IV on Advanced Therapy
- The draft of ICH Q12 on Lifecycle Management
- Proposed revision of ICH Q2 and new ICH Q13 and 14
- Significant reorganisation within the US Food and Drug Administration (FDA)
- The FDA implementing new inspections protocols for aseptically produced products
To stay current, come to Pete Gough’s Pharmaceutical Legislation Update day in either Manchester, UK, on 19 March or Amsterdam, The Netherlands, on 21 March 2019 and make sure that you remain in compliance.
Discounts are offered to NHS staff, regulators and charities and for companies sending more than one delegate.
See these links for more information and to register: