NSF to host Pharmaceutical Legislation Update in Manchester and Amsterdam

The one-day 'refresher' course covers Brexit and the legal and regulatory environment of the pharmaceutical industry during a period of unprecedented change

Designed for the busy Qualified Person or pharmaceutical quality professional, the Pharmaceutical Legislation Update will provide updates on international pharmaceutical laws, regulations and guidance.

Pete Gough will host the course in Manchester on 19 March and again in Amsterdam on 21 March 2019 to ensure the pharmaceutical industry remains compliant.

Mr Gough, Executive Director of Pharma Biotech, has more than 40 years' experience in the pharmaceutical industry and has been responsible for advising senior management regarding changes to pharmaceutical legislation and guidance for the past 15 years.

Topics discussed will include:

  • Brexit and guidance from the EMA and the UK government
  • New separate EU GMP legislation for marketed and investigational products linked to the implementation of the CT Regulation
  • The implementation for 'Safety Features'
  • 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

Discounts are offered to NHS staff, regulators and charities and for companies sending more than one delegate.

To ask a question about the course, contact pharmacourses@nsf.org.

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