Medical Device and IVD Regulations in Asia-Pacific

Transcription

1 June 2013 Danubius Hotel Regents Park London UK Expert speaker faculty includes: Regulatory authority Saleh Al Tayyar, Vice Executive President for Medical Devices Sector, Saudi FDA & Chairperson, AHWP, Saudi Arabia Notified bodies Gert Bos, Head of Regulatory and Clinical Affairs, BSI, UK Mikako Kameya, Lead Auditor, SGS Japan Inc., Japan Regulatory Authority Liang Qian, Medical Device Regional Lead Asia Pacific, BSI Group, MinYong Choi, Technical Manager, Asia Pacific, Health Sciences, Underwriters Laboratories Inc, South Korea Georg Bauer, Manager Foreign Affairs, Medical Health Services, TÜV SÜD Product Service GmbH, Germany Eric C Leung, General Manager, Strategy and Business Development, Underwriters Laboratories Inc., Industry practitioners Jack Wong, Founder of Asia Regulatory Professional Association and Secretariat of Asia Harmonisation Working Party (AHWP), Singapore Gemma Ritchie, Divisional VP Regulatory and Clinical Affairs, Emerging & International Markets, Smith & Nephew, United Arab Emirates Toni Kennet Jörgensen, Head of Corporate Regulatory Affairs (SVP CRA), Institut Straumann, Switzerland Philippe Auclair, Regulatory Strategy & Advocacy, Abbott Quality & Regulatory EMEA, Abbott Laboratories, Belgium Pavel Hencl, Director CIS Region, Gambro, Germany Anthony Wilkinson, Medical Director, COOK Medical, Yvonne Middlefell, Director, Global Regulatory Affairs, LifeScan Scotland Ltd. (a Johnson & Johnson Company), UK Eric Verstegen, Director Corporate Regulatory Affairs, Institut Arkan Zwick, Regulatory Affairs Director, CROMA Pharma GmbH, Austria Susana De Azevedo Waesch, Head of Global Regulatory Affairs, Geistlich Pharma, Switzerland Tim Whitchurch, Staff Engineer, Safety Risk Management & Surveillance, Ortho Clinical Diagnostics (Johnson & Johnson), UK Marta Carnielli, Safety Risk Management & Surveillance Manager, Ortho Clinical Diagnostics European Support Center, France Alexandra Baer, Regulatory Affairs Manager, Croma Pharma GmbH, Austria Zhenrong Yu, Manager, Regulatory Affairs, Advanced Bionics AG, Switzerland Anthony Wilkinson, Medical Director, COOK Medical, Alan A. Chalmers, Director, Pharma International, Switzerland Celine Malo, International Regulatory Affairs Consultant, Meditec Consulting GmbH, Switzerland To Register: Please quote CQ7105 Please Tel: +44 (0) Fax: +44 (0) New for 2013: 3 Ensure successful market authorisation and renewal in China: Case studies from CROMA PHARMA and Advanced Bionics 3 Share experiences and gain practical advice for type testing devices in 3 Effectively prepare for and streamline external audits from Competent Authorities 3 Discover how Geistlich Pharma successfully achieved market approval in Japan 3 Hear how the regulatory system in Australia and New Zealand is changing and what is currently expected for market authorisation 3 Gain detailed insight into the clinical trial and data requirements in 3 Examine IVD registration requirements and expectations in Asia Pacific and discover how LifeScan Scotland successfully overcame them 3 Master current regulation and prepare for future regulatory change in Taiwan 3 Keep up to date with the labelling and packaging requirements in, including new Chinese labelling regulation 3 Discover how software is being regulated as a medical device across the region Conference highlights: 3 Gain the latest updates on regulatory harmonisation, including progress at AHWP and the IMDRF 3 Understand regulatory requirements and upcoming change in key markets: China, Japan, Korea and India 3 Ensure you are compliant post market: Essential updates on post market surveillance and vigilance expectations 3 Discover requirements for drug device combination products across the Asia Pacific region 3 Find out where regulation is changing in Taiwan and how industry can prepare 3 Evaluate progress on the ASEAN Medical Device Directive Don t miss these interactive learning and networking opportunities: Pre-conference evening seminar X: Monday 10 June 2013 Ensuring regulatory success in key Latin American markets Led by: Susana de Azevedo Wäsch, Head of Global Regulatory Affairs, Geistlich Pharma AG, Switzerland Evening seminar Y: Tuesday 11 June 2013 Understanding current and emerging medical device and IVD regulations in Saudi Arabia and the Gulf Cooperation Council (GCC) region Led by: Claudia Ising, Head of Regulatory Affairs Department, Lohmann & Rauscher GmbH & Co KG, Germany Evening Seminar Z: Wednesday 12 June 2013 Reviewing medical device and IVD regulations in Russia and the Commonwealth of Independent States (CIS) Led by: Pavel Hencl, Director CIS Region, Gambro, Germany Web: registrations@informa-ls.com The Asia Pacific medical device market will grow at more than 10% over the next 3 years compared to a global sector growth of 6 % Informa Life Sciences 7th Annual Medical Device and IVD Regulations in The latest regulatory developments and practical industry experiences in order to achieve faster market access across the region Interactive session with networking dinner New for 2013 New for 2013

