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CONFERENCE DAY 2 Wednesday, 19 September 2012 • Incorporating various regulatory requirements into SOPs: what were the challenges • Ensuring the pharmacovigilance practices are compliant with global safety requirement: how to do this successfully Michal Borawski International Pharmacovigilance Officer, Asia-Pacific Region Sanofi-Pasteur 14:35 Developing and Implementing Pro-Active Pharmacovigilance (PV) Strategies to Ensure Drug Safety • Understanding in-depth the essential components of pharmcovigilance (PV) • Developing and implementing pro-active PV strategies to ensure drug safety: how to manage PV system, safety planning and risk management and mitigation at a high level • Turning the strategies into detailed practical steps • Exploring how to capitalise on the pro-active PV strategies for better drug safety Dr. Ming Ji Senior Medical Director in Clinical Safety Evaluation Global Pharmacovigilance Abbott 15:10 Afternoon Tea and Refreshement Break 15:40 Case Study: The Impact of Ex-Asia Pharmacovigilance Regulations in Bausch + Lomb Asia-Pacific • An overview of the new European Commission Pharmacovigilance Legislation and other regulations – the impact on the safety monitoring of globally registered products within Asia-Pacific • Understanding communication requirements for active substances’ worldwide exposure • Exploring other impacts of Ex-Asia Pharmacovigilance Regulations on the safety monitoring systems in Asia-Pacific • Assessing the strategies to meet ex-Asia Pharmacovigilance Regulations in Asia-Pacific Rachel Wong Global Safety and Vigilance Manager, Asia Pacific Bausch & Lomb 16:15 Case Study: Protecting Pharmaceutical Companies in China from Legal Challenges Pertaining to Drug Safety • Understanding Chinese regulatory requirements: your rights and obligations • Update on current practices of processing legal suits and compensation claims in China • Case study: sharings on how you prepare and protect your companies from legal challenges pertaining to drug safety Dr Joy Li Director Pharmacovigilance & Medical Information, China R&D Bristol-Myers Squibb (China) Investment Co., Ltd. 16:50 Chairman’s Closing Remarks 16:55 Close of Conference Day Two “This conference offers the opportunity for those working in pharmacovigilance to share expertise and learn about best practices and challenge the way they do things.” Pharmacovigilance Manager, MSD PHONE: (65) 6722 9388 • FAX: (65) 6720 3804 • EMAIL: enquiry@iqpc.com.sg • WEB: www.pharmacovigilanceasia.com
WORKSHOPS Monday, 17 September, 2012 WORKSHOP A 0900 – 1200: Monday, 17 September 2012 (inclusive of 30-min refreshment and networking break) Practical steps in preparing for PV inspection To ensure regulatory compliance, inspections are conducted regularly which require much and careful preparation work. Different stakeholders will be involved as well which adds to the complexity. It is critical for the team to be properly prepared and make sure every step is right to lead to a fruitful inspection. Dr. Ming Ji will share through his vast experience in this field the common challenges, and give insights on practical steps to prepare for PV inspection. WORKSHOP AGENDA 0830 Registration 0900 Welcome from Workshop Leader 0905 Understanding PV inspections • purposes • inspection documents • key requirements • reporting timeline 0930 What to prepare • before • through and • after an inspection 1000 Preparing documents • what are they • which sections require special attention • acquiring information from departments 1030 Refreshment and Networking Break 1100 Developing good communications strategies • why communications are important • common challenges and impact on inspection results • what works best 1130 Conducting a mock inspection 1200 End of workshop About your workshop leader: Dr. Ming Ji, MD, MS. Senior Medical Director, Global Pharmacovigilance Abbott Dr. Ming Ji had extensive experience in clinical drug safety, pharmacovigilance and clinical pharmacology. Prior to his current post, Dr. Ji served as medical director at Pharmacovigilance Department of TAP Pharmaceutical Inc., executive director at Global Safety of Amgen Inc., and medical monitor in Clinical Development of Wyeth. WORKSHOP B 1400 – 1700: Monday, 17 September 2012 (inclusive of 30-min refreshment and networking break) Achieving compliance with various country regulations in Asia while meeting company global safety requirements As Asia presents the largest growth opportunity for pharmaceutical industry, many are taking foothold in Asia to gain market share. One major challenge faced is to ensure compliance with various country regulations, which are rapidly changing and evolving. In addition, the company’s global safety requirements add to the burden of pharmacovigilance professionals. In this workshop, you will learn how to effectively comply with various country regulations in Asia while meeting company’s global safety requirements. WORKSHOP AGENDA 1330 Registration 1400 Welcome from Workshop Leader 1405 Understanding PV regulations in Asia • What are PV regulatory requirements in Asian countries • How PV regulations differ in various countries • Implications for PV managers 1430 Achieving compliance in Asia • what areas to look out for • ensuring due diligence • conducting mock inspections internally 1500 Making compliance simple • SOPs to incorporate regulatory requirements • company global safety requirements 1530 Refreshment and Networking Break 1600 Case study of Sanofi-Pasteur • what it does to comply with Asian regulations and company global safety requirements • common challenges and impact on PV compliance • strategies to overcome the challenges 1630 Hands-on application • how your PV practices can be improved • will Sanofi-Pasteur’s way work for you • Modifying your PV practices to make compliance reliable and simple 1700 End of workshop This workshop will be led by an industry expert. Look out for our workshop leader announcement at www.pharmacovigilanceasia.com. PHONE: (65) 6722 9388 • FAX: (65) 6720 3804 • EMAIL: enquiry@iqpc.com.sg • WEB: www.pharmacovigilanceasia.com
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