NSF to host Pharmaceutical Legislation Update in Manchester and Amsterdam

Published: 6-Feb-2019
Regulatory Pharmaceutical

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.

  • Companies:
  • NSF
See more

You may also like

Regulatory

NSF International launches two water fitting accreditations

Read more
New REG4 Accreditations to Help Water Fittings Suppliers Rapidly Deliver Products to Market

Trending Articles

  1. Catalent and AstraZeneca to expand support for COVID-19 vaccine AZD1222 Catalent will prepare the Harmans facility, close to Baltimore-Washington International (BWI) airport, to enable multiple production trains to run in parallel to produce the vaccine candidate drug substance commencing late in the third quarter of 2020
  2. Chemistry, manufacturing and control (CMC) as key drivers for drug discovery success Embracing collaborative strategies not only accelerates drug development programmes but also fosters science-based milestone decisions, mitigates risks and prepares for successful market entry from the early stages of development, reports Frederick Duynslaeger, Senior CMC Writer at Ardena
  3. Overcoming CMC challenges in cell and gene therapy: part II Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  4. Overcoming CMC challenges in cell and gene therapy: part I Certara’s Dr Hien Anh Bruno, Associate Director, Chemistry, Manufacturing and Controls (CMC), and Dr Deven Shah, CMC Lead, propose mitigation strategies to address the CMC challenges inherent in producing cell and gene therapy (CGT) drugs
  5. Innovating with purpose for safety and security of outcome Beyond the importance of increasing productivity and generating more output and value with the same input, new ideas and technologies from GEA take innovation a step further

Upcoming event

Cleanroom Conference UK

22–23 May 2024 | Exhibition | Birmingham, UK See all

You may also like

Regulatory

NSF International launches two water fitting accreditations

New REG4 Accreditations to Help Water Fittings Suppliers Rapidly Deliver Products to Market
Regulatory

2022 Pharma Training Courses from NSF

Start your year right and keep your goals on track with NSF’s training and education. NSF's pharma training and education programs focus on changing behaviours at both an individual and organisation-wide level
Regulatory

NSF explains why you might need a remediation program

The team at NSF explores why remediation projects are needed, the traits of successful programs and what to do to ensure success in your remediation efforts
Finance

Remediating pharmaceutical quality systems

Much of our work involves helping companies remediate flawed quality systems. Find out the factors that can make your remediation project a success
Regulatory

Pharmaceutical legislation update subscription service

Sign up for NSF’s September start date
Manufacturing

Big names announced for leading Pharma and Cleanroom conference

The Cleanroom Technology Conference and Manufacturing Chemist Live collaboration will take place on the 10-11 November. Delegate tickets are currently available
Regulatory

White paper: Streamlining Pharma Operations in the Wake of COVID-19

COVID-19 is shedding further light on pharmaceutical sourcing strategies and their inherent complexity, explains Jim Morris
Subscribe now