2 Very interesting content, knowledgeable presenters and attendees, great opportunity for networking Project Manager, Boston Scientific (Delegate 2012) Conference Day 1: Tuesday 11 June :30 Registration opens 09:00 Opening remarks from the Chair Secretariat of Asia Harmonisation Working Party (AHWP), Singapore Regulatory harmonisation: Progress at AHWP and IMDRF 09:10 Regulatory harmonisation in Asia: Providing an essential update on developments and progress of the Asian Harmonisation Working Party (AHWP) Outlining the recent, current and future objectives of the AHWP Providing a status update on current projects, their developments and the impact on industry COMPETENT AUTHORITY How can industry prepare for future regulatory harmonisation in? Saleh Al Tayyar, Vice Executive President for Medical Devices Sector, Saudi FDA & Chairperson, AHWP, Saudi Arabia 09:50 Exploring the work of the International Medical Device Regulators Forum (IMDRF) and impact on the region Discussing the evolution from the Global Harmonisation Task Force (GHTF) to the IMDRF: What has changed and why? Assessing current and planned projects of the IMDRF What are the priorities of IMDRF in and what will the impact on regulations be? Addressing the implications for industry and providing essential advice for readiness Gert Bos, Head of Regulatory and Clinical Affairs, BSI, UK China 10:30 Understanding the regulatory requirements and upcoming changes to the Medical Device Regulation from China s Food and Drug Administration (SFDA) Understanding the organisation of the government body, system and approving Competent Authority (SFDA) Outlining registration and submission requirements for medical devices in China Outlining timelines, phases and milestones for approval Highlighting where to find resources for regulations, updates and suitable contacts contact points from the Chinese FDA (SFDA) What can be expected from the revised Medical Device Directive in 2013? Secretariat of Asia Harmonisation Working Party (AHWP), Singapore 11:10 Morning coffee and networking 11:40 Successfully navigating the Chinese regulatory system, requirements and approval process: Case study Essential considerations for preparing the registration process Practical experience of timelines and milestones for a class 3 implantable medical device approval Essential considerations for clinical trials and dealing with testing centres Addressing questions received from the SFDA and supplementary information requested Recommendations for establishing open communication with the SFDA and ensuring product understanding by assessors Coping with the evolving regulatory expectations and pop-up regulation for medical devices How to integrate differing regulatory requirements in EU technical dossier and Notified Body considerations Practical experience of timelines and milestones for a class 3 medical device approval and renewal Arkan Zwick, Regulatory Affairs Director, CROMA PHARMA GmbH, Austria Alexandra Baer, PhD, Regulatory Affairs Manager Registrations in Asia Pacific, CROMA PHARMA GmbH, Austria 12:20 Preparing for and successfully achieving renewal in China: Case study Outlining the process for renewal in China Essential considerations for preparing the timing of re-submissions Examining the documentation, supporting data and supplementary expectations for re-submission Evaluating the differences between market authorisation registrations and resubmissions in China Assessing what can be negotiated or omitted for the renewal Establishing best practices: What worked, what didn t and what would be done differently Zhenrong Yu, Manager, Regulatory Affairs, Advanced Bionics AG, Switzerland 13:00 Lunch and networking Type testing 14:00 Interactive discussion: Practical considerations for type testing across Where is type testing required and why? What countries are likely to start type testing in the future and is there potential for harmonisation? Special considerations for type testing in China: What you need to know Sharing practical advice for choosing testing centres and ensuring fast and successful testing What are the essential considerations for type testing of highly advanced medical devices? Is there a need for greater transparency surrounding type testing? Facilitated by: Jack Wong, Founder of Asia Regulatory Professional Association and Secretariat of Asia Harmonisation Working Party (AHWP), Singapore Panel members include: Arkan Zwick, Regulatory Affairs Director, CROMA PHARMA GmbH, Austria Alexandra Baer, PhD, Regulatory Affairs Manager Registrations in Asia Pacific, CROMA PHARMA GmbH, Austria Successful audits 14:40 Practical experiences of external audits from Competent Authorities (CA) Preparing and hosting external audits from CA or their 3rd parties Reviewing the different audit approaches of CA or their 3rd parties How can industry best prepare and streamline the number of audits Assessing who currently requires audits and where new audit requirements may come from Tim Whitchurch, Staff Engineer, Safety Risk Management & Surveillance, Ortho Clinical Diagnostics (Johnson & Johnson), UK 15:20 Afternoon tea and networking Post market surveillance and vigilance 15:50 Providing a regional overview of the post market surveillance (PMS) and vigilance requirements across Outlining which countries have PMS and vigilance requirements in Comparing EU and ASPAC vigilance requirements Highlighting timelines, forms and routes for vigilance reporting across Discussing how individual country requirements can be incorporated into regional or global PMS and vigilance systems/processes Marta Carnielli, Safety Risk Management & Surveillance Manager, Ortho Clinical Diagnostics European Support Center, France Drug Device Combination Products (DDCPs) 16:30 Achieving regulatory success for Drug Device Combination Products (DDCPs) across Asia Pacific Understanding the regulatory and classification requirements for DDCPs across key markets Outlining the similarities and differences to the regulation of DDCPs in Europe Essential considerations for tackling the differences in regulation for DDCPs across the region Overcoming common challenges in DDCP applications, including expectations on: Chemical characterisation, standards, raw materials and formulations What regulatory developments can be expected for DDCPs in the region? Anthony Wilkinson, Medical Director, COOK Medical, 17:10 Closing remarks from the Chairperson 17:15 End of conference day 1 17:30 Registration for evening seminar begins

3 I am very satisfied with the program and especially the high skilled presenters. I would very much like to attend another course Global Regulatory Affairs Manager, Ferring Pharmaceuticals (Delegate 2012) Conference Day 2: Wednesday 12 June :00 Opening remarks from the Chair Dr Philippe Auclair, Regulatory Strategy & Advocacy, Abbott Quality & Regulatory EMEA, Abbott Laboratories, Belgium Japan 09:10 Examining the regulatory system in Japan: Current status and upcoming changes Outlining the Ministry of Health, Labour and Welfare (MHLW) and Pharmaceuticals and Medical Devices Agency (PMDA) expectations for regulatory approval in Japan Addressing common timelines and costs for registration Highlighting the new classification system in Japan: What is the impact on Industry? Assessing import requirements for Japan, including expectations on quality control records Discussing Japanese biocompatibility requirements and differences to EU/US accepted tests Addressing regulatory harmonisation efforts in Japan New changes to Japanese regulations: What can be expected in 2014/15 and how can industry prepare? Mikako Kameya, Lead Auditor, SGS Japan Inc., Japan 09:50 Practical experience from gaining regulatory approval in Japan: Case study Discussing the impact of recent PMDA reform and the reclassification of devices Lessons learned from identifying and establishing a legal partner/ representative in Japan Discussing what requirements or studies can be negotiated, bridged or waived for Japan Preparing effectively for registration in Japan: How to get the most from pre-submission consultations, product definitions and preliminary planning Outlining the time, costs and common obstacles to approval Highlighting failures and what would be done differently in retrospect Susana de Azevedo Wäsch, Head of Global Regulatory Affairs, Geistlich Pharma AG, Switzerland 10:30 Morning coffee and networking India 11:00 Examining the current regulatory environment and how this will change under the new medical device regulation in India Outlining how medical devices are currently regulated in India Evaluating the current status of the new guidance and how medical device regulation will change under the new system Highlighting current type testing requirements and the potential for future change Assessing the current list of regulated devices and how/when this will increase Discussing advantages of voluntary registration in India Essential advice for preparing a regulatory strategy for India given the impending change in regulation Dr Philippe Auclair, Regulatory Strategy & Advocacy, Abbott Quality & Regulatory EMEA, Abbott Laboratories, Belgium 11:40 Preparing for regulatory change in Assessing what the current regulatory system in requires for medical devices What regulatory change is planned, what can be expected and when? Discussing the potential for a transition period for