Industry Faculty

Bo Yang

James Agnew

James Agnew is a supervising associate at Simmons & Simmons. He has worked on a range of contentious and non-contentious intellectual property matters including commercial licensing, collaboration...

Robert Alvarez

After completing his degree in molecular biology at the University of Reading, Robert Alvarez has been at Lonza Biologics for 17 years, of which 14 were spent working in the product stability...

Tina Amini

Dr. Tina Amini, a pharmacist with PhD in Pharmaceutics. She has over 30 years experience in Pharmaceutical and Medical Devices. She previously held the positions of Head of Notified Body and...

Stuart Angell

Stuart Angell is a joint director in his own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices focusing on the transition...

Leela Barham

BSc (Economics), MSc (Health Economics) Leela Barham is an independent health economist and policy expert working on a freelance basis. This follows 7 years at a specialist economic consulting...

Glyn Belcher

Dr Glyn Belcher has over 25 years experience in clinical development and drug safety in the pharmaceutical industry. He qualified in medicine from Oxford and Cambridge and received his PhD in...

Janette Benaddi

Janette Benaddi is an Independent Consultant and previously the Director of Clinical & Consulting Europe for NAMSA. NAMSA is a global Medical Research Organization offering a breadth of services...

Bi Jun

Xisca Borras

Maikel Bouman

Maikel Bouman works as a Senior Regulatory Operations Manager at Qdossier and in his role he has a strong focus on managing Regulatory Operations, coordination, and development of staff; planning and...

Laura Brown

Dr Laura Brown MBA, BSc (Biochemistry), BSc (Psychology), PhD, Diploma in Clinical Science, FICR, is a Pharmaceutical Management and Training Consultant, Course Director for the MSc in Clinical...

Will Burton

Will Burton, Director of Russell Square Quality Representatives (RSQR) Ltd, is engaged in providing a range of consultancy and training services to the international medical device, pharmaceutical...

Annette Callaghan

Tom Carver

Tom Carver is a partner at McCarthy Denning. He has broad experience in patent litigation (infringement and validity) in pharmaceuticals, medical and mechanical devices and electronics, including...

Montserrat Cerrato Sánchez

Alan Chalmers

Dr Alan Chalmers is a pharmacist with over 35 industrial experiences mainly in the field of pharmaceutical regulatory affairs. A graduate of Strathclyde University in Glasgow with a B.Sc. in...

Dale Charlton

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...

Philip Clay

Philip is Director and Principal Toxicologist with Chorley Consulting. He is a UK and European registered toxicologist and specialises in product safety assessment with over 30 years experience in...

Koen Cobbaert

Nancy Consterdine

Nancy Consterdine is a joint director in her own consultancy specialising in global regulatory affairs strategy and compliance for in vitro diagnostics and medical devices, focusing on the...

Bruce Davis

Bruce Davis runs his own training/consultancy company for science and risk based approaches to Engineering and Process Validation (PV), Quality by Design (QbD), Technology Transfer (TT), Quality...

Param Dayal

Drug Safety Manager at Pharma To Market

Mr. Param Dayal is a qualified Microbiologist with Master’s degree in Microbiology and a certified MedDRA coder. For the last 15 years, Param has worked on...

Alex Denoon

Alex Denoon is head of the regulatory team at Bristows, primarily advising life sciences clients. He has more than 20 years’ experience advising clients in the sector. In addition to his LLB,...

Monica Dressler-Meyer

Mónica Dressler-Meyer is DRA Manager based in Switzerland with many years of regulatory experience. She has spent many years in DRA working with different pharmaceutical companies with...

Mustafa Edik

Mustafa Edik is an Independent GMP Consultant and Auditor.  

After graduating as a Chemist from university, Mustafa began his 25 year plus career as a Laboratory Supervisor at Bayer, a German...

Niels Ersbøll

Niels Ersbøll, Partner, Arnold & Porter LLP, advises clients on EU competition law in relation to cartels and restrictive practices, merger control, abuse of dominance and State aid. He is...

Craig Evans

Marc Feary

Marc Feary is Principal Scientist at Lonza. He has greater than 15 years’ experience in biopharmaceutical development and bioproduction, having held R&D and commercially-focused roles at Lonza...

Richard Featherstone

Richard Featherstone is Research Director, Human Factors Research & Design, Emergo by UL, and previously Managing Director of Medical Device Usability Limited, a specialist human factors...

Joanne Flitcroft

Joanne is a qualified solicitor with over 22 years’ experience. She trained in the City of London and later specialised in pharmacovigilance as part of a FTSE 100 pharmaceutical company’s global...

Shelley Gandhi

Shelley is currently using her regulatory experience to work with the pharmaceutical industry to ensure they implement the new pharmacovigilance legislation. Shelley is part of the NDA Group AB...

Barbara Grossman

Barbara is a Biochemist and a Medical Writer, Editor and Teacher by profession, with 20+ years’ experience in the pharmaceutical industry. Barbara has started her own medical writing and...

Adrian Haines

Dr Adrian Haines is a Senior Process Manager within MSAT at Sobi (Swedish Orphan Biovitrum). Adrian has extensive experience in generating mammalian cell lines suitable for the GMP production of...

Susanne Hall

Susanne Hall began her career in 1990 at Dr. Karl Thomae in Biberach as Head of Packaging
Technology. In 1993, she joined Vetter’s Research and Development department as Head of
Packaging Material...

Anna Harrington-Morozova

Anna Harrington-Morozova is a regulatory, drug development and external relations professional with over 20 years’ experience gained working in a Regulatory Authority, academia and industry....

Heba Hashem

Heba has been working with Regulatory Affairs in the Middle East for more than 25 years. She has a Pharmaceutical and Business background being a graduate of the Faculty of Pharmacy (Cairo...

Eliana Henriquez Rodríguez

Robert Hersowitz

Robert Hersowitz has established an international reputation as a management and management development consultant. He has spent the past thirty years designing and delivering programmes and...

Andrew Hewitt

Dr Andrew Hewitt is a veterinarian with over 14 years of experience in Veterinary Medicinal Product development in a clinical and regulatory capacity. In his current position as Senior Advisor for...

Rhydian Howells

Rhydian Howells, associate director of regulatory affairs at Diamond Pharma services a Propharma group company. 20 years’ experience in the industry, 10 years at a large contract manufacturer...

Graham Howieson

Graham Howieson is a pharmaceutical business development consultant, inventor and entrepreneur. He is a highly experienced  and competent leader, with an International pedigree covering UK, EU,...

David Howlett

In 2003 David established PharmaDelivery Solutions Ltd as a specialised consultancy service in the field of drug delivery combination products (especially respiratory) device technology. This has...

Jonathan Hughes

Jonathan Hughes, Ph.D., FTOPRA, has over 35 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic – device combination products and in-vitro...

Salma Ismail

Salma Ismail is the CEO of Twinz Regulatory Affairs Pharmacist Consultants based in South Africa. Salma has over 25 years’ experience in the Pharmaceutical Industry and in Regulatory Affairs,...

Seema Jaitly

Dr Seema Jaitly qualified in Medicine from Charing Cross and Westminster Medical School in 1992 and worked in hospital medicine for four years. She has worked in the pharma industry for over 18...

Theresa Jeary

Theresa Jeary holds a Master’s Degree in Pharmaceutical Science and is eligible to be a Pharmaceutical Qualified Person. Theresa has over 25 years’ experience working in both the Pharmaceutical...

David Jefferys

Dr David Jefferys is Senior Vice President for Global Regulatory, Government Relations, Public Affairs and Patient Safety (EMEA, Russia and Australasia) at Eisai. After qualifying, he worked in...

Roger Joby

Roger Joby:  Director 1to1to1 Project Management Consultancy and Visiting Research Fellow Liverpool JM University

An international pharmaceutical project management consultant and educator with...

Adrian Keene

Adrian Keene is Director, Product Development Strategy at NAMSA, where he utilises his broad experience of changing EU medical device regulatory requirements to support clients worldwide. He was...

Ben Kokx

Ben Kokx joined Philips in 2001 as a software designer. He quickly moved into a new role as a product security and privacy officer and worked as such in several business and market positions....

Zuzanna Kwade

Zuzanna Kwade is Software Clinical Evaluation Lead at Dedalus Healthcare. Zuzanna holds a PhD in Biochemistry and has 15 years of experience in clinical and medical research. She is the co-author...

Graeme Ladds

Graeme Ladds, Director of PharSafer, has over 30 years’ experience working in the pharmaceutical industry. Having started his career at Ashbourne Pharmaceuticals in 1989 as Head of Drug Safety &...

Norah Lightowler

Norah Lightowler is a partner in Lightowler Associates, an independent consultancy offering regulatory advice and support to pharmaceutical companies in or proposing to enter the European market...

Peter A. Lowe

After a Ph.D and postdoctoral positions in the UK and USA in protein biochemistry Peter joined Celltech (now part of UCB Pharma). There he was involved in biologics discovery. His next relevant...

Priyanka Mangle

Pharmacovigilance Manager at Pharma To Market

Ms. Priyanka Mangle is a Pharmacist with Master’s degree in pharmacy and post-graduate diploma in clinical research. She is an experienced...

Mardon McFarlane

Mardon McFarlane is an Associate Director in the External Manufacturing group at CRISPR Therapeutics and is responsible for the relationship management and overall governance of an external global...

Colin McLean

Colin McLean has over 30 years of experience in in veterinary medicinal product development and registration. He previously managed the Animal Health Product Development team for a global CRO,...

Rona Middlemiss

Rona is a Senior Safety Assessor with Chorley Consulting. She holds a first class MSci in Biomedical Sciences from the University of Aberdeen and is a member of the Royal Society of Biology....

Mel Munro

Dr Mel Munro has worked as a consultant in veterinary medicinal product development and registration for over 20 years. She provides regulatory advice on all areas of biologicals product...

Lukas Munzinger

Makram Nehme

Makram Nehme is a Regional Regulatory Consultant having relevant experience with multiple multinationals including Parexel international, based in Lebanon. He has more than 10 years’ experience...

Raymond Ng

Senior Regulatory Affairs Manager at Accestra Consulting

• Mr. Ng is based in China with almost a decade of regulatory affairs experience of the Chinese market with a Master’s Degree from the...

Fred Nicolle

Peter O'Callaghan

Peter O’Callaghan holds BSc and PhD degrees in Genetics from Newcastle University. Since graduation he has gained over 10 years’experience in biotechnology research and development in academia...

Cormac O'Prey

Cormac O'Prey is Principal and Director in the Kestrel Consultancy Group.

He has experience in effective Business Development, Project Management and Product Development, with proven...

Declan O'Rourke

Declan O’Rourke has over 20 years’ experience in industry where he has held technical, marketing, product development, clinical development, production and pharmacovigilance roles.

He is a...

Adekunle Onadipe

Dr Adekunle Onadipe is an Associate Research Fellow in Bioprocess R&D, Cell Line Development at Pfizer Inc. USA. He leads a group of scientists responsible for the construction, development and...

Oguz Ozden

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...

Paul Palmer

Paul R Palmer is a Director / Pharmaceutical Consultant and a practicing EU / UK Qualified Person. He has over 35 years experience in the pharmaceutical industry in the development,...

John Parkinson

John Parkinson is a Data and Pharmaco-epidemiology Consultant. He previously worked as Director of the Clinical Practice Research Datalink (CPRD) at the MHRA, which developed out of the General...

Dave Parry

David Parry is a chemist with over 14 years of experience in in veterinary medicinal product development and registration. In his current position as CMC team leader at knoell, David works with...

Chris Penfold

Chris Penfold is an experienced Freelance Packaging Development Specialist and Consultant; a self-motivated, achievement oriented, confident and creative leader with a proven track record in...

David Petrick

Dr David Petrick has over 30 years’ experience in bringing novel animal health products to the marketplace. During his professional career he has worked in Regulatory Affairs and Product...

John Price

Dr John Price is a physician consultant in pharmacovigilance and regulatory affairs, working with several small biotechnology companies in North East USA planning submissions for marketing...

Ilona Putz

Ilona Putz is the founder and General Manager of PULONA Emerging Markets based in the UAE since 2008. Her company is dedicated to creating and developing tailor-made business concepts including...

Stephen Reese

Stephen Reese is a partner at Clifford Chance and advises clients on both contentious and non-contentious intellectual property matters including patents, trade marks, trade secrets and copyright....

Irene Rossi

Irene Rossi is the Head of New Modalities Pharmaceutical Development at Nanopharm, an Aptar Company (UK). Irene obtained a MSc in Pharmaceutical Chemistry and Technology in 2014 and a PhD in...

Andreas Rothmund

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...

Dave Rushton

Dave Rushton is the Founder of Paradigm Shift Consulting, an ISO 9001: 2015 accredited company for training and quality management services to the pharmaceutical industry. 

Paradigm Shift...

Saad Shakir

Saad Shakir is a pharmacoepidemiologist and drug safety physician. He has worked in the fields of pharmacovigilance, pharmacoepidemiology and risk management for 30 years, initially at the UK...

Paul Shields

Dr. Shields holds a Ph.D. in Biochemistry from the University of Pennsylvania and a B.S. in Chemical Engineering from the University of Michigan. He has 33 years of experience in process...

Jag Shur

Dr Shur is an academic and entrepreneur having over 100 published scientific papers and was CEO of Nanopharm Ltd, which he led to a successful exit in 2019. Jag’s main area of research and...

Kristi Smedley

Kristi O. Smedley, PhD, has been consulting in the regulation of Food and Drug Administration (FDA) regulated products since 1996. Previous to this she worked at the FDA’s Center for...

Sanjeev Srivastav

Dr Sanjeev Srivastav, Director of PV Signal, is a highly analytical and quality-focused healthcare professional with over 20 years experience in Clinical Medicine, Pharmaceuticals and Health...

Daniel Sturm

Mario Subramaniam

Mario Subramaniam is a Legal Director in the Life Sciences Transactions team at Pinsent Masons. As a former research scientist, he has a passion for the life sciences and has expertise in advising...

Julie Suman

Dr. Julie D. Suman is the Vice President of Scientific Affairs for Aptar Pharma. She manages strategic scientific planning and Aptar’s Scientific Advisory Board. Dr. Suman is also the co-founder...

Donna Taylor

Donna is a University of Birmingham graduate with an honours degree in Biochemistry that included an industrial placement year at Celltech R&D, Slough (now UCB). Post-degree, Donna returned to...

Ben Thomas

Ben Thomas is a Managing Associate at Simmons & Simmons. He has experience of working across a range of contentious and non-contentious intellectual property matters, with a focus on patent and...

Raphael Tian

Pharmacovigilance Manager at Accestra Consulting

Mr. Raphael Tian is a seasoned pharmacovigilance Manager at Accestra Consulting, with extensive experience in top global pharmaceutical companies...

Hans van Bruggen

Hans van Bruggen is CEO of and Senior Regulatory Affairs Scientist at Qdossier. He holds an MSc. in Pharmaceutical Medicine from the University of Surrey (UK) and has worked in the pharmaceutical...

Marloes van der Geer

Marloes van der Geer works as senior regulatory affairs scientist at Qdossier. Marloes holds a master in Life Sciences (Drug Innovation) from the University of Utrecht, the Netherlands. For nine...

Philip Webber

Dr. Philip Webber obtained his first degree from Cambridge University, UK (Natural Sciences, Genetics) and then carried out research on the regulation of brain-specific genes at Warwick...

Jenny Webster

Jenny Webster began her role as Monitor of Veterinary Clinical Studies in 2013. Prior to that she was a Registered Veterinary Nurse (RVN) working in clinical practice in the UK. Jenny has...

Andrew Willis

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...

Nick Wills

Nick Wills is a regulatory affairs advisor with over 10 years of experience in Veterinary Biologics development in a regulatory and quality assurance capacity. In his current position as an...

Paula Wittels

Key positions held in career
Programme Director Translucency Ltd
Director of Operations Quintiles Consulting, specialising in medical device reimbursement
Marketing Director Howmedica...

Helen Ye

RA & PV Director at Accestra Consulting 

• Ms. Ye has been dedicated to regulatory affairs consulting for 15 years with a Pharmacy degree from Zhejiang University, China. 
• She is experienced in...

Marylene Zhan

Senior consultant at Accestra Consulting

Ms. Marylene Zhan is a senior consultant at Accestra Consulting with extensive experience in pharmacovigilance and regulatory affairs, with a Master's...