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Dear Colleague, Asia presents the greatest growth opportunities in pharmaceutical industry. Increasing drug consumption, R&D activities and awareness of drug safety issues have led to a rise in drug safety and pharmacovigilance alerts in Asia. Asia has seen major product recalls in recent years, such as the recall of Augmentin in China in 2011. This has led to regulatory authorities across Asia to tighten regulations to safeguard the consumer health, and implement more comprehensive processes to ensure due diligence. These new requirements place significant pressure on pharmacovigilance professionals. In addition, the diverse and often ambiguous regulatory requirements across the region, and the relative infancy of pharmacovigilance of the region add to the challenge faced. Regulatory authorities and pharmacovigilance professionals need to stay up-to-date with regulatory updates, key PV strategies and processes to ensure drug safety. 3rd Annual Pharmacovigilance Asia has established itself as the perfect platform connecting regulators and pharmacovigilance professionals. This event promises to gather Heads of Pharmacovigilance, Directors of Drug Safety, Medical Affairs Officers, Medical Safety Managers from regulatory authorities and leading pharmaceutical companies to brainstorm and share insights on: • Developing and implementing risk management and minimisation plans for improved drug safety • Preparing for audit and inspection: practical steps to get it right • Achieving compliance in various country regulations in Asia while meeting global safety requirements • Meeting the challenges of AE reporting for post-marketing surveillance studies • Establishing an early detection system for improved drug safety • Best practices in benefit-risk analysis to capture and characterise drug profiles Reserve your seat at the conference and the four workshops today. Equip yourself with knowledge and skills in pharmacovigilance strategic planning and daily operations. See you in Singapore this September! Yours sincerely, Yuyuan Chen Conference Producer Pharma IQ – A Division of IQPC Worldwide What makes this the must-attend event for the pharmaceutical industry • The ONLY event that focuses entirely on the pharmacovigilance landscape in Asia: your best opportunity to meet the region’s leading experts on PV to learn best industry practices on how they overcome their PV challenges • 1 full day dedicated for regulatory updates by Uppsala Monitoring Centre, European Commission, and regulatory authorities of China, India, Taiwan, South Korea, Vietnam and Brunei • 10 industry best practice case studies to empower you with proven successful tools: hear what your peers are doing to comply with regulatory requirements, improve risk management and prepare for audit and inspections • 4 workshops to maximise your opportunity out of office: learn insights on (1) preparing audits and inspection, (2) implementing risk management and minimization plans, (3) establishing effective early detection system and (4) achieving compliance with various country regulations in Asia • 1 regulator-led roundtable discussion: sit along with regulators and discuss the future of pharmacovigilance in various countries and how you can play a part in shaping this • Over 6 hours of networking opportunities plus a dedicated speed networking session for you to interact with regulators and senior pharmacovigilance professionals “The IQPC Pharmacovigilance conference in Singapore, which is becoming an annual event is, to my knowledge, the most comprehensive information exchange and discussion forum dedicated to pharmacovigilance held in Asia so far.” Head of Pharmacovigilance Asia-Pacific, Bayer Healthcare Global R&D Centre P.S. Take advantage of our early bird offer! Save up to SGD2,700 when you book and pay before 12 July 2012! Flip to the back page and register now! PHONE: (65) 6722 9388 • FAX: (65) 6720 3804 • EMAIL: enquiry@iqpc.com.sg • WEB: www.pharmacovigilanceasia.com
CONFERENCE DAY 1 Tuesday, 18 September 2012 08:30 Registration and Refreshments 09:00 Opening Address and Welcome from the Chairman 09:10 An Update from Uppsala Monitoring Centre (UMC): The Global WHO Pharmacovigilance Network As WHO’s collaborating centre for international drug monitoring, UMC is important in promoting pharmacovigilance. Its role includes screening and analysing international adverse reaction data, communicating up-to-date scientific information, and setting up and running national pharmacovigilance programmes. In this event, UMC will address: • In-depth understanding of WHO International Drug Monitoring Programme • Building a harmonised global pharmacovigilance network: benefits and challenges • Understanding the advantages of a single global database system for safety information and analysis • Highlighting efforts to be made in Asia to establish a harmonised PV network A senior representative from Uppsala Monitoring Centre will address this topic. Please refer to www.pharmacovigilanceasia.com for updates. 09:45 Updates on Safety Database Development at National ADR Centre in China: Key Benefits and Implications for ADR Reporting Order #81 of MOH, China - “Provisions for Adverse Drug Reaction Reporting and Monitoring” - was announced on May 4, 2011 and was effective since July 1, 2011. This new PV regulation places obligations on the SFDA and regional monitoring centres. In this topic, Dr. Wu will address: • What the new PV regulation is all about • Insight into China’s central and local level ADR reporting systems • Examining the challenges in setting up safety database and how these were overcome • Case study: how National ADR Centre developed and implemented technology support systems • Understanding the implications for ADR reporting Dr. Du Wenmin Executive Director Shanghai Centre for ADR Monitoring, SFDA 10:20 Speed Networking – Maximise your networking time efficiently! Meet regulators and pharmacovigilance officers in this session and get settled into comfortable and open discussions throughout the conference. 10:40 Morning Refreshments and Networking Break 11:00 Regulatory Updates for Pharmacovigilance in South Korea – Ensuring you comply with market requirements Under Pharmceutical Affairs Law amendment on June 7, 2011, Korean Drug Safety Management Centre and Committee of Review of Safety Information were founded. In addition, PV planning (REMS) was piloted since July 2011. This presentation will address: • Understanding the Pharmaceutical Affairs Act amendments in 2011: What it entails and the implications for pharmaceutical companies • Pharmacovigilance planning (REMS) draft guidance and enforcement step by step until mandatory in 2017: how you prepare for it • Complying with Korea’s clinical trials and postmarketing reporting requirements A senior representative from Korea FDA will address this topic. Please refer to www.pharmacovigilanceasia.com for updates. 11:35 Surmounting the Challenges in Developing an Effective Pharmacovigilance Programme in India In December 2011, the Indian Council of Medical Research (ICMR) announced to lay down new guidelines to compensate volunteers for injuries during clinical research programmes. Meanwhile, under PV Programme of India (PvPI), additional 60 ADR monitoring centres would be enrolled. This presentation will address: • The new ICMR guidelines’ impact on pharmaceutical industry – how to adjust to the new guidelines • Examining the major achievements of PvPI in the past year • Understanding the obstacles encountered when rolling out the PvPI programme and how these were overcome • Progress report – planning for next year’s activities: what you can look forward to • Lessons learned: how to build a nation-wide pharmacovigilance programme engaging all stakeholders Dr. Y K Gupta Coordinator, National Pharmacovigilance Programme, India, Professor and Head, Department of Pharmacology, All India Institute of Medical Sciences 12:10 Lunch and Networking Break 13:10 Updates from the European Commission: Implementing a New Pharmacovigilance System in Europe On 15 December 2010, the European Union enacted a new set of pharmacovigilance legislations that will take effect in July 2012. Under the new legislations, new PV system will be established to address new requirements on marketing authorisation holders, national competent authorities and the EMA, amongst others. This topic will address: • What is the new PV system all about • Strengthening and rationalising the existing safety monitoring system: what to be done PHONE: (65) 6722 9388 • FAX: (65) 6720 3804 • EMAIL: enquiry@iqpc.com.sg • WEB: www.pharmacovigilanceasia.com
Page 1: Book and pay before 12 JULY 2012 an
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