registrations in Addressing whether voluntary registration status now will be of benefit for mandatory registrations later Essential advice for preparing regulatory strategies for with regulatory change imminent Secretariat of Asia Harmonisation Working Party (AHWP), Singapore 12:20 Lunch and networking Australia and New Zealand 13:30 Interactive discussion: Understanding and sharing experience of the regulatory systems in Australia and New Zealand This session will open with a presentation from the chairman before opening up discussion with the audience and other members of the speaker faculty. Points to be addressed include: Providing an overview of Australia s Therapeutic Goods Administration (TGA) and their registration requirements for medical devices Understanding the requirements of New Zealand s Medicines and Medical Device Safety Authority (MedSafe) for medical device registration Discussing the termination mutual recognition procedure for high risk medical devices by the TGA for EU certified products and assessing whether confidence building see this decision reversed Addressing recent progress and what can be expected from the new Australia New Zealand Therapeutic Products Agency (ANZTPA) What are the likely implications of ANZTPA for industry processes and strategies? Chair: Georg Bauer, Manager Foreign Affairs, Medical Health Services, TÜV SÜD Product Service GmbH, Germany Clinical trial and data requirements 14:10 Evaluating clinical trial and data requirements for countries of the region Examining where clinical evidence is required across and what this involves Addressing where local studies or data is mandatory Assessing where studies can be bridged from already registered devices Highlighting where changes to clinical trial and data requirements may occur Learning from past experience: Practical advice for industry Gemma Ritchie, Divisional VP Regulatory and Clinical Affairs, Emerging & International Markets, Smith & Nephew, United Arab Emirates 14:50 Afternoon tea and networking Regulation of in vitro diagnostics (IVDs) 15:20 Reviewing the IVD registration requirements and expectations across the region Outlining the classification systems for IVDs across Asia Pacific Evaluating where there are differences for IVD registrations and how these should be met Assessing where changes are planned for IVD registration across Addressing which countries can be grouped for similar IVD requirements in the region Celine Malo, International Regulatory Affairs Consultant, Meditec Consulting GmbH, Switzerland 16:00 Providing practical experience of successfully registering IVDs across : Case studies Highlighting common challenges for classifying IVDs across Essential considerations for constructing a regulatory strategy for your IVD Practical advice for overcoming the differences in regulatory requirements for IVDs across the region Discussing decision letters received and how have these were responded to Outlining unexpected challenges and how these were overcome Essential hints and tips when registering IVDs in Asia Yvonne Middlefell, Director, Global Regulatory Affairs, LifeScan Scotland Ltd. (a Johnson & Johnson Company), UK 16:40 Closing remarks from the Chairperson 16:45 End of conference day 2 17:30 Registration for evening seminar Media Partners:

4 It was a one stop shop opportunity to learn about regulatory requirements of Country Business Manager/Senior Director, SGS (Speaker 2012) Conference Day 3: Thursday 13 June :00 Opening remarks from the Chairperson Korea 09:10 Understanding and preparing for regulatory changes in Korea An overview of the regulatory requirements for Medical Devices in Korea: What is changing and what remains? Assessing the new classification system for medical devices and IVDs, including the impact on dossier requirements Audits in Korea: Expectations for manufacturers, importers and the potential for auditing by third parties Essential considerations for establishing effective dialogue with the Korean FDA (KFDA) Discussing the implementation of new regulation in 2013 and assessing what is still to change MinYong Choi, Technical Manager, Asia Pacific, Health Sciences, Underwriters Laboratories Inc, South Korea 09:50 Interactive session: Achieving successful product registration in Korea Highlighting the impact of the new classification system in Korea Discussing what requirements/studies can be waived, negotiated or bridged (e.g. Biocompatability) for Korea Essential considerations for communicating effectively with the KFDA; using local partners Practical experience of dealing with audits: Outlining differences to other audit expectations, preventing the disclosure of confidential information and overcoming the number of inspection reports Assessing how legal and commercial entities in Korea were eparated and the practical implications