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Medical Device School

2019 Sold Out!

10 - 12 November 2020

Radisson Blu Edwardian Grafton, London

Medical Device School Speakers

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Victoria Cavendish

 

Victoria Cavendish is a highly skilled Clinical Affairs specialist with a solid understanding of the associated Quality and Regulatory landscape gained over 15 years within academia, medical device manufacturing companies, and Clinical Research Organisations. Victoria has held senior positions at various medical device companies such as Premier Research, Reckitt Benckiser and Novartis Pharma AG managing successful clinical teams.

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Phil 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 experience in toxicology and safety assessment. He is a BSI committee member on CH/194  (Biological evaluation of medical devices).

He established his reputation as a genetic toxicologist working within the agrochemical, chemical and pharmaceutical industries. He has contributed to many expert panels, helping to shape the testing guidelines and strategies in place today.

More recently, this experience and depth of understanding has been applied to designing safety assessment programmes for medical devices and consumer healthcare products for global FMCG businesses.

 

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Howard Dobbs

Howard Dobbs is the Managing Director of Howard Dobbs Consulting Ltd, which provides regulatory affairs and quality assurance services for the medical devices industry.  Previously, he has worked in the UK and the US for both large and small companies.

Today, he specializes in the preparation and review of design dossiers and clinical evaluations. He is chairman of the BSI technical committee on surgical implants. While recognizing the need for medical devices to be as safe as possible, he remains not yet convinced about the cost-effectiveness of unannounced audits and the scrutiny procedure.

 

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Clive Powell

Clive Powell has worked for ABHI since 1990 specialising in medical device regulation and ethical compliance issues. He co-ordinates the work of ABHI’s Technical Policy Group and Legal Issues and Compliance Committee which are the main forums for developing the association’s policy and positions on these matters. He also deals with quality management systems and sterilisation and microbiology through the relevant groups.

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Mika Reinikainen

Mika has more than 30 years' of experience managing European medical regulatory affairs in industry, as healthcare legal counsel and as a regulatory consultant. He has also been involved directly in the development of the Medical Devices Directives (as Consultant to the European Commission and through trade associations) and of technical standards (former Chairman of CEN TC 257). 

 

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Matthew Theobald

Matthew has over 23 years' experience working at strategic, site and project levels with organisations across Europe and the US. He has worked in both medical device development and Quality Management. Matthew has presented at conferences throughout Europe, delivered more than 50 training events, co-authored two books about Human Factors for Medical Devices, including “How Humans Factor (in medical device design)” and one on project leadership.

 

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Sinan Utku

Sinan Utku is Special Counsel at Covington & Burling LLP. He focuses on international intellectual property law. His practice includes intellectual property transactions and licensing, the drafting of original patent applications, patent prosecution, drafting patent opinions, technology transfers and client counseling, especially in the areas of US and UK patent law. He has had significant experience in the technology areas of pharmaceuticals, medical devices, biotechnology, telecommunications, fiber optics, cryptography, computer software, business methods, and the electrical arts generally.