Accelerating Drug & Clinical Trial Approvals in China & East Asia

Transcription

1 25 28 March 2014 The Westin Beijing Chaoyang, Accelerating Drug & Clinical Trial Approvals in & East Asia What s New in 2014? Key Regulatory Update from the National Institute for Food & Drug Control, MORE Drug Regulations & Case Studies Electronic Regulatory Affairs Learn from Industry Best Practices Pharmaceutical Marketing Regulations Pediatric Investigational Plans (PIPs) Interactive & Open Discussion Session on Quality by Design (QbD) Discover Bridging Studies and Waiver Opportunities Drug-Device Combination Products 2014 Regulatory Experts Include: Prof. Ning Bao Ming Deputy Director, Division of Chemical Drugs/GMP Inspector, National Institute for Food and Drug Control, Agency of the CFDA, Annette Chiu Regulatory & Medical Affairs Director, GlaxoSmithKline, Chairperson of the Regulatory Affairs Committee, Hong Kong Association of the Pharmaceutical Industry, Hong Kong Stewart Geary Vice President/Deputy Director, Corporate Regulatory Compliance & QA, Eisai Japan, Director, The Japanese Association of Pharmaceutical Medication (JAPhMed), Japan Dr Wu Ke President, BravoBio, May Wei Global Regulatory Strategist, Bayer Healthcare, PLUS! Informative Workshops on: PRE-CONFERENCE WORKSHOPS 25 MARCH 2014 A Preparing and Submitting Dossiers for Generic Drug Approval B Gaining Global Approvals of Biosimilars POST-CONFERENCE WORKSHOPS 28 MARCH 2014 C D Regulatory Strategies for Emerging Market Access Pediatric Drug Development Produced by: Supporting Organisation: Media Partners: Life Sciences International Marketing Partner: REGISTER NOW! Customer Service Hotline: /

2 CONFERENCE DAY ONE 26 March 2014 Wednesday 0815 Registration Opens & Morning Coffee 0850 Welcome from IBC Asia & Speed Networking 0900 Chairperson s Opening Remarks Prof. Jack Wong, Director, Regulatory Affairs, Terumo BCT, Secretariat in Asian Harmonization Working Party (AHWP) and Founder of Asia Regulatory Professional Association (ARPA), Singapore & East Asian Regulatory Updates 0910 Gaining Clarity on s Pharmaceutical Regulations Introduction to the Chinese drug registration and approval process Implications of the recent Chinese Food and Drug Administration re-structuring Challenges faced when seeking drug approval in and how to overcome them Opportunities and future trends for drug approval in Prof. Ning Bao Ming, Deputy Director, Division of Chemical Drugs/GMP Inspector, National Institutes for Food and Drug Control, Agency of the CFDA, 0950 In-depth Understanding of Hong Kong s Regulatory Approval Process Understand the registration system in Hong Kong Opportunities to accelerate the registration procedure Key industry insights on how to deal with the various regulatory barriers Vital advice on a successful application in Hong Kong Annette Chiu, Regulatory & Medical Affairs Director, GlaxoSmithKline, Chairperson of the Regulatory Affairs Committee, Hong Kong Association of the Pharmaceutical Industry, Hong Kong 1030 Morning Refreshments & Networking Break 1100 Japan s Regulatory Updates: Introduction to Japan s New Risk Management Plan Overview of Japan s Drug Regulations, Approval Processes and Timelines Introduction and highlights of the newly implemented Risk Management Plan What are the implications of this new Risk Management Plan? Critically compare the Risk Management Plans between Japan and EU/US and highlight the differences in risks Stewart Geary, Vice President/Deputy Director, Corporate Regulatory Compliance & QA, Eisai, Japan, Director, The Japanese Association of Pharmaceutical Medication (JAPhMed), Japan 1140 Achieving a One-time Regulatory Approval in Taiwan Structural overview and latest initiatives from Taiwan s FDA Critical insights into the drug registration and approval process in Taiwan Challenges faced when seeking approvals and how to overcome them Trends and tips on gaining entry into Taiwan s Pharmaceutical market Amber Wang, Regulatory Affairs Manager, GlaxoSmithKline, Taiwan 1220 Navigating Korea s Regulatory Landscape Updates and key insights on Korea s drug registration and approval process Common challenges and what can be done to address it Impacts on industries and what can be done to mitigate these impacts Industry advice on getting a successful application in Korea Dr Jisu Kim, Director General, Korea Health Industry Development Institute (KHIDI), 1300 Networking Lunch Accelerating Drug & Clinical Trial Timelines & Approval Processes 1430 Strategies for Dealing with Long Approval Timelines Recognize the various regulatory barriers in Asia and how to overcome them What are the options to fast track the drug approval process Strategies for a successful and quick drug approval process Dr Yamin Wang, Head, Global Regulatory Affairs, Asia Pacific, Bayer Healthcare Pharmaceuticals, Singapore 1510 Efficiently Conducting Clinical Trials in : Opportunities for Bridging Studies and Waivers Overview of the different regulatory processes, requirements and approval timelines for regional and global trials Challenges faced in and how to address them Regulatory strategy for conducting bridging studies in Advice in getting waivers in Asia Opportunities for Multi- Regional Clinical Trials (MRCTs) in East Asia Industry tips in choosing the right location for clinical trials Case studies on previous bridging studies Shell Li, Head of Clinical Research, Boehringer-Ingelheim, 1600 Afternoon Refreshments & Networking Break Drug-Device Combination Products Regulatory Environment 1630 Regulatory Requirements for Drug-Device Combination Products in Main differences between the registration process of medical device and drugs What are the main guidelines that all Regulatory Affairs or Medical Device professionals should know about Overview of the development trend of combination products in Asia Regulatory Strategies to get fast approvals Tips to gain access of the drug-device combination products market in Asia Prof. Jack Wong, Director, Regulatory Affairs, Terumo BCT, Secretariat in Asian Harmonization Working Party (AHWP) and Founder of Asia Regulatory Professional Association (ARPA), Singapore E-Regulatory Affairs 1705 Industry Experiences in using the Electronic Common Technical Document (e-ctd) Benefits and difficulties in using the e-ctd Industry tips on overcoming the challenges faced in e-ctd Crucial advice in transitioning to paperless submissions Future of the e-ctd Nitin Gaikwad, Deputy General Manager, Lupin Limited, India 1740 Chairman s Closing Remarks & End of Conference Day One CHINA FOCUS

