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.
DIA is a neutral, global, professional, member-driven association of nearly 18,000 professionals involved in the life cycle management of pharmaceuticals, biotechnology, medical devices, and related health care products. Through our international educational offerings and myriad networking opportunities, DIA provides a global forum for knowledge exchange that fosters the innovation of products, technologies, and services to improve health and well-being worldwide. Headquarters are in Horsham, PA, USA, with offices in Basel, Switzerland, Tokyo, Japan, Mumbai, India, and Beijing, China.