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CCH - Congress Center Hamburg

Apr 06, 2016 8:00 AM - Apr 06, 2016 12:30 PM

Am Dammtor / Marseiller Str., 20355 Hamburg, Germany

3rd ICH Information Day

Speakers

Martin  Harvey Allchurch, LLM

Martin Harvey Allchurch, LLM

Head of International Affairs, European Medicines Agency, Netherlands

Martin Harvey is Head of International Affairs at the European Medicines Agency (EMA), EU. He first joined the EMA legal team after serving as a European affairs consultant in Brussels. He headed the Office of the Executive Director, served as Head of Communication, and then moved to the Agency's International Affairs team. He took an 18-month career break with Unitaid, the WHO-hosted partnership dedicated to innovation in global health from 2019-2020. Martin has served on the DIA Advisory Council for EMEA; and as program advisor for DIA's EuroMeeting and Global Annual Meeting. He holds law degrees from the University of Dundee (UK) and the Vrije Universiteit Brussels (Belgium). He is a Fellow of DIA since 2018.

Lenita  Lindström, LLM

Lenita Lindström, LLM

ICH Assembly Chair and Senior Expert, European Commission, European Commission, Belgium

Mrs Lindström is the Chair of the ICH Assembly. She is working as a Senior Expert in the Directorate General for Health and Food Safety (DG SANTE) in the European Commission where she is in charge of international relations in the field of pharmaceuticals. Mrs Lindström has over 20 years experience in the European Commission, including over 10 years in the field of pharmaceuticals. She holds a Master of Laws degree from the University of Helsinki, Finland.

Tomas  Salmonson, DrMed, PhD

Tomas Salmonson, DrMed, PhD

Partner, Critical Path Institute, United States

Tomas Salmonson, M.Sc., PhD, brings outstanding experience and expertise from a long career in the regulation of medicines both on a national and European level to his new role. A pharmacist by training, he is currently senior scientific advisor at the Swedish Medical Products Agency in Uppsala, Sweden. He has been a member of the Committee for Medicinal Products for Human Use (CHMP) for more than 12 years. In 2012, Dr Salmonson was elected chair of the CHMP; he was Vice chair of the CHMP from 2007 till 2012. Tomas has been DIA Advisory Council of Europe Member during 1996-2002 and a speaker in over 20 DIA Events.

Toshiyoshi  Tominaga, PhD

Toshiyoshi Tominaga, PhD

Project Professor, Keio University Hospital, Japan

Toshi Tominaga is an ex-official at Japan’s Ministry of Health, Labor and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA), and now with Japan Self-Medication Industry (JSMI). His responsibilities as regulator included drug review, research promotion, and international cooperation. His experience includes secondment to USFDA and to Osaka City Medical School as professor for clinical development. As Senior Advisor to the President of JSMI, he is currently responsible for international activities in general of the organization and also serves as Secretary-General for Asia-Pacific Self-Medication Industry, which consists of seven national OTC manufacturers associations as well as several OTC firms.

Steven  Teerenstra, PhD, MSc

Steven Teerenstra, PhD, MSc

Statistician, Medicines Evaluation Board, Netherlands

Corina Dana Dota, MD

Corina Dana Dota, MD

AZ ECG Centre Director, AstraZeneca R&D Molndal, Sweden

Jan Willem  van der Laan, PhD

Jan Willem van der Laan, PhD

Senior Assessor Pharmacology and Toxicology , Medicines Evaluation Board, Netherlands

In 1980 Jan Willem van der Laan joint the National Institute for Public Health and the Environment (RIVM, Bilthoven) as a biochemist and pharmacologist on CNS targets. In 1990 is he assessor Pharmacology and Toxicology of Human Pharmaceuticals at the and later, since 2011 directly for the Medicines Evaluation Board, located in Utrecht, the Netherlands. He is chair of the EMA/CHMP Safety Working Party since 2012. His contributions to the International Council on Harmonization started in 1993 on Carcinogenicity Testing. In 2012 the discussions on this topic have been restarted to reduce the number of 2-yr studies in rodents, and Jan Willem is Regulatory Chair on this process.

Filip  Mussen, PhD

Filip Mussen, PhD

Vice President, Regional Regulatory Affairs, Janssen R&D, Pharmaceutical Companies of Johnson & Johnson, Belgium

Filip Mussen is currently Vice President, Regional Regulatory Affairs at Janssen Research & Development (Johnson & Johnson). His team is responsible for all regulatory activities in Asia-Pacific, Europe, Middle East and Africa, and Latin-America. Filip is based in Beerse, Belgium. Filip Mussen joined Johnson & Johnson in 2008 in the Global Regulatory Affairs – Neurosciences department. From 2011 to 2014 he was the Head of the GRA Global Labeling Centre of Excellence. Previously Filip Mussen worked at Merck & Co. (Merck Sharp & Dohme). Filip Mussen obtained a Master of Science degree in Pharmacy from the University of Gent (Belgium), and his PhD from the Welsh School of Pharmacy at Cardiff University (UK).

Dawn  Ronan

Dawn Ronan

Regulatory & Scientific Manager, ICH Secretariat, Switzerland

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