25th Annual EuroMeeting
4-6 March 2013 | AmsterdamThe EuroMeeting 2013 transcends borders and boosts international relations by drawing attention to contemporary issues outside Europe such as in the USA, Brazil, China, Japan and India; and focusing on contemporary issues in the interface between those countries and Europe.
Globalisation Track
Co-Chairs:- Christer Backman, Member CMDh, EU Coordinator and Senior Expert, Medical Products Agency, Sweden
- Ning Xu, Executive Director, Head of CDS, Covance Pharmaceutical R & D, China
Title: SAFE, EFFECTIVE AND AFFORDABLE MIDICINAL PRODUCTS FOR A GLOBAL POPULATION
Chair:Marijke Pubben
Vice President EMEA Quality
Merck Sharp & Dohme B.V., Netherlands
Description:
It is in the best global public interest to accelerate availability of affordable drug products to the world's patients, consumers and healthcare providers. To enable this, regulators and industry are looking for ways to collaborate, build trust, mutual confidence and common understanding within their own community and amongst each other. This session will provide opportunities and challenges from industry and regulators to drive towards this promising future.
Presentation(s) & Speaker(s):
Building a Global Quality Culture
Marijke Pubben
Vice President EMEA Quality
Merck Sharp & Dohme B.V., Netherlands
International Cooperation on GxP/GCP Inspections
Tor Graberg
Head of Inspections Unit
Medical Products Agency (MPA), Sweden
Improving Site Selection and Regulatory Transparency through Global Infrastructure Mapping and Collaborative Analytics
Gustavo L.F. Kesselring, MD
Executive Director Latin America
ViS Research Institute, Brazil
Title: INTERNATIONAL COLLABORATION IN THE REVIEW OF GENERIC DRUGS
Chair:Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium
Description:
With the globalisation trend, an increasing number of generic medicines manufacturers are keen to introduce their products at global scale. For health authorities, a need for fast supply of medicinal products from other markets may occur in case of unexpected shortages in their region. Single development program and more harmonised assessments of generic medicinal products between various markets in order to avoid unnecessary duplications of effort shall be discussed among the authorities and industry.
Presentation(s) & Speaker(s):
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- EGA proposal
Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- View of the CMDh
Peter Bachmann, DrSc
Senior Expert; Chair, Coordination Group for Mutual Recognition and Decentralise
Federal Institute for Drugs and Medical Devices, Germany
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- Health Canada perspective
Mike D. Ward
Manager, International Programs Division
Health Canada, Canada
Chair:Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium
Description:
With the globalisation trend, an increasing number of generic medicines manufacturers are keen to introduce their products at global scale. For health authorities, a need for fast supply of medicinal products from other markets may occur in case of unexpected shortages in their region. Single development program and more harmonised assessments of generic medicinal products between various markets in order to avoid unnecessary duplications of effort shall be discussed among the authorities and industry.
Presentation(s) & Speaker(s):
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- EGA proposal
Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- View of the CMDh
Peter Bachmann, DrSc
Senior Expert; Chair, Coordination Group for Mutual Recognition and Decentralise
Federal Institute for Drugs and Medical Devices, Germany
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- Health Canada perspective
Mike D. Ward
Manager, International Programs Division
Health Canada, Canada
Title: SFDA SESSION - GMP IN CHINA
Chair:Ning Xu, MD,MBA
Vice President, Head of Clinical Development Service
Covance Pharmaceutical R&D (Beijing), China
Presentation(s) & Speaker(s):Huiping Chen
Senior Engineer, Center for Drug Certification
State Food and Drug Administration (SFDA), China
Jiahui Ye
Section Chief, Drug Safety Inspection Department
State Food Drug Administration, China
Chair:Ning Xu, MD,MBA
Vice President, Head of Clinical Development Service
Covance Pharmaceutical R&D (Beijing), China
Presentation(s) & Speaker(s):Huiping Chen
Senior Engineer, Center for Drug Certification
State Food and Drug Administration (SFDA), China
Jiahui Ye
Section Chief, Drug Safety Inspection Department
State Food Drug Administration, China
Title: INTERNATIONAL COOPERATION OF GLOBAL REGULATORS
Chair:Marie Allison Dray, MA,MBA
President
International Regulatory Affairs Group LLC, United States
Description:Heads of Regulatory Agencies have increased their cooperation and communication with each other over the past decade and have shared their experiences at DIA Euro and Annual meetings for more than 8 years. An interested international following has gathered to hear each annual update. This year’s invited speakers will include: Professor Guido Rasi, Ex Director, EMA and Dr. Margaret Hamburg (or designee), Commissioner of the US Food and Drug Administration. A third speaker will be selected from either another regulatory agency or a regulatory stakeholder organization.
