The Regulatory Track at the Nordic Life Science Days 2013

Transcription

1 Uppsala, The Regulatory Track at the Nordic Life Science Days 2013 The Swedish Medical Products, in collaboration with the Norwegian Medicines Agency, the Danish Health and Medicines Authority, the Finnish Medicines Agency, and the European Medicines Agency presents: 1 The Regulatory Track Venue: Stockholm Waterfront Congress Centre Time: Tuesday October 15 10:15 KEYNOTE The Nordic Countries provides a good environment for medical development and innovation Speaker: Christina Åkerman, Director General of the Swedish Medical Products Agency 10:30 Adaptive Licensing New Possibilities and Challenges Speaker: Tomas Salmonson of the MPA, Chairman CHMP, European Medicines Agency 10:50 Clinical Trials The Nordic Perspective Speaker: Audun Hågå, Norwegian Medicines Agency 11:10 Regulatory Challenges for Medical Devices Speaker: Helena Dzojic, Head of Medical Technology, Swedish Medical Products Agency 11:30 Resources for Innovators in Europe Speaker: Constantinos Ziogas, Principal Administrator, SME Office, European Medicines Agency 11:50 Regulatory Challenges for Advanced Therapies Speaker: Paula Salmikangas of Fimea, Vice Chair Committee for Advanced Therapies, European Medicines Agency. 12:10 Panel discussion: The Nordic Countries A Good Environment for Medical Innovation? Christina Åkerman Swedish Medical Products Agency, MPA The Innovation Office Medical Products Agency - Läkemedelsverket Box 26, Uppsala, Sweden Telephone: innovation@mpa.se Internet:

2 Sofia Wallström Anders Blanck Kenneth Chien Hans Winberg The Dental and Pharmaceutical Benefits Agency, TLV The Research-Based Pharmaceutical Industry in Sweden, LIF Professor, Karolinska institutet and Harvard University General Secretary, Leading Healthcare 12:40 End Moderator: Fredrik Hed, Pharmacist and Medical Journalist Presentations and program will be posted on the web site of the Innovation Office at the Swedish Medical Products Agency: 2 The Booth The Regulatory Meeting Point At the exhibition area of the conference, there will be a booth to provide a meeting point for delegates that wish to speak more about regulatory issues. The booth will be staffed by representatives from the regulatory agencies. Please do come by and visit, and meet others interested in regulatory issues. 3 Presenting the Speakers A brief presentation of the people you will meet (in order of appearance). Christina Åkerman Swedish Medical Products Agency Since September 1, 2008 Dr. Åkerman s position is Director General at the Medical Products Agency, Sweden. She is a specialist in Clinical Pharmacology, has a PhD in Clinical Physiology and an Executive MBA General Management from Stockholm School of Economics. Dr. Åkerman is a member of the board at Fouriertransform. During Dr. Åkerman held the position as Marketing Company President of AstraZeneca in the Philippines. Since 1995, she has held senior positions as Project Manager, Medical Director and Marketing Director at Hässle Pharmaceuticals and AstraZeneca Sweden. The Innovation Office, MPA Page 2

3 Tomas Salmonson Chairman, Committee for Medicinal Products for Human Use, European Medicines Agency Tomas Salmonson is currently chair of Committee for Medicinal Products for Human Use, CHMP, at the European Medicines Agency, EMA, and chair of the CHMP Pharmacokinetics Working Party. In addition, he is an ICH Steering Committee Member representing the EU. He holds a position as Senior Scientific Advisor at the Medical Products Agency (MPA), Sweden. Tomas has been a member of the CPMP/CHMP since In parallel, he was Director, Scientific and Regulatory Strategies at the Medical Products Agency (MPA) in Sweden for a number of years. Tomas obtained his PhD from Faculty of Medicine Uppsala University, Uppsala, Sweden in 1990 and an MSc (Pharm.), from Uppsala University, Sweden in Prior to that, he did research at UCSF, San Francisco, USA Audun Hågå Norwegian Medicines Agency Prior to his current position Audun was Deputy Director General in the Norwegian Ministry of Health and Care Services for ten years and he has also worked 6 years in the Norwegian Medicines Agency with pricing and reimbursement as Head of Department. Before his duties as civil servant Audun worked 10 years in the pharmaceutical industry based both in Norway and Sweden. He holds a Cand. Scient degree from the University of Oslo (Norway) in Biology (Zoo-physiology). Helena Dzojic Head of Medical Technology, Swedish Medical Products Agency Helena Dzojic is Head of the Department of Medical Devices with overall responsibility for its activities. The department is responsible for the market surveillance related to the law on medical devices and issuing directives with the support of this legislation. The department represents the Medical Products Agency in various international working groups within the medical device field. Dr. Helena Dzojic received her Degree of Master of Science with a major in molecular biology in 2001 from the Uppsala University, Uppsala, Sweden. She received her Ph.D. degree in clinical immunology from the Uppsala University in May She was recruited to the Medical Products Agency in October The Innovation Office, MPA Page 3

