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Life Sciences Faculty

The following expert presenters are scheduled to present our courses:

Speaking on Biotechnology for the Non-Biotechnologist
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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 The Medical Device School - From Concept to CE Marking
and 1 more Full details...

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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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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Karolina Bate

Karolina has worked in regulatory affairs for over 15 years. Karolina started her career working for Cyton Biosciences, becoming a Managing Director 8 years ago. Since the acquisition of kAH Ltd...

Speaking on The New EU Animal Health Legislation for Veterinary Medicinal Products
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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 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...

Speaking on Clinical Evaluation of Medical Devices: The Clinical Evaluation Report
and 8 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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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 10 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 The Medical Device School - From Concept to CE Marking
and 2 more Full details...

Speaking on Pharmaceutical Regulatory Affairs in Asia
and 1 more Full details...

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...

Speaking on Pre-Filled Syringes: End-to-End Processing
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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 works part-time for Philips as a quality, regulatory and standards expert. Koen specializes in health software and views tech regulations through the computational lens. He enjoys...

Speaking on Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
and 1 more 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), Technology Transfer (TT), Quality...

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

Tamsin Dawson

Dr Tamsin Dawson has worked in animal health product development and registration since 2005 and started her career in industry in an analytical method development & validation role. In her...

Speaking on Practical Implementation of GCP in Veterinary Field Studies
and 1 more Full details...

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 Asia
and 1 more Full details...

Speaking on Biotechnology for the Non-Biotechnologist
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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 Pharmaceutical Regulatory Affairs in Russia and the Eurasian Union
and 1 more Full details...

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...

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...

Speaking on Veterinary Pharmaceutical Submissions in the EU
and 1 more Full details...

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...

Speaking on Biotechnology for the Non-Biotechnologist
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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 Development of Combination Products: Critical Interactions
and 3 more Full details...

Eamonn Hoxey

Eamonn Hoxey, is a technical author, trainer and consultant in life science areas including regulatory compliance, quality management, sterility assurance and standards development. Eamonn...

Speaking on Medical Device Single Audit Programme (MDSAP)
and 1 more Full details...

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...

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

Rob Hughes

Rob Hughes has worked in the pharmaceutical industry for more than 35 years.

Rob started his career in control laboratories before gaining accreditation as a “Qualified Person”.

During...

Speaking on An Introduction to Quality Management for Managers
and 2 more Full details...

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 4 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 3 more Full details...

Speaking on The Medical Device School - From Concept to CE Marking
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Speaking on Borderlines between Medicines and Food
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Speaking on Cyber Security for Medical Devices
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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...

Speaking on The Medical Device School - From Concept to CE Marking
and 1 more 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 Pharmacovigilance Aspects of Licensing Agreements
and 10 more Full details...

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...

Speaking on EU Pharmaceutical Regulations & Strategy
and 1 more Full details...

Speaking on Pharmaceutical Packaging, Labelling and Artwork Origination
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Speaking on Veterinary Pharmaceutical Submissions in the EU
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Speaking on Biological Evaluation of Medical Devices
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Speaking on Pharmaceutical Packaging, Labelling and Artwork Origination
Full details...

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...

Speaking on A Practical Approach to Veterinary Vaccine Development and Registration in the EU
and 1 more Full details...

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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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...

Speaking on Sustainable Design and Manufacture for Medical Devices
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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 Advanced Veterinary Pharmacovigilance
and 1 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
Full details...

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,...

Speaking on Stability Testing of Pharmaceuticals and Biopharmaceuticals
and 2 more Full details...

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
Full details...

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...

Speaking on Veterinary Pharmaceutical Submissions in the EU
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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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Speaking on Clinical Overview and Clinical Summary: Creating Effective Marketing Authorisation Application
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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...

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

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...

Speaking on Pre-Filled Syringes: End-to-End Processing
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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...

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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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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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...

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

Speaking on The Common Technical Document
and 2 more Full details...

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 The Common Technical Document
and 5 more Full details...

Speaking on Borderlines between Medicines and Food
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James Visanji

James holds a PhD in Medicine from the University of Manchester, Masters in Clinical Genetics from the University of Sheffield, Chartered Linguist status from the Chartered Institute of Linguists,...

Speaking on Successful Medical Writing
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Christopher Waterhouse

Chris Waterhouse is Managing Director of iDi Pac Ltd, a member of the Packaging Collective Leadership team as well as a former Chairman of the UK Packaging Society.

Chris has over 30 years’...

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

Speaking on Practical Implementation of GCP in Veterinary Field Studies
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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 Pharmaceutical Development of ATMPs
and 1 more Full details...

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...

Speaking on Registration of Veterinary Vaccines in the USA and Canada
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Speaking on The Medical Device School - From Concept to CE Marking
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