Addressing timelines, costs and unexpected challenges in the registration process Session chairs: MinYong Choi, Technical Manager, Asia Pacific, Health Sciences, Underwriters Laboratories Inc, South Korea Alan A. Chalmers, Director, Pharma international, Switzerland 10:30 Morning coffee and networking Taiwan 11:00 Providing an essential overview of current regulation and future change in Taiwan Outlining the organisation of government body, regulatory system and approving Competent Authority for medical devices in Taiwan Addressing recent change at the FDA of Taiwan and the implication for regulations Outlining the regulatory requirements for approval in Taiwan Essential advice for simplifying regulatory approval in Taiwan Addressing plans for updates to Taiwanese medical device regulation and when these can be expected Liang Qian, Medical Device Regional Lead Asia Pacific, BSI Group, Regulation in the ASEAN region 11:40 Evaluating progress on harmonisation in the ASEAN region and the development of the ASEAN Medical Device Directive Assessing the objectives and recent progress concerning the ASEAN Medical Device Directive Outlining the timelines for the implementation of the ASEAN Medical Device Directive Discussing how harmonised ASEAN countries will become and what this will mean for industry Anticipating what the requirements will look like, including: technical documentation, language, good distribution practice Evaluating the current use of the Common Submission Dossier Template (CSDT) across the ASEAN region Addressing where differences in medical device regulation will remain and how industry can overcome these differences Alan A. Chalmers, Director, Pharma international, Switzerland 12:20 Lunch and networking 13:30 Essential update on Thailand s regulatory system for medical devices Examining the organisation of the government body, system and approving Competent Authority for medical devices and IVDs Highlighting submission and registration requirements for Thailand Addressing biocompatibility study requirements in Thailand Discussing timelines for approval and anticipated costs of registration in Thailand Essential considerations for language requirements when registering in Thailand 14:10 Addressing regulatory requirements in other key ASEAN countries Outlining the current status of medical device regulation in the wider ASEAN region, including the Philippines and Indonesia Comparing and contrasting registration requirements in the Philippines and Indonesia Addressing where progress has been made on regulatory harmonisation in line with the ASEAN Medical Device Directive Assessing where and when regulatory change can be expected in the ASEAN region Understanding how to overcome common challenges for medical device registration in the wider ASEAN region 14:50 Afternoon tea and networking Labelling and packaging in 15:20 Providing a concise overview of labelling and packaging requirements and challenges in Comparing and contrasting the labelling requirements of countries within Assessing the differing requirements on Instructions For Use (IFU) across the region, the impact on industry and strategies to tackle IFUs Addressing the new labelling requirements in China: How to prepare and overcome the latest changes Discussing the future application of the Unique Device Identifier (UDI) and making comparisons to progress in the EU and US Outlining language requirements across the regions Consideration for eifu, can this be implemented world wide and what are the expectation in? Dr Toni Kennet Jörgensen, Head of Corporate Regulatory Affairs (SVP CRA), Institut Straumann, Switzerland Regulating software as a Medical Device 16:00 Software as a medical device: Reviewing the current status of regulation across Evaluating the current requirements for software as a medical device across Discussing whether current regulators are ready for the assessment of software as a medical device Questioning whether there is a need for a change to current regulatory systems to accommodate software assessment Outlining specific considerations for regulation of apps/software in China Highlighting the critical considerations for industry and preparing for potential change Eric C Leung, General Manager, Strategy and Business Development, Underwriters Laboratories Inc., 16:40 Closing remarks from the Chairperson 16:45 End of conference Don t miss out on 17 industry practitioners, 6 notified bodies and 1 competent authority 10+ hours of formal and informal networking opportunities 6 industry case studies and 7 interactive sessions Europe s premier conference dedicated to Medical device and IVD regulation in the Asia Pacific region

