Current position and relevant professional experience:
I have almost 30 years of regulatory affairs experience in medicinal product and medical device development, including extensive experience of ICH and CHMP guidelines and ISO standards for medical devices and in vitro diagnostics. I have written several chapters for books on drug development and Regulatory Affairs and write for several peer-reviewed journals including the Regulatory Rapporteur.
I speak on a variety of MSc courses (including the TOPRA MSc) and at global conferences on a regular basis. I was honored with a TOPRA Award for Regulatory Excellence in 2015.
My career has seen me work in a variety of settings from large pharma to startup companies and from small CROs to multinational outfits. I am currently having a short career break but will be taking up a role as Vice President, Regulatory Consulting at a mid-size CRO in September 2020.
Current or previous involvement in TOPRA activities:
I have had a long association with TOPRA and its predecessor BIRA. From working with the BIRA East team in the early part of my career (25+ years ago), to speaking at the TOPRA symposium as my career progressed. I have been a member of the Regulatory Rapporteur editorial team and its predecessor BIRA News for a number of years and have regularly edited, written and reviewed for our flagship publication.
I have previously held a position on the Board at TOPRA for nine years, three of those as part of the presidential Troika, becoming President in 2018. I am also a member of the diversity panel and the medical devices working party.
My year as President saw the successful launch of the CSci accreditation for our members and precipitated changes which have been continued by those following me.
In addition, I speak on the TOPRA MSc being Co-Chair in two modules and a speaker in two others.
Personal statement:
I feel my background, experience and enthusiasm for the TOPRA organization makes me a capable ambassador for the membership. This organization belongs to the members and I understand the importance of listening to the needs of TOPRA members and I believe that I can continue to voice these needs and provide relevant strategic input to the Board to help shape the future of TOPRA, continue with the changes I have previously helped to implement and which have been further implemented by the current board and provide stability in these uncertain times. I would appreciate your support to make it happen.
Nomination information
Proposer: Dianne Lee; Seconders: Sarah Roberts, Eva Kopecna