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Are you keeping up to date with changes to pharmaceutical laws and guidance?

The legal and regulatory environment affecting the pharmaceutical industry is in a period of unprecedented change. Are you keeping up with all these changes?

• Brexit is very close, with massive implications for pharmaceuticals being reflected in guidance from both the EMA and the UK government
• New, separate EU GMP legislation for both marketed and investigational products linked to the implementation of the CT Regulation
• The implementation for ‘Safety Features’ is upon us
• A new regulation for medical devices which will have a significant impact on combination products
• Implementation of the MRA between the EU and the USA
• 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 with in the US FDA
• The FDA implementing new inspections protocols for aseptically produced products

To say current come to Pete Gough’s Pharmaceutical Legislation Update day in either Manchester, UK, on 19 March or Amsterdam 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.

Pharmaceutical Legislation Update – 19 March, Manchester, UK

Pharmaceutical Legislation Update – 21 March, Amsterdam, Netherlands Have a question? Contact our friendly team at
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