4 Constantinos Ziogas Pricipal Administrator, SME Office, European Medicines Agency Since joining the EMA, Constantinos Ziogas has held several positions, initially as project manager for centralised marketing authorisations applications for biologicals and new chemical entities. Thereafter he served in the Scientific Advice and Orphan Drugs Division where he was responsible for the coordination of European scientific advice on drug development to pharmaceutical companies. Constantinos Ziogas currently works in the SME Office at the European Medicines Agency. Constantinos Ziogas is a graduate in medicine from the Free University Of Brussels where he also completed a training pharmaceutical medicine. Paula Salmikangas Vice Chair, Committee for Advanced Therapies, European Medicines Agency. Dr. Salmikangas is a biochemist by training, with a Ph.D. in muscle cell biology. Her main research work career has been in cell and molecular biology of various inherited diseases. Since 2006, she has been an Adjunct Professor of Biochemistry for the University of Helsinki. Dr. Salmikangas has worked as a senior researcher at Finnish Medicines Agency, Finland since Her main areas of expertise are biological medicinal products, especially cellbased medicinal products and combination products. Dr. Salmikangas has been a member and chair of Cell Products Working Party (CPWP) in the European Medicines Agency (EMA) during 2005 and Since 2009, she has been the Vice-Chair and member of the Committee for Advanced Therapies at the EMA. Sofia Wallström The Dental and Pharmaceutical Benefits Agency, TLV Sofia Wallström is the Director General at the The Dental and Pharmaceutical Benefits Agency in Sweden, TLV. Sofia Wallström has worked several years for the government and during she was responsible for the pharmacy re-regulation in Sweden. She has also investigated pricing, availability and market conditions in the pharmaceutical and pharmacy area. Prior to her position as Director General she held a post as County Director of the provincial government in Västmanland. The Dental and Pharmaceutical Benefits Agency, TLV, is a central government agency whose remit is to determine whether a pharmaceutical product or dental care procedure shall be subsidized by the state or not. We also contribute to quality services and accessibility of pharmacies. The Innovation Office, MPA Page 4

5 Anders Blanck The Research-Based Pharmaceutical Industry in Sweden, LIF Anders Blanck is Director General at The Swedish Association of the Pharmaceutical Industry, LIF. He is also active as a member of the board of Karolinska Institutet, the Swecare Foundation, and the Swedish Anti Corruption Institute. Anders Blanck received a Bachelor of Science (BSc), in International Economics from the Stockholm School of Economics. He has long experience from the Government Offices of Sweden where he worked as the Director General for Health in the Ministry of Health and Social Affairs. Kenneth Chien Professor, Karolinska institutet and Harvard University Dr. Kenneth Chien is an internationally recognized biologist specializing in cardiovascular science, as well as a pioneer in developing new therapeutic strategies to prevent the onset and progression of heart failure. As of January, 2013, Dr. Chien holds an appointment as a professor in Cell and Molecular Biology, and Medicine at the Karolinska institutet in Stockholm, where he leads a team of physicians and scientists on pathways of human cardiogenesis and its implications for regenerative medicine. He will continue his appointment at Harvard as a Visiting Professor, with his lab in Fairchild in Cambridge. He is a member of the Harvard Stem Cell Institute, where he formerly led the university-wide Cardiovascular Stem Cell Biology Program. Prior to his MGH/HMS appointments, Ken directed the Institute for Molecular Medicine at the University of California at San Diego (UCSD) was an adjunct professor of The Salk Institute. Dr. Chien has conducted groundbreaking research focused on the molecular pathways of cardiac development and disease, much of which has been published in the top tier journals in the field of biomedical science, including Cell, Science, and Nature. The Innovation Office, MPA Page 5

6 Hans Winberg General Secretary, Leading Healthcare Hans Winberg is the founder and General Secretary of Leading Healthcare, an academic think tank and foundation, established by the Stockholm School of Economics Leading Healthcare is actively pursuing research in the crossroads between governance, organization and leadership on one hand, and life science and healthcare on the other. Hans Winberg holds a Ph.Lic. from the Stockholm School of Economics. After doing research within the field of Public Organization and Management, Hans worked with Stockholm School of Economics Executive Education for 15 years as a senior executive in different positions. Being interested in bridging academia and practice and having worked with a wide range of actors within health and life sciences, Hans took the initiative of forming the academic think tank Leading Health Care. The Innovation Office, MPA Page 6