Medical Devices

Tina Amini

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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 held the positions of Head of Notified Body and...

Stuart Angell

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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 to the new IVD/Medical Device Regulations, MDSAP...

Elizabeth Baker

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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 combinations, and undertaking the assessment of...

Janette Benaddi

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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 studies in both devices and pharmaceuticals....

Michael Benninger

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Gregory Berman

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Gregory is Head of the Medical Group at Kinneir Dufort, an award-winning research, innovation, design and product development company, with over 30 years’ experience helping companies discover, create, develop and realise tangible new products,...

Will Burton

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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 and biotechnology industry sectors. Prior to...

Dale Charlton

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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 sectors. Dale worked in a technical capacity in basic R&D...

Philip Clay

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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’ experience in toxicology and safety assessment. He is a...

Koen Cobbaert

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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 giving training and lectures and thrives on solving...

Nancy Consterdine

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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 transition to the new IVD/Medical Device Regulations,

Richard Featherstone

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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 consultancy that works exclusively with new and emerging...

Ben Forbes

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Ben Forbes is a Professor of Pharmaceutics at King’s College London. He is currently the Head of the Pharmaceutics Teaching Section and the Drug Delivery Research Group of the Pharmaceutical Science Division. He has a B.Pharm from King’s...

Anders Fuglsang

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Tom Grinnan

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Barbara Grossman

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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 consultancy business (Hawkeye Medical Limited) and built...

Heba Hashem

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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 University), RAC certified in addition to an MBA at...

Mike Holroyd

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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. Catharine’s College, Cambridge. He started his...

David Howlett

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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 led to involvement in projects with focus in...

Jonathan Hughes

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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 diagnostics. He has worked with medical device and...

Janine Ingleby

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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 Hull. She has over 10 years of regulatory and product...

Theresa Jeary

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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 and Medical Device industries and has worked in...

David Jefferys

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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 clinical and academic medicine before spending 20...

Michelle Kelly

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Zuzanna Kwade

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Helen Muirhead

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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 and supports Lung Disease charities. In GSK, Helen...

Ilona Putz

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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 regulatory consultancy for international...

Alain Regard

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Andreas Rothmund

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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 application systems. He started his industrial career in...

Regina Scherließ

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Prof. Dr. Regina Scherließ (*1979) is a professor for Pharmaceutics and Biopharmaceutics, director of the section Pharmacy and chair of the Department of Pharmaceutics at Kiel University, Germany. As such she leads the research unit in...

Jag Shur

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Paul Sim

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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 2013/473/EU dealing with Unannounced Audits. Joining...

Julie Suman

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Dr. Julie D. Suman, R.Ph., Ph.D., is a co-founder and President of Next Breath, LLC, an incubator company located at the UMBC Technology Center. Next Breath, which incorporated in April 2002, is a contract research organisation dedicated to the...

Patrik Thoma

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Jeremy Tinkler

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