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Asian Regulatory Conference Facilitates Greater Harmonization of Regulatory Requirements in Asia Pacific Region

Seoul, Republic of Korea — Mar 14, 2011

DIA, the APEC Harmonization Center, and the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), will host the Asia Regulatory Conference: Asia’s Role in Global Drug Development from April 26-28, 2011 in, Seoul, Republic of Korea. This three-day conference is designed to: 

  • Strengthen cooperation between Asian regulatory authorities and the pharmaceutical industry
  • Facilitate discussion on common issues in the regulatory and technical areas in the Asia Pacific region
  • Encourage greater harmonization of regulatory requirements in the Asia Pacific region

Session topics include:

  • Regional Harmonization
  • Update on ICH Activities, Focus on New Activities
  • Fighting Counterfeit Medicines in Emerging Countries: Addressing Infrastructure and Capacity Gaps
  • Ensuring Quality – Enhance the Approach of Quality Driven by ICH Q8, Q9, Q10, and Q11: What about Practical Implementation?
  • Practical Uses of Common Technical Documents (CTDs) in Asia
  • Early Clinical Development in Asia
  • Late Clinical Development in Asia
  • Establishing the Asia Pacific Region as an Important Partner in Global Pediatric Development
  • Ensuring Quality: Harmonizing and Optimizing Inspection Approach in the Global Environment
  • Ethical Business Practices: Towards Better Marketing Compliance
  • Similar Biotherapeutic Products (SBPs) in Asia: Opportunities and Challenges in Regulatory Evaluation
  • Electronic Submissions and eCTD as Vehicle to Reconcile Differences in Technical Regulatory Requirements
  • Pharmacovigilance: How Do Regulatory Agencies and Industry Work Together to Protect Patients?
  • Good Regulatory Practices, Including Assessment Report, Efficient Use of Certificate of Pharmaceutical Product (CPPs) and Transparency

GCP Site Tour

The Korea Food and Drug Administration (KFDA) is offering international attendees an opportunity to visit the GCP facilities at Seoul National University Hospital to better understand the current status of clinical trial research in Korea.

“Join representatives from more than 20 Asian and ICH regulatory agencies, as well as industry professionals, will  discuss regulatory aspects of ICH, APEC and ASEAN harmonization initiatives, good regula¬tory practices, quality and GMP, global drug development, and pharmacovigilance,” says Program Chair André W. Broekmans, Vice President, Most of World Regulatory Policy & Regulatory Affairs, MSD, The Netherlands.

 

 

 

 

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ABOUT DIA: DIA is the global connector in the life sciences product development process. Our association of more than 18,000 members builds productive relationships by bringing together regulators, innovators and influencers to exchange knowledge and collaborate in an impartial setting. DIA’s network creates unparalleled opportunities for the exchange of knowledge and has the interdisciplinary experience to prepare for future developments. The dedicated efforts of DIA staff, members and speakers enable DIA to provide a comprehensive catalogue of conferences, workshops, training courses, scientific publications and educational materials. DIA is a global community representing thousands of stakeholders working together to bring safe and effective products to patients. DIA is an independent, nonprofit organization with its global center in Washington, D.C., USA; regional offices covering North and South America (Horsham, Penn., USA); Europe, North Africa and the Middle East (Basel, Switzerland); and Japan (Tokyo), India (Mumbai) and China (Beijing). For more information, visit www.diahome.org.