Theresa Jeary

Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. Theresa has over 25 years’ experience working in both the Pharmaceutical and Medical Device industries and has worked in a variety of roles across the full development cycle from product concept and early stage development, process transfer, validation and regulatory departments, and has been involved in the development of many commercially available medicinal and medical device products.

She has over 10 years Notified Body experience working at BSi as a technical expert and until January held the position of Head of Notified Body at LRQA. Her area of technical expertise is in device-drug combinations and borderline classifications, and she has completed many successful consultations in this area with many European Competent Authorities and EMA.

Theresa now works as a consultant to the Pharmaceutical and Medical device sectors and is a frequently invited speaker on medical device legislation and combination products.

  • Next: 30 Apr 2024 Live online
  • Also: 22 Oct 2024 Live online

A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK

Updated for 2024

Live online

This course will provide an excellent opportunity to hear the latest developments from regulatory experts, and enable participants to discuss the implications of the regulations on working practices and the potential impact on future regulatory strategies.

  • 6 CPD hours Focused
  • Presented by Theresa Jeary
  • Next: 15-17 May 2024 Live online
  • Also: 31 Jul-2 Aug 2024 Classroom
  • Also: 4-6 Nov 2024 Live online

An Introduction to the Medical Device Regulation

Live online, Classroom

This seminar provides a detailed introduction to the European medical device legislation. It will explain the Regulation and which products are covered, the involvement of Notified Bodies, how to choose one and outline what a manufacturer must do.

  • 18 CPD hours Focused
  • Presented by Theresa Jeary
  • Next: 4-7 Jun 2024 Live online
  • Also: 7-8 Oct 2024 Live online

Advanced Regulatory Affairs for Medical Devices

Live online

Planning your regulatory strategy to comply with the Medical Device Regulation (MDR)

  • 12 CPD hours Focused
  • Presented by Theresa Jeary
  • Next: 10-14 Jun 2024 Classroom
  • Also: 2-6 Dec 2024 Live online

The Medical Device School - From Concept to CE Marking

Summer school

Live online, Classroom

This comprehensive course has been designed to map the processes from device concept to marketing and show how regulatory, quality, clinical and other aspects of device development are joined into a continuous process.

  • 30 CPD hours Intensive
  • Presented by Theresa Jeary
  • Next: 8-9 Jul 2024 Live online
  • Also: 8 Nov 2024 Live online

An Essential Overview of the Medical Device Industry

Live online

This one-day workshop aims to give all the key information necessary to understand the regulation of medical devices and diagnostics and to appreciate the key differences from pharmaceutical regulation.

  • 6 CPD hours Focused
  • Presented by Theresa Jeary