Andrew Willis

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

  • Next: 26-27 Jan 2023 Live online
  • Also: 12-13 Jul 2023 Classroom
  • Also: 30-31 Oct 2023 Live online

Biosimilars

Live online, Classroom
Focused

A two-day seminar providing an essential overview of biosmilars and how they differ from the original biological product.

  • 12 CPD hours
  • Presented by Hans van Bruggen
  • and Marloes van der Geer
  • Next: 6-9 Feb 2023 Live online
  • Also: 20-21 Jun 2023 Classroom
  • Also: 16-17 Oct 2023 Live online

Pharmaceutical Development of ATMPs

Live online, Classroom
Focused

This course will provide a comprehensive overview of the regulatory, quality and GMP requirements to consider when developing ATMPs.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 20-21 Feb 2023 Live online
  • Also: 27-28 Jun 2023 Classroom
  • Also: 9-12 Oct 2023 Live online

Development of Combination Products: Critical Interactions

Live online, Classroom
Focused

Linking the technical requirements of device design and pharmaceutical product development. Using QbD to deliver drug/device combinations.

  • 12 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 28 Feb 2023 Live online
  • Also: 8 Jun 2023 Classroom
  • Also: 20 Oct 2023 Live online

US FDA - Understanding Key Factors When Working with the FDA

New for 2023

Live online, Classroom
Focused

This course has been designed to provide an essential overview of the key factors when working with the FDA.  It will equip senior managers and project managers with pivotal information to enable them to interact with their teams and ask critical questions to ensure the best outcomes when making applications to the FDA.

  • 6 CPD hours
  • Presented by Mr Andrew Willis
  • Next: 2-3 Mar 2023 Live online
  • Also: 6-7 Jul 2023 Classroom
  • Also: 26-27 Oct 2023 Live online

Chemistry, Manufacture and Control (CMC) - Regulatory Requirements for Biological Drug Products

New for 2023

Live online, Classroom
Focused

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

  • 12 CPD hours
  • Presented by Mr Andrew Willis