Norah Lightowler

Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market for human pharmaceuticals. They are in their twenty fourth year of successful business. She has wide experience in the pharmaceutical and related nutraceutical, herbal and devices industries as a pharmaceutical assessor with the UK regulatory authority and as associate director of European regulatory affairs with an international pharmaceutical company. She is experienced in organising and presenting courses on European regulatory control systems, including requirements, procedures and strategy.

  • Next: 24 Jan 2024 Live online
  • Also: 22 May 2024 Live online
  • Also: 18 Sep 2024 Live online

EU Proposed Pharmaceutical Legislation Changes

New for 2024

Live online

On 26 April 2023, the European Commission proposed a new directive and regulation to revise and replace current pharmaceutical legislation. This course will provide an up-to-date overview of current European pharmaceutical legislation and the proposed changes. The potential regulatory impact of the proposed changes on company planning and strategy will be considered and discussed.

  • 3 CPD hours Focused
  • Presented by Norah Lightowler
  • Next: 12-13 Feb 2024 Live online
  • Also: 11-12 Jun 2024 Classroom
  • Also: 14-15 Oct 2024 Live online

EU Pharmaceutical Regulations & Strategy

Live online, Classroom

The course will provide an up-to-date overview of the current European pharmaceutical regulatory environment including procedures for obtaining marketing authorisation and post-approval obligations. The proposed changes to the EU pharmaceuticals legislation and post-Brexit changes in the UK will be discussed in the context of regulatory obligations and strategic considerations for obtaining and maintaining marketing authorisations.

  • 12 CPD hours Focused
  • Presented by Norah Lightowler
  • Next: 29-30 Jan 2024 Live online
  • Also: 13-14 May 2024 Classroom
  • Also: 24-25 Sep 2024 Live online

Regulatory Affairs for Support Staff

Live online, Classroom

This two-day course provides an introduction to pharmaceutical regulatory affairs and the basics of drug development and has been designed specifically for those working in a support staff role.

  • 12 CPD hours Focused
  • Presented by Norah Lightowler