Online training during Covid restrictions - our programes continue this spring in online webinar format

Life Sciences Faculty

The following expert presenters are scheduled to present our courses:

Tina Amini

Dr. Tina Amini, a pharmacist with PhD in Pharmaceutics, is Director of Medical Device Division at NDA Group. She has over 30 years experience in Pharmaceutical and Medical Devices. She previously...

Speaking on Drug/Device and Device/Drug Combinations in the EU and USA
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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...

Speaking on Introduction to the In-Vitro Diagnostic Regulation (IVDR)
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Elizabeth Baker

Elizabeth is Group Manager, Licensing Group 1 and Drug/Device Enquiries, MHRA. The unit has responsibility for advising on the drug/device borderline, advising on regulatory aspects of drug/device...

Speaking on Drug/Device and Device/Drug Combinations in the EU and USA
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Speaking on The Medical Device Summer School - From Concept to CE Marking
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George Barrie

George Barrie is a Consultant to the Pharmaceutical Packaging Industry.
Until recently he was with Actavis where his role was to bring all elements of packaging design, regulatory requirements and...

Speaking on Pharmaceutical Packaging, Labelling and Artwork Origination
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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...

Speaking on Pharmacovigilance
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Janette Benaddi

Janette Benaddi is a business mentor, international speaker/trainer and consultant to the medical device industry. Janette has over 25 years’ experience of managing pre and post market clinical...

Speaking on Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
and 7 more Full details...

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...

Speaking on Filing eCTD Submissions
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Julian Braidwood

Julian Braidwood qualified as a Veterinary Surgeon and worked in mixed practices before spending fifteen years in R&D and Regulatory departments of five leading Animal Health companies. Julian...

Speaking on Practical Implementation of GCP in Veterinary Field Studies
and 3 more Full details...

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...

Speaking on Clinical Quality Management Systems
and 9 more Full details...

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...

Speaking on An Introduction to the Medical Device Regulation
and 2 more Full details...

Speaking on Registration of Animal Feed Additives in the EU
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Speaking on Pharmaceutical Regulatory Affairs in China
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Speaking on The Medical Device Summer School - From Concept to CE Marking
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Philip Clay

Philip Clay 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’...

Speaking on Biological Evaluation of Medical Devices
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Koen Cobbaert

Koen Cobbaert is Quality and Regulatory Manager at Philips Healthcare. He represents COCIR in numerous work groups at European level. Koen has over 15 years of hands-on experience in establishing...

Speaking on Medical Device Software: Complying with the EU MDR & FDA Regulations
Full details...

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...

Speaking on Introduction to the In-Vitro Diagnostic Regulation (IVDR)
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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), Quality Risk Management, GMP for...

Speaking on Effective Technology Transfer
and 1 more Full details...

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,...

Speaking on Drafting and Negotiating Clinical Trial Agreements
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Speaking on Drafting and Negotiating Clinical Trial Agreements
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Ian Douglas

Professor Ian Douglas is an epidemiologist, currently funded by an MRC Methodology Fellowship. He initially studied physiology and completed a PhD in Manchester. Since then he has spent several...

Speaking on Pharmacovigilance
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Barry Drees

Dr Barry Drees has a PhD in molecular biology and he is an experienced trainer of medical writers today. He graduated from the University of California Santa Barbara and the University of...

Speaking on Successful Medical Writing
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Speaking on Pharmaceutical Regulatory Affairs in China
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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...

Speaking on Human Factors and Usability Engineering in the Development of Drug Delivery Products
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Speaking on Pharmaceutical Packaging, Labelling and Artwork Origination
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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...

Speaking on Pharmacovigilance Aspects of Licensing Agreements
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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...

Speaking on Pharmacovigilance
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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...

Speaking on Effective Technical Writing & Editing
and 2 more Full details...

Adrian Haines

Dr Adrian Haines is the Head of Science and Technology at Sobi AG, based in Geneva, Switzerland. Adrian has extensive experience in generating mammalian cell lines suitable for the GMP production...

Speaking on Biotechnology for the Non-Biotechnologist
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Speaking on Pharmaceutical Packaging, Labelling and Artwork Origination
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Speaking on Medical Device Regulation in the Eurasian Union, Russia and the CIS
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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...

Speaking on Pharmaceutical Regulatory Affairs in the Middle East
and 1 more Full details...

Mike Holroyd

Mike Holroyd is Senior Director with responsibility for the design, development and scale-up of inhalation devices within the Mylan Global Respiratory Group. He has an MA in Engineering from St....

Speaking on Dry Powder Inhalers
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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...

Speaking on An Introduction to the Design and Development of Medical Devices
and 2 more Full details...

Jonathan Hughes

Jonathan Hughes, Ph.D., FTOPRA, has over 32 years of worldwide regulatory and clinical affairs experience across medical devices, drug / biologic – device combination products and in-vitro...

Speaking on Drug/Device and Device/Drug Combinations in the EU and USA
and 1 more Full details...

Janine Ingleby

Janine Ingleby is a Senior Safety Assessor with Chorley Consulting. She holds a MSc in Global aquatic biodiversity and a BSc in Molecular biology and biotechnology, both from the University of...

Speaking on Biological Evaluation of Medical Devices
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Speaking on Pharmaceutical Regulatory Affairs in Africa
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Speaking on Pharmaceutical Packaging, Labelling and Artwork Origination
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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...

Speaking on Pharmacovigilance
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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...

Speaking on An Essential Overview of the Medical Device Industry
and 3 more Full details...

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...

Speaking on An Essential Overview of the Medical Device Industry
and 2 more Full details...

Speaking on The Medical Device Summer School - From Concept to CE Marking
Full details...

