The following expert presenters are scheduled to present our courses:
Speaking on A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
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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...
Speaking on Drafting Commercial Contracts for the Pharmaceutical Industry
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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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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 Drug/Device and Device/Drug Combinations in the EU and USA
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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...
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...
Speaking on The Pharma Mini MBA
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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 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 7 more Full details...
Speaking on A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
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Speaking on Drafting Commercial Contracts for the Pharmaceutical Industry
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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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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 Effective Training Skills in the Pharma Industry
and 17 more Full details...
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...
Speaking on Sterilization of Medical Devices
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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...
Speaking on Drafting Commercial Contracts for the Pharmaceutical Industry
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Speaking on A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
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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 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 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...
Speaking on Biological Evaluation of Medical Devices
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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...
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 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...
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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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 Commercial Contracts for the Pharmaceutical Industry
and 1 more Full details...
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 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 An Introduction to ISO 22716 - GMP for Cosmetic Products
and 2 more Full details...
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...
Speaking on Drafting Commercial Contracts for the Pharmaceutical Industry
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Speaking on A Practical Approach to Developing the CMC Package for Veterinary Pharmaceutical Products
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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 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 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...
Speaking on Pharmacovigilance Aspects of Licensing Agreements
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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 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 Medical Writing for Medical Devices
and 1 more Full details...
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 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...
Speaking on Pre-Filled Syringes: End-to-End Processing
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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 Medical Device Regulation in the Eurasian Union, Russia and the CIS
and 1 more Full details...
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 Medical Device Regulations in the Middle East and North Africa
and 1 more Full details...
Speaking on A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
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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...
Speaking on Consultative Selling for Pharma Professionals
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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, 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 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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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, 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...
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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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 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 3 more Full details...
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 1 more Full details...
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 Clinical Research - A Different Approach to Successful Project Delivery
and 1 more Full details...
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 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....
Speaking on Cyber Security for Medical Devices
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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, 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...
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 Regulatory Affairs for Support Staff
and 2 more Full details...
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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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...
Speaking on Understanding Pharmacovigilance Regulations in APAC
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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...
Speaking on Biotechnology for the Non-Biotechnologist
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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,...
Speaking on Veterinary Pharmaceutical Submissions in the EU
and 1 more Full details...
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....
Speaking on Biological Evaluation of Medical Devices
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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 In the Light of Annex 1: Use of Barrier Systems for Aseptic Pharmaceutical Manufacturing
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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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Senior Regulatory Affairs Manager at Accestra Consulting
Speaking on Navigating China’s API Regulations: An Essential Guide to DMF Registration
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Fred Nicolle is a UK and European qualified patent attorney (CPA, EPA) at Simmons & Simmons. He has over 15 years experience specialising in patent prosecution and contentious matters for...
Speaking on Drafting Commercial Contracts for the Pharmaceutical Industry
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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 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 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...
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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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...
Speaking on The Pharma Mini MBA
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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 Active Pharmaceutical Ingredients (APIs)
and 2 more Full details...
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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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 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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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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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 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...
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....
Speaking on Drafting Commercial Contracts for the Pharmaceutical Industry
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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...
Speaking on Delivery of Biologics to the Nasal Cavity
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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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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...
Speaking on Pre-Filled Syringes: End-to-End Processing
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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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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...
Speaking on Delivery of Biologics to the Nasal Cavity
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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...
Speaking on Delivery of Biologics to the Nasal Cavity
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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...
Speaking on A Regulatory Update on Animal Feed and Feed Additives in the EU, USA and China
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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...
Speaking on Artificial Intelligence and Machine Learning Powered Signal Management
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Speaking on Robotics and Digitalization in Aseptic Pharmaceutical Manufacturing
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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...
Speaking on Drafting Commercial Contracts for the Pharmaceutical Industry
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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 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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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...
Speaking on Drafting Commercial Contracts for the Pharmaceutical Industry
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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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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 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...
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 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 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 Development of Combination Products: Critical Interactions
and 3 more Full details...
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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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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RA & PV Director at Accestra Consulting
Speaking on Understanding Pharmacovigilance Regulations in APAC
and 1 more Full details...
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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