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Virtual Event Virtual Event

Regulatory & legal compliance in pharma manufacturing agreements

May 26- 3.00 pm - 4.00 pm

Virtual Event Virtual Event
Pharma manufacturing agreements - 26 May
Pharma manufacturing agreements - 26 May

We are pleased to deliver this webinar in conjunction with PharmaLex, a leading pharmaceutical business consultancy firm.

26 May 2022

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3pm - 4pm

Free

Pharmaceuticals & Life Sciences

Virtual Online Event

Please note: As we are running this webinar jointly with PharmaLex, please be aware that we will be sharing your name, the name of the organisation you work for and your email address with them. Please see our privacy page to find out how we protect and use your data. If you do not want us to share your information with PharmaLex, please let us know by contacting events@vwvplus.co.uk

 

Why attend?

In this webinar, we will cover key issues from both a legal and regulatory perspective for outsourced manufacturing and supply chain within your pharma business.

The aim of the session is to give delegates practical guidance on measures that they can implement to ensure robust and compliant agreements are in place for outsourcing of manufacturing and supply chain within the pharma business. There will be time at the end for an interactive Q&A.
 
The session will cover:

  • Approach and useful tips for negotiations
  • Basics of the agreement
  • Appointment, orders & delivery
  • Quality contractual requirements – warranty, remedies, disputes & UK Regulatory Inspectorate expectations
  • Indemnity – mitigation and insurance
  • Limitation of liability and breaches
  • Post-termination – what’s next
  • Q&A

Speakers:

  • Tom Cahill – VWV Senior Associate
  • Paul Gershlick – VWV Partner and Head of Pharmaceuticals & Life Sciences sector
  • Regina Dawkins – PharmaLex UK Associate Director/Senior Consultant, Quality Management and Compliance

Regina Dawkins is an experienced Director/Senior Manager with 30 years in the pharmaceutical industry, working across the UK and Ireland, with a wealth of experience and knowledge in the fields of API’s, Manufacturing (Commercial and Development across various product forms), Storage, Distribution and Transportation. She possesses excellent knowledge of outsourced and global supply chains. During her career, she has been a Global Quality leader and influencer, with people management responsibilities.Regina has also been listed as a Responsible Person on Wholesale Dealers Authorisation in both the UK and Ireland. With an excellent knowledge of EU and US GMP and Controlled Substance regulations, she has a proven track record of partnering with third parties incorporating relationship management and development of mutually acceptable compliance goals. She has strong capabilities in the performance of compliance evaluations and risk assessments on complex GMP and GDP related issues, along with a knowledge and experience of supporting product launches in Russian/CIS countries, Brazil, China, Korea, Europe, US and MENA countries.

Please note: As we are running this webinar jointly with PharmaLex, please be aware that we will be sharing your name, the name of the organisation you work for and your email address with them. Please see our privacy page to find out how we protect and use your data. If you do not want us to share your information with PharmaLex, please let us know by contacting events@vwvplus.co.uk.

We hope you are able to join us. If you have any queries, please contact the Events team.

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Details

Date:
May 26
Time:
3.00 pm - 4.00 pm
Event Category: