Life Sciences Faculty

The following expert presenters are scheduled to present our courses:

Speaking on Biotechnology for the Non-Biotechnologist
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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...

Speaking on Biotechnology for the Non-Biotechnologist
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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...

Speaking on Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products
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Rachel Anderson

Rachel is a University of Aberdeen graduate with an honours degree in Pharmacology and a Masters degree in Drug Discovery and Development.  Post-degree, Rachel joined Charles River Laboratories,...

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

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 UK Conformity Assessed (UKCA) Marking for Medical Devices
and 7 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 11 more Full details...

Speaking on Delivery of Biologics to the Nasal Cavity
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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 1 more Full details...

Annette Callaghan

A quality management professional, chartered biologist and member of the Royal Society of Biology, with over 35 years’ experience in the medical device, pharmaceutical, biotechnology and food...

Speaking on Sterilization of Medical Devices
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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...

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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Koen Cobbaert

Koen Cobbaert works for Philips as a quality, regulatory, and standards expert. Through trade associations COCIR and DITTA, he represents the industry at the European Commission and the...

Speaking on Medical Device Software: Complying with the EU MDR, EU IVDR & FDA Regulations
and 1 more Full details...

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 2 more Full details...

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...

Speaking on Understanding Pharmacovigilance Regulations in APAC
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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...

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

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...

Speaking on Data Integrity Auditor Master Class
and 1 more Full details...

Speaking on A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products
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Speaking on Delivery of Biologics to the Nasal Cavity
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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...

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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Joanne Flitcroft

Joanne Flitcroft 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...

Speaking on Pharmacovigilance Aspects of Licensing Agreements
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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 1 more Full details...

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...

Speaking on Biotechnology for the Non-Biotechnologist
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Susanne Hall

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

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

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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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,...

Speaking on Smart Packaging and Electronic Patient Information
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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 The Medical Device School - From Concept to CE Marking
and 2 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 Navigating EU and FDA Regulations for Drug/Device and Device/Drug Combination Products
and 1 more Full details...

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,...

Speaking on Pharmaceutical Regulatory Affairs in Africa
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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 Pharmaceutical...

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 2 more Full details...

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...

Speaking on Metrics and Earned Value in Clinical Research Projects
and 1 more Full details...

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...

Speaking on The Medical Device School - From Concept to CE Marking
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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. As...

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 11 more Full details...

Speaking on A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK
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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 2 more Full details...

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...

Speaking on Drug Discovery: A Step-by-Step Introduction
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Siew Man Phang

Ms. Siew Man Phang is a registered pharmacist in Malaysia, brings over 7 years of
pharmacovigilance and regulatory expertise. She has served as QPPV for multinational
pharmaceutical, generic, and...

Speaking on Understanding Pharmacovigilance Regulations in APAC
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Mardon McFarlane

Mardon McFarlane is a co-founder of a consultancy, Taxo Bioscience, that specialises in supporting pre-clinical and clinical stage biotech companies, by ensuring they make the correct, impactful...

Speaking on Biotechnology for the Non-Biotechnologist
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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
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Speaking on Stability Testing of Pharmaceuticals and Biopharmaceuticals
and 2 more Full details...

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...

Speaking on Pharmaceutical Regulatory Affairs in Africa
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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
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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 Understanding Computer System Validation (CSV)
and 2 more 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
and 1 more Full details...

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 The Animal Health Summer School: Working Through Veterinary Drug Development in the EU and USA
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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...

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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Ian Sealey

Ian Sealey graduated with a BEng (Hons) in Medical Engineering in 2003 and, after a taking a year out to study for a Graduate Diploma in Law, held health-related engineering and policy roles in...

Speaking on A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK
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Speaking on Delivery of Biologics to the Nasal Cavity
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Speaking on A Regulatory Update on the Medical Device and In-Vitro Diagnostic Regulations in the EU and UK
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Speaking on Regulatory Strategies for Orphan Drugs
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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...

Speaking on Delivery of Biologics to the Nasal Cavity
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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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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...

Speaking on Understanding Pharmacovigilance Regulations in APAC
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Philip Webber

After obtaining a degree in Natural Sciences (Genetics) from Cambridge University (UK) and a PhD in molecular biology from Warwick University (UK), Philip joined Dehns in 1992. He is a qualified...

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 The Common Technical Document
and 8 more Full details...

Paula Wittels

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

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

Speaking on Understanding Pharmacovigilance Regulations in APAC
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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...

Speaking on Understanding Pharmacovigilance Regulations in APAC
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