Hilary Gray
 Hilary graduated from the University of Nottingham with a BSc in Chemistry and then joined the Wellcome Foundation as an Analytical Chemist. She has had an extensive career in pharmaceutical analysis in the UK, also working for SmithKline Beecham, Pfizer and Reckitt Benckiser. She has been involved in the development process from pre-human to post-filing studies for novel drugs, both human and veterinary, and OTC products. In each position, Hilary found herself spending a lot of time writing both technical and regulatory documentation, and supporting regulatory activities. In 2011 she decided to make a sideways move to a position as a writer in the Regulatory Strategy team at Reckitt Benckiser Pharmaceuticals in Richmond, Virginia USA. The writing role was a gateway position to a career in Regulatory Affairs, and in 2014 Hilary returned to the UK to take up a position as a Regulatory Manager for Indivior UK Ltd (formerly Reckitt Benckiser Pharmaceuticals). She still spends a lot of time writing and editing regulatory documentation!
Joseph Irwin
Joseph Irwin is a Biochemist/ Pharmacologist by training with experience in Clinical Trials, pharmacology models, cell biology & molecular biology techniques. Joseph has over 25 years as a regulatory professional in all therapeutic areas in the EU. He has extensive experience in regulatory strategy and submissions for clinical trials, centralized, decentralized and mutual recognition procedures. Joseph has been lead writer for a number of Scientific Advice, Paediatric Investigation Plans, Orphan Designations, clinical trials applications, Community Referrals (Centralised, Decentralized and MRP), clinical and non-clinical overviews and summaries. He has prepared applications for Small Medium Enterprise status request to the EMA. He has been part of the team working on Investigator Brochures, Clinical Trials Protocols, Clinical Study Reports, DSURs, PSURs, PBRERS and NICE and reimbursement support documents. Joseph has extensive experience of SmPC and PIL labelling reviews, preparation of variations and updates to commercial packs.
Kathryn Brouder
 Kathryn is a professional manager, qualified as Associate to Chartered Management Institute standards, and an experienced eCTD publishing and submissions specialist. She spent over five years with NDA, working on many submission types for various clients. She was has worked on four Initial MAAs, which were carried through to approvals. She created their publishing SOP, produced a whitepaper and journal, worked on many internal projects; and aided clients on publishing guidelines and template creations. It was at NDA that she became the manager of the Reg Ops team, and gained the ACMI qualification.
In 2014, she moved to Takeda to gain experience in ROW submissions. Along with maintaining Master CTDs, she submitted to new countries moving to eCTD for the first time, including Saudi Arabia and Australia and submitted the first eCTD pilot to Brazil. Kathryn is currently the Reg Ops Manager at BioMarin UK, leading a team working on EU & US submissions, overseeing planning and developing processes and templates.
Patricia Vest
Patricia founded medical device software and sterilisation professionals in 2017 to develop interactive trainings using different type of supports. The trainings are done in-house, externally or by e-learning based on 20 years of experience in the medical device industry and 6 years of experience as a trainer in an engineer school. Our objective is to provide a training of quality for developing knowledge and competencies. The company can also provide some support to the medical device companies.
Pete Bennett
 Pete is a biochemist by training and a medical writer by profession. He has 20 years’ experience in the pharmaceutical industry. Before starting his career in medical writing at Gilead Sciences, he worked within the medical information departments at Gilead Sciences, Shire Pharmaceuticals, and Amgen. Pete has hands on experience preparing a variety of clinical documents, and has managed several submissions from a medical writing perspective.
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