Learning Objective(s):1. Present the status of the formal arrangements among regulators that allow exchange of information. 2. Share current information on inter - Agency dialogue and cooperative activities. 3. Encourage audience participation, comments and feed-back to regulators.
Presentation(s) & Speaker(s):FDA Perspective
Murray M. Lumpkin, MD,MSc
Commissioner's Senior Advisor and Representative for Global Issues, OC
FDA, United States
National Authority Perspective
Aginus A. W. Kalis, MD
Executive Director
Medicines Evaluation Board, Netherlands
Chair:Marie Allison Dray, MA,MBA
President
International Regulatory Affairs Group LLC, United States
Description:Heads of Regulatory Agencies have increased their cooperation and communication with each other over the past decade and have shared their experiences at DIA Euro and Annual meetings for more than 8 years. An interested international following has gathered to hear each annual update. This year’s invited speakers will include: Professor Guido Rasi, Ex Director, EMA and Dr. Margaret Hamburg (or designee), Commissioner of the US Food and Drug Administration. A third speaker will be selected from either another regulatory agency or a regulatory stakeholder organization.
Learning Objective(s):1. Present the status of the formal arrangements among regulators that allow exchange of information. 2. Share current information on inter - Agency dialogue and cooperative activities. 3. Encourage audience participation, comments and feed-back to regulators.
Presentation(s) & Speaker(s):FDA Perspective
Murray M. Lumpkin, MD,MSc
Commissioner's Senior Advisor and Representative for Global Issues, OC
FDA, United States
National Authority Perspective
Aginus A. W. Kalis, MD
Executive Director
Medicines Evaluation Board, Netherlands
Title: MNC’S EXPANSION IN EMERGING MARKETS: OPPORTUNITIES AND CHALLENGES
Chair:Xiaoxiang Chen
Vice President
Boehringer Ingelheim Shanghai Pharm. Co. Ltd, China
Description:Globalisation is one of the drivers that can bring the new drug to the global market faster, especially the emerging and developing market. To further speed up the drug development the industry, regulators, and academia are working together trying to harmonise regulations, to standardize quality, to overcome cultural differences, to better understand various markets, and to drive cross-national communication and collaboration. There are still a lot of challenges in the process of globalisation but a good understanding and managing of those challenges will turn them into opportunities for more successful drug development to save the limited resources, promote common global harmonization, and enhance healthcare for the benefit of patients.
Presentation(s) & Speaker(s):Resizing the Global Contract R&D Services Market
Stella Stergiopoulos
Project Manager
Tufts Center for the Study of Drug Development, United States
Clinical Trial Landscape in Asia: Focus and global connection
Yan Wu
General Manager, Division of Medical and Drug Development
Daiichi Sankyo (China) Holding Co., LTD, China
Speed Up Clinical Development Programmes in China though Robust Site Expansion and Development
QingAn Jiao, MD,MSc
Head of Clinical Operations, Asia Pacific
Roche Product Development In Asia Pacific, China
Chair:Xiaoxiang Chen
Vice President
Boehringer Ingelheim Shanghai Pharm. Co. Ltd, China
Description:Globalisation is one of the drivers that can bring the new drug to the global market faster, especially the emerging and developing market. To further speed up the drug development the industry, regulators, and academia are working together trying to harmonise regulations, to standardize quality, to overcome cultural differences, to better understand various markets, and to drive cross-national communication and collaboration. There are still a lot of challenges in the process of globalisation but a good understanding and managing of those challenges will turn them into opportunities for more successful drug development to save the limited resources, promote common global harmonization, and enhance healthcare for the benefit of patients.
