Showing posts with label global regulatory affairs. Show all posts
Showing posts with label global regulatory affairs. Show all posts

Friday, October 11, 2013

The founder of the European Medicines Agency (EMA), Fernand Sauer, will give the keynote speech at 10th Annual Meeting DIA Japan.

10th Annual Meeting DIA Japan 2013
One Month Left to Book Your Seat to Hear Fernand Sauer and Other Prominent Speakers
The founder of the European Medicines Agency (EMA), Fernand Sauer, will give the keynote speech at 10th Annual Meeting DIA Japan.
Fernand Sauer
Mr. Sauer joined the European Commission in Brussels in 1979 and was involved in European pharmaceutical harmonization, playing a key role in launching the harmonisation of regulatory requirements (ICH) with the US and Japan. In 1994 he created the EMA and became its first Executive Director until 2000. He is currently a member of the French Academy of Pharmacy and, as Honorary Director General of the European Commission, he continues to advise European Institutions and EU agencies on health and pharmaceutical issues. In 2006 Mr. Sauer received the DIA Distinguished Career Award.

The meeting, to be held from November 6-8, will bring together academia, regulatory agencies, industry, and patients to discuss how to move ahead with the discovery and fostering of innovative drugs.
The wide variety of sessions across six tracks will cover topics such as the role of academic research organizations, regenerative medicine, companion diagnostics, and discussion of the current issues in ICH featuring representatives from global regulators. Attendees will also enjoy high profile networking opportunities.
Session highlights include:
  • Drug Development Through Collaboration with ARO and Future
  • Risk-based Approach to Monitoring
  • Multiregional Drug Development
  • Asia Town Hall
  • Effective Consultation Strategy in Global Development based on Consultation Examples from Japan and Other Regions
  • Globalization of ICH Guidelines
  • Current Status and Perspectives for the Development of Companion Diagnostics and Personalized Medicine
  • The Regulation, Development, and Future of Biosimilars
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Thursday, October 3, 2013

DIA's Annual Canadian Meeting: New Reality/New Frontiers

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DIA's Annual Canadian Meeting: New Reality/New Frontiers
DIA Members Save $150. Early-bird expires October 7.
Collaborate with key stakeholders: boost awareness and deliver value to today’s patient reality driving change in drug development and regulations. At this Annual Meeting, stakeholders from industry, regulatory agencies, academic researchers, patient and patient advocacy groups will have the opportunity to work together to recognize the challenges faced by the industry and regulators in drug development, market access, and regulations in Canada. 
Opening Remarks:
Kathryn McDade
Assistant Deputy Minister of the Health Products and Food Branch
Health Canada
Plenary Sessions:
    • International Regulatory Cooperation
           - Trends and Impacts
           - Stakeholder Perspective
Register 3, Get the 4th FREE!
Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time.
Table Top Exhibits:
Showcase your products and services to key decision makers in Canada. View Application Now.
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Friday, February 22, 2013

4th Pharmacovigilance Conference in Bangalore March 8-9

4th Pharmacovigilance Conference | New Insights into Current Pharmacovigilance Challenges | March 8-9 | Bangalore, India
Register Today!
The date of the 4th Pharmacovigilance Conference in India is fast approaching. Take this opportunity to discuss the latest global challenges in drug safety with professionals worldwide.

Professionals attending the two-day conference, to be held in Bangalore from March 8-9, will learn about current global safety reporting requirements for prescription and over-the-counter drugs and discuss new, pragmatic approaches to pharmacovigilance.

Other key topics will include the regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan, and identifying best practices for quality assurance in post-marketing pharmacovigilance and clinical safety.
EXHIBITING OPPORTUNITY
Download the application for a tabletop display at the event.
Other events
of Interest
Download the India Calendar of Events
5th Annual Meeting | DIA CHINA 2013 | May 12-15, 2013 | Beijing, China
Conference Highlights
  • Updates on recently released GPvP Modules by EMA
  • Japanese model of EPPV – a way forward for other Asian countries
  • Challenges in authoring PSUR for generic manufacturers
  • An insight into Drug Induced Liver Injury (DILI)
  • Global regulatory compliance: challenges and the way forward
  • Safety regulations in emerging Middle East region
  • Efficient management of literature searching
  • Enhanced productivity and quality through process re-engineering; case studies
  • Global outsourcing trends in PV – Indian potential and challenges by China, Taiwan, and Latin America
  • RSI management – best practices to safeguard against pitfalls
  • Attrition and manpower stability; KPO perspective
  • Technology-watch against safety hazard of spurious and adulterated drugs
  • Training; A Formality or a Reality – an industry insight
  • Panel discussion: compensation for trial related injuries
This Pharmacovigilance Conference is perfect for professionals with experience in clinical safety and who are involved in:
  • Pharmacovigilance
  • Clinical research
  • Risk management
  • Compliance
  • Medical information
  • Regulatory affairs
  • Academia
  • Pharmacology
To know more, contact Manoj.Trivedi@diaindia.org
Thank You to our Media Partner
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