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Dr Laura Brown is an independent pharmaceutical project management and training consultant. Laura has more than 25 years’ experience of managing clinical research projects in the pharmaceutical industry and has worked for several companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International. Laura has worked as a Life Cycle Project Manager, Clinical Research Project Manager and Head of a Training organisation in the Pharmaceutical industry. Laura has completed an MBA, with specialisation in project management. She is also the external project management expert for a pharmaceutical e-learning MSc module in project management and the author of two books on the subject including Project Management for the Pharmaceutical Industry.

Andrew Willis is an independent consultant providing expert advice and training on global regulatory solutions and pharmaceutical development. Previously, he worked for Catalent Pharma Solutions as VP Regulatory Affairs & Consulting Services, where he was head of a team of internal and external regulatory affairs consultants.

He qualified as a Chemist from the University of Glamorgan, after which he furthered his understanding of pharmaceutical development, working as a research chemist with Parke Davis. He had 10 years manufacturing and analytical experience prior to entering regulatory affairs as a Senior Executive Officer with responsibility for submission of European MAAs and project management of development programs. He has over 30 years’ pharmaceutical experience with extensive knowledge in the development and manufacture of sterile, solid oral, inhalation, topical and biotech pharmaceutical products. These experiences have allowed knowledge of many biotech products requirements with experiences of growth hormones and multiple cancer treatments, including development and clinical registration of the first genetically modified live bacterium for such treatment.
He has extensive experience of major European and US regulatory projects, in the clinical and marketing authorisation stages, and has significant experience in coordinating and managing meetings with European and US Health Authorities.

Six Sigma Black Belt certified by IASSC

Over 20 years of Regulatory, Quality, Clinical Trial and Pharmacovigilance experience in Asia with good knowledge in the field of Medical Devices, Pharmaceuticals, Nutritional, Consumer Healthcare and Biological products. Received awards on improving process (reduced 20% time in product launch time) and developing People (Watson Wyatt Survey to all direct reporting staff indicated that 100% of them able to contribute to their fullest ability).

Externally, playing a leading role among all the Regional Regulatory professionals in AHWP (Asian Harmonization Working Party). Developed the First Asia Regulatory Affairs Certificate course since 2007 with over 2800 students in industry, government and universities. Being the founder of ARPA (Asia Regulatory Professional Associations) since 2010 with over 3600 members. Wrote the first Asia Regulatory Book in Asia, Handbook of Medical Device Regulatory Affairs in Asia, 2nd edition now.

Qualified Auditor of ISO 13485, Japanese Regulations for Medical Devices and ISO 9000 Lead Auditor by BSI (British Standards Institution)

Sara Leiman, PhD, is an associate in Finnegan LLP’s Boston office. Sara works with domestic and international clients across the life sciences on global patent prosecution, strategic counselling, due diligence, and validity and infringement opinions. She writes and speaks regularly on topics in intellectual property--particularly patent eligibility requirements, case law, and patent office guidance in the US--and co-authored and co-edited the book Patent Subject Matter Eligibility: A Global Guide. 

Andy Spurr is a patent attorney at Canon Europe, specialising in software related inventions with a particular focus on video encoding and standard essential patents. Before joining Canon, Andy spent 8 years at a private practice IP firm where he worked with numerous software start-ups, advising on how to best leverage their IP to create commercial value.

Tim Whitfield is a partner with Powell Gilbert LLP. He advises clients in contentious IP matters across all IP rights with a strong focus on patent litigation and strategy, across a wide range of technologies, especially disputes having an international element in the pharmaceutical sector. He represents clients in cases before the English Courts and the European Patent Office. He has very extensive experience of advising clients on the co-ordination of international patent litigation strategy including in the pharmaceutical, medical devices and electronics fields. Tim also advises on related issues arising from international technology standards, patent pools and licensing, as well as pharmaceutical regulatory issues and SPCs. Tim also has experience of patent portfolio due diligence projects, contentious design right issues and trade mark infringement disputes.

Craig Evans is a chemist with over 13 years experience in the veterinary medicines field, working on everything from initial registrations to post-approval activities including change controls captured with variations. Craig works directly with multiple pharmaceutical companies, providing expert knowledge relating to a variety of areas of veterinary medicines. Craig has in depth knowledge of CMC activities, and has an excellent working understanding of Regulatory Guidelines in the EU.

Oguz is a strategy consultant in PwC’s Strategy& practice, leading large, complex and international transformations across the Pharma and Life Sciences sector. He has over 10 years of consulting experience in the sector having worked across various functions in Biotech, Pharma and Consumer Health as well as Pharmaceutical Wholesale.

Dr. Andreas Rothmund is Qualified Person (retd) at Vetter Pharma-Fertigung in Ravensburg, Germany, an independent contract manufacturer specialised in the aseptic production of pre-filled application systems. He started his industrial career in 1985 as a lab manager. After two years he took over production responsibility for a German company specialised in eye drops and eye ointments, a position he held for nearly eight years.

He joined Vetter in 1994, where he has held several positions, including Head of Production for one of Vetter’s aseptic production units. He holds a degree in organic chemistry from the University of Constance, Germany.

Dale Charlton is a Freelance Consultant for automation and fill / finish. Dale has spent a lifelong career in Life Sciences and Biotechnology encompassing both the academic and industrial sectors. Dale worked in a technical capacity in basic R&D at a major University and EMBL Heidelberg before embarking on a more formal academic career in biotechnology and studying for a PhD within the Drug Discovery Group of Pfizer into growth factor research (rGH, GHRF, IgF) . With industrial spells at Porton Down and Pittman-Moore (formerly Glaxo Animal Vaccines) in API and API scale-up, Dale settled back into biotech manufacture and moved more into the supply chain of finished drug products for small molecules & biologics, first as the MD of a life sciences distribution company and later as Director of Business Development, Optima pharma in sterile production automation. Having worked in the pharmaceutical industry from R&D to finished drug product, Dale has a unique understanding of the entire drug development life cycle and offers insight from both the pharma and a suppliers perspective.