Presentation(s) & Speaker(s):Resizing the Global Contract R&D Services Market
Stella Stergiopoulos
Project Manager
Tufts Center for the Study of Drug Development, United States
Clinical Trial Landscape in Asia: Focus and global connection
Yan Wu
General Manager, Division of Medical and Drug Development
Daiichi Sankyo (China) Holding Co., LTD, China
Speed Up Clinical Development Programmes in China though Robust Site Expansion and Development
QingAn Jiao, MD,MSc
Head of Clinical Operations, Asia Pacific
Roche Product Development In Asia Pacific, China
Title: ENVIRONMENTAL CONSIDERATIONS IN PRODUCTION OF MEDICINAL PRODUCTS
Chair(s):Sharon Evans
Drug Information Association (DIA Europe), Switzerland
Description:ENVIRONMENTAL CONSIDERATIONS IN PRODUCTION OF MEDICINAL PRODUCTS
Presentation(s) & Speaker(s):Pharmaceuticals in the Environment: Risk assessment and global relevance
Anette Küster
Environmental Risk Assessor
Federal Environment Agency, Germany
Presentation
Charlotte Unger
Environmental Manager
Medical Products Agency (MPA), Sweden
Chair(s):Sharon Evans
Drug Information Association (DIA Europe), Switzerland
Description:ENVIRONMENTAL CONSIDERATIONS IN PRODUCTION OF MEDICINAL PRODUCTS
Presentation(s) & Speaker(s):Pharmaceuticals in the Environment: Risk assessment and global relevance
Anette Küster
Environmental Risk Assessor
Federal Environment Agency, Germany
Presentation
Charlotte Unger
Environmental Manager
Medical Products Agency (MPA), Sweden
Title: ASIAN STRATEGY OF THE USA, EUROPE AND JAPAN
Chair:Nobumasa Nakashima
Director, Office of International Programs
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Description:ICH, GHTF, and other harmonization activities are compared. Each initiative has slightly different objectives and approach for harmonization. Based on the comparison, future possibilities of the global regulatory harmonization are discussed.
Learning Objective(s):(1) To understand how leading international regulatory harmonization initiatives are functioning (2) To discuss future directions of harmonization activities
Presentation(s) & Speaker(s):The Efforts in FDA Asian Offices to Secure Quality of Drugs
Ira Wolf, MA
Japan Representative
PhRMA, Japan
Challenges to Asian Companies to Comply with European Legislation on (Traditional) Herbal Medicinal Products
Werner Knoess, DrSc
Chair of the Committee on Herbal Medicinal Products (CHMP)
BfArM, Germany
PMDA International Vision and Cooperation with Asian Countries
Shinobu Uzu
Office Director, Office of New Drug I
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Chair:Nobumasa Nakashima
Director, Office of International Programs
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
Description:ICH, GHTF, and other harmonization activities are compared. Each initiative has slightly different objectives and approach for harmonization. Based on the comparison, future possibilities of the global regulatory harmonization are discussed.
Learning Objective(s):(1) To understand how leading international regulatory harmonization initiatives are functioning (2) To discuss future directions of harmonization activities
Presentation(s) & Speaker(s):The Efforts in FDA Asian Offices to Secure Quality of Drugs
Ira Wolf, MA
Japan Representative
PhRMA, Japan
Challenges to Asian Companies to Comply with European Legislation on (Traditional) Herbal Medicinal Products
Werner Knoess, DrSc
Chair of the Committee on Herbal Medicinal Products (CHMP)
BfArM, Germany
PMDA International Vision and Cooperation with Asian Countries
Shinobu Uzu
Office Director, Office of New Drug I
Pharmaceuticals and Medical Devices Agency (PMDA), Japan
