Trainer Profile
Debra Lake is a highly competent Clinical Research Associate with experience in all aspects of monitoring from site start-up to close-out. Her working culture is heavily influenced by the focus on the customer ethic and the need for effective communication between teams to ensure shared success. Debra's therapeutic knowledge has been enhanced through her strong scientific background.
As well as training, Debra carries out monitoring clinical research projects for the pharmaceutical industry.
Key Clinical Experience
Site monitor for more than six years covering a variety of therapeutic areas, sites and study phases. Highly adept at site motivation, excellent attention to detail, source document verification, drug accountability, data query generation and resolution, site initiation through to close out and archive.
Experience of site and central file audit, for-cause audit and preparation for MHRA inspection.
Excellent communication and training skills used in training the sites on the Protocol and in training junior CRAs for the role.
Trainer Profile
Andrew Willis is a regulatory expert with 32 years of experience in pharmaceutical development. Experience at multiple levels within pharmaceutical companies and most recently as Vice President for Regulatory Affairs, gaining significant experience in co-ordinating, planning and running global development projects.
His experience is wide ranging, and will facilitate your understanding of fast, effective development of medicinal products, through early stages, through registration and continued Life Cycle Management.
Andrew has a wealth of experience which he will share from his multiple roles he has been involved with in the pharmaceutical industry, including:
- Interim Strategic advice to major pharmaceutical company for roll-out and compliance strategies for Russia / CIS, MENA, ASEAN, LATAM, South Africa and Switzerland, including ensuring appropriate staff development and strategies which ensure protection of intellectual property whilst maintaining patient focus.
- Orphan drug registrations of vaccine products and synthetic molecules
- NCE approved in US and Europe for urology product (Simultaneous NDA and EU Centralised Submission)
- Support for NBE during clinical phases and CMC support for a Biosimilar
Trainer Profile
Arthur is an internist-nephrologist by training. He joined the Medicines Evaluation Board (MEB) in the Netherlands in 1991 as senior medical assessor. In 1993 he started setting up the pharmacovigilance department at the MEB and headed that department from 1995 to 2001. During that period Arthur was also the national coordinator for pharmacovigilance, the Pharmacovigilance Working Party member for the Netherlands, and the European member within the ICH E2B group.
In 2001 Arthur joined J&J as senior medical advisor and Qualified Person for Pharmacovigilance (QPPV). Since 2010 he has acted as a PV consultant.
With his very broad PV experience, strategic views and strong team building skills he can be an asset to any organisation both hands on and strategically and draws on this experience to deliver entertaining and enlightening training programmes.
Trainer Profile
Virginia Watson has substantial and wide ranging experience as a medical/ clinical writer incorporating international/global management. She is an accredited trainer - giving public and in-house training on a wide of range of topics including introductory courses for medical writing, specific document training for clinical trials and regulatory affairs.
In addition she acts a Locum pharmacist in community pharmacy. Virginia has had 20 years’ experience in pharmacy practice before re-entering the industry. Here previous industry posts in medical information, marketing, product management for pharmaceuticals and immunodiagnostics.
Virginia specializes in writing all clinical documents related to clinical trials, regulatory submissions for MAA/NDA authorisation (pre and post submission), scientific advice meetings, PIL user testing etc.
peer review of above documents. She also writes general articles for different audiences and provides training and mentoring, conference programme planning. Virginia has significant committee experience (including chairperson) experience for membership organisations (EMWA, DIA, NAWP, IoD)
Further to the above Virginia was the President of The National Association of Women Pharmacists (NAWP) 2010-2013
Debra Lake
M.S.c