3 CONFERENCE DAY TWO 27 March 2014 Thursday 0900 Chairperson s Remarks Dr Lin Hong, Associate Director, Regulatory Affairs, Asia Pacific Russia CIS (APAC) Established Pharmaceuticals, Abbott, USA Clarifying Product Guidelines 0905 Interpreting Fixed-Dose Combination Products (FDC) Guidelines Understanding the EU, US, and Health Authorities regulations Difficulties faced when seeking approvals and methods to overcome them Regulatory strategies in developing and successfully launching FDC products into the market May Wei, Global Regulatory Strategist, Bayer Healthcare, 0940 Success Strategies for OTC Drug Approval in Asia and How it Compares with the EU/US Overview of the OTC drug industry and approval process in Asia What are the options to fast track your OTC in the Asean region How does the OTC drug industry in Asia compare to EU/US Key differences in regulations between Asia and EU/US Ng Cheng Tiang, Director, Regulatory, Teva Pharmaceuticals, Singapore 1015 Morning Refreshments & Networking Break 1045 Making Sense of the Orphan Drug Regulatory Landscape in Overview of the current processes/regulations in the orphan drug registration process in Detailed comparison of the different orphan drug regulations in Asia Industry advice on tackling the difficulties in getting the orphan drug approved into the market Dr John Z. Gong, Vice President of Drug Development and Regulatory Affairs, Beigene, PANEL DISCUSSION CHINA FOCUS CHINA FOCUS 1120 Achieving Vaccines Approvals in Understanding key vaccines regulations in Overview of vaccines clinical trials regulations Regulatory approvals of vaccines in times of a pandemic Tips to efficiently get vaccines into the market Barriers for both authorities and industry to overcome Dr Wu Ke, President, BravoBio, 1200 Networking Lunch 1320 The Hurdles to Biosimilars in Asia Challenges faced by industry and authority and how these can be addressed Operational, regulatory and commercial concerns Future trends of the biosimilars industry Moderator: Dr John Z. Gong, Vice President of Drug Development and Regulatory Affairs, Beigene, Panelists: Dr Bobby George, Assistant Vice President/Head, Regulatory Affairs, Reliance Biopharmaceuticals Pvt Ltd,India Amber Wang, Regulatory Affairs Manager, GlaxoSmithKline, Taiwan Penny Field, Director and Principal Consultant, Bioregulatory Consulting, Australia Dossier Submission 1400 Dossier Submission Best Practices Key elements to a good dossier Differences between the dossier requirements of biological and chemicals Industry best practices on managing dossier submissions Learn what are other companies are doing in their dossier submission practices Dr Bobby George, Assistant Vice President/Head, Regulatory Affairs, Reliance Biopharmaceuticals Pvt Ltd, India Regulatory Compliance & Pharmaceutical Safety 1445 Methods of Pharmaceutical Marketing while Complying with the Diverse Regulations in Asia Trends in the regulatory landscape in Asia as well as globally What are the effects of regulations on marketing and advertising activities Discuss methods and share tips on how companies are complying with the regulations Key insights on entering the Asia pharmaceutical market Pharmaceutical marketing strategies : Pricing, reimbursement Strategies for product launches Sabrina Chan, Executive Director, Hong Kong Association of the Pharmaceutical Industry, Hong Kong 1520 Afternoon Refreshments & Networking Break 1550 A Risk Management Plan to Tackle Ethnicity Differences Selecting a regulatory strategy to minimize ethnic risks What action plan can be implemented to address such risk concerns in Asia Addressing the high cost challenges for post-marketing surveillance (PMS) How can Asian collaboration minimize such risks Vera Liang, Global Safety Risk Lead and Director, Safety Surveillance and Risk Management, Pfizer () R&D, 1625 CMC Regulatory Affairs and Expectations for Module 3 Post approval variations Stability Studies Analytical Validation Quality by Design: An Open Discussion Dr Lin Hong, Associate Director, Regulatory Affairs, Asia Pacific Russia CIS (APAC) Established Pharmaceuticals, Abbott, USA OPEN DISCUSSION International Regulatory Updates 1700 Current EMA Priorities and Perspectives Overview of the EU regulations and registration procedures Current priorities of the EMA What are the future initiatives of the EMA Pediatric Investigational Plans (PIPs) in the EU Prof. Andrea Laslop, Head of Scientific Office, Austrian Agency for Health and Food Safety (AGES) PharmMed, Austria and Austrian member at CHMP (Committee for Human Medicinal Products) at EMA (European Medicines Agency), Austria 1740 Chairperson s Closing Remarks End of the

4 WORKSHOPS PRE-CONFERENCE WORKSHOP 25 March 2014, Tuesday ( ) A Preparing and Submitting Dossiers for Generic Drug Approval This workshop is a practical and interactive session and guide for dossier preparation to achieve successful registrations. By attending the session participants will better understand the intricacies of dossiers requirements and benefit from an industry perspective to prepare and submit dossiers for registration of generic pharmaceutical products with focus on Chinