The Role of CMC RA Professionals in Business Continuity Planning

Register for our webinar on The Role of CMC RA Professionals in Business Continuity Planning
With its major economic impact, the current pandemic has brought business continuity planning to the fore. In this webinar, we shall discuss how CMC regulatory affairs specialists can make valuable contributions to the resilience planning process, from the analysis stage to the action plan and implementation.
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Michelle joined the company in June 2015 and has worked in regulatory affairs since 1996. Her background is in human pharmaceuticals, with 18 years’ experience in the pharmaceutical industry, moving to consultancy in 2014.
Michelle’s current role in the company is Managing Consultant in charge of the Malta office.
Michelle is part of the management team of the company. Her main expertise is in chemistry, manufacturing, and controls (CMC), marketing authorisation procedures, regulatory intelligence, and project management. Responsibilities include management of the Malta team while providing expert input to clients.

Claire Corinne joined the company in October 2017 having worked in regulatory affairs since 2000. Claire’s previous experience in the pharmaceutical industry includes Chemistry, Manufacturing and Control (CMC), EU regulatory affairs, supporting pharmaceutical development from a regulatory perspective, Module 3 audit, risk assessment, gap analysis and upgrading, dossier compilation (Modules 1, 3 and QOS), responding to CMC deficiency letters, life cycle management and also project and team management.
Claire’s current role in the company is as a Senior Regulatory Affairs Consultant.