5 Looking for more information on regulations in other emerging market Excellent content, excellent speakers. Heartily recommended Regulatory Affairs Officer, IDS Ltd (Delegate 2012) Pre-Conference Evening Seminar & Networking Dinner X: Monday 10 June 2013 Ensuring regulatory success in key Latin American markets regions? Latin America represents a key developing region for IVD and medical device manufacturers looking to increase revenues given stabilising traditional markets. By attending this evening session, delegates can gain an in-depth understanding of the current regulatory systems, requirements and future developments across four key Latin American markets. The seminar will focus primarily on Brazil, Mexico, Columbia and Argentina. Topics to be addressed include: Understanding the regulatory systems and Competent Authorities Classification systems Product registration requirements Timelines and costs for approval Identifying partners in the region Post market surveillance and vigilance Price monitoring and control Mutual recognition in the region Harmonisation efforts Planned and potential regulatory change Led by: Susana de Azevedo Wäsch, Head of Global Regulatory Affairs, Geistlich Pharma AG, Switzerland Evening Seminar & Networking Dinner Y: Tuesday 11 June 2013 Understanding current and emerging medical device and IVD regulations in Saudi Arabia and the Gulf Cooperation Council (GCC) region The evening session will provide an essential update on current and developing regulatory requirements for the countries of the region. Additionally this will provide a unique opportunity to learn from and network with industry colleagues working in the area. The seminar will focus on Saudi Arabia, UAE and overview key developments in the region. Topics include: Classification of Medical Devices and IVDs Registration requirements and dossiers Approval timelines and phases Recent changes in registrations for the UAE Common areas of guidance misinterpretation Distributor and local representative requirements Developments from work with the Asian Harmonisation Working Party Enforcement of regulation in Saudi Arabia: When and how? Post approval responsibilities and expectations Recommendations for streamlining registrations What regulatory change is planned for the region? Led by: Claudia Ising, Head of Regulatory Affairs Department, Lohmann & Rauscher GmbH & Co KG, Germany Evening Seminar & Networking Dinner Z: Wednesday 12 June 2013 Reviewing medical device and IVD Regulations in Russia and the Commonwealth of Independent States (CIS) Russia and the CIS are becoming increasingly important to global strategies for Medical Device and IVD manufacturers. Delegates attending this seminar can expect to take away essential information regarding the current regulatory organisation, requirements and expectations for Russia in addition to an overview of the CIS markets. Topics to be addressed include: Understanding the regulatory system and governing bodies in Russia Outlining the regulatory systems of the CIS countries Registration requirements and expectations Recent changes and current developments in Medical Device and IVD regulations Common challenges and how to overcome them Labelling requirements Language requirements Mutual recognition opportunities in Russia and the CIS Success and failure stories Defining the fastest routes to market Compliance between manufactures and medical professionals 3 Interactive learning and networking sessions Use this informal and interactive session to pose key questions to the expert seminar leader in addition to other seminar attendees before exchanging experiences over dinner. Led by: Dr Pavel Hencl, Director CIS Region, Gambro, Germany About PTI PTI Pharmaceutical Training International PTI is a global pharmaceutical training company with over 60 interactive courses focusing on Regulatory Affairs, R&D, Clinical Development, Manufacturing,Veterinary Medicine, Medical Devices, Biopharmaceuticals and Agrochemical best practices. Whether you are new to the industry or firmly established and looking for training to take you to the next level, you will receive practical information and comprehensive advice to meet the demands of a challenging career in the Life Sciences industry. Our courses can also be delivered on-site, specifically tailored to place emphasis on your company s own particular business objectives. For more information on PTI, please contact: Masaud Mirza, Tel: +44 (20) masaud.mirza@pti-global.co.uk Feedback from the Chairperson: Informa s Medical Device and IVD Regulations in conference is of importance to me because it provides the best opportunity to meet specialists and key stakeholders in the area and provides excellent networking opportunities. Most of all, it provides the opportunity to anticipate changes in this dynamic environment, before the changes become an issue. I would attend the event even if I had to pay for it myself Eric Verstegen, Director, Corporate Regulatory Affairs, Institut