Speaking on Medical Device Software: Complying with the EU MDR & FDA Regulations
Full details...

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 &...

Speaking on A Practical Guide to Producing and Maintaining the PSMF
and 6 more Full details...

Sue Lester

Sue Lester qualified with a degree in Biology and Chemistry and worked in the UK government’s veterinary diagnostic laboratories before spending the last 30 years in the Animal Health industry. ...

Speaking on Practical Implementation of GCP in Veterinary Field Studies
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Speaking on EU Pharmaceutical Regulations & Strategy
and 1 more Full details...

Speaking on Pharmaceutical Packaging, Labelling and Artwork Origination
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Carol Markwell

Carol Markwell is a Consultant with more than 30 years experience in pharmacovigilance. She was one of the first to gain the Postgraduate Diploma in Pharmacovigilance from the University of...

Speaking on Pharmacovigilance
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Elinor McCartney

Elinor established Pen & Tec Consulting in 2000, coinciding with publication of the EU white paper on food safety, and dedicated to providing specialist services in new product development and...

Speaking on A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
and 1 more Full details...

Speaking on Pharmaceutical Packaging, Labelling and Artwork Origination
Full details...

Helen Muirhead

Helen Muirhead is now an independent Respiratory Medicine Expert, acting as a consultant after 30 years with GSK in both R&D and Manufacturing. Helen is also involved in teaching at Universities...

Speaking on Dry Powder Inhalers
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Ray Munden

Dr Raymond Munden has over 40 years’ experience in pharmaceutical research and development and was formerly Head, Analytical Services Europe for GlaxoSmithKline. He has led project teams that...

Speaking on Stability Testing of Pharmaceuticals and Biopharmaceuticals
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Speaking on Pharmaceutical Regulatory Affairs in Africa
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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...

Speaking on Biotechnology for the Non-Biotechnologist
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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...

Speaking on Periodic Safety Update Reports for Veterinary Medicinal Products
and 2 more Full details...

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...

Speaking on Biotechnology for the Non-Biotechnologist
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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...

Speaking on Pharmacovigilance
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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...

Speaking on An Introduction to Pharmaceutical Packaging
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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...

Speaking on Working Through Veterinary Drug Development in the EU and USA
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Ilona Putz

Ilona Putz founded PULONA Emerging Markets based in the UAE which is dedicated to creating and developing tailor-made business concepts for clients in the healthcare sector across the Middle East....

Speaking on Pharmaceutical Regulatory Affairs in the Middle East
and 1 more Full details...

Mark Richardson

Mark Richardson is a Pharmaceutical/Biotech Drug Development Regulatory Affairs Consultant and is also Director of Richardson Associates Regulatory Affairs Ltd. After postdoctoral research in...

Speaking on Biotechnology for the Non-Biotechnologist
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William Richardson

Bill Richardson is a Medical Assessor at NDA Group. He initially qualified in medicine and trained as an anaesthetist, before moving to the Pharmaceutical Industry, working for 15 years in Medical...

Speaking on Pharmacovigilance
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Speaking on The Medical Device Summer School - From Concept to CE Marking
Full details...

Saad Shakir

Saad Shakir is Director of the Drug Safety Research Unit. After qualifying and working in Medicine he has been working in pharmacovigilance & pharmacoepidemiology for more than a decade, initially...

Speaking on Pharmacovigilance
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Paul Sim

Paul Sim, Regulatory Affairs Manager, BSi Group. Paul has worked in the healthcare industry for 34 years and is currently Project Managing BSI’s implementation of EU Commission Recommendation...

Speaking on Technical Documentation to Comply with the MDR and IVDR
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Kate Smith

Kate Smith is currently Principal Scientist, Development Services, at BioReliance, UK, part of the Merck Group. In this position she is reponsible for providing technical supprt to both colleagues...

Speaking on Biotechnology for the Non-Biotechnologist
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Speaking on Medical Device Studies: Clinical Evidence
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Alison Sykes

Alison Sykes is Director Physico-Chem Analytics, for Fresenius-Kabi, SwissBio Sim, a post she took up in 2017. She was formerly a Director within the Biosimilar Unit of Merch Serono and Biosimilar...

Speaking on Biotechnology for the Non-Biotechnologist
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Greg Thay

Greg Thay is the founder and principle human factors consultant at THAY Medical, and has over twenty years’ experience in the medical and pharmaceutical industries. He has worked in many therapy...

Speaking on The Medical Device Summer School - From Concept to CE Marking
Full details...

Marie-Pascale Tiberghien

Marie-Pascale qualified from Lyon Veterinary School, France. She holds an MSc in Applied Statistics from Sheffield Hallam University, 1997. She has worked in the veterinary pharmaceutical industry...

Speaking on Practical Implementation of GCP in Veterinary Field Studies
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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...

Speaking on Filing eCTD Submissions
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Speaking on Borderlines between Medicines and Food
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James Visanji

Dr James Visanji PhD MCIL works at Trilogy Writing & Consulting GmbH. James is a trained medical scientist and linguist. He has postdoctoral research experience in oncology and cell biology at...

Speaking on Successful Medical Writing
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Speaking on Pharmaceutical Packaging, Labelling and Artwork Origination
Full details...

Speaking on Stability Testing of Pharmaceuticals and Biopharmaceuticals
Full details...

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...

Speaking on Biotechnology for the Non-Biotechnologist
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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...

Speaking on Common Technical Document
and 7 more Full details...

Alison Wilson

Alison is an Independent Regulatory Affairs Consultant. Previously Regulatory Affairs Manager for Smith & Nephew Wound Management, she has over 25 years’ experience of regulatory affairs in...

Speaking on Drug/Device and Device/Drug Combinations in the EU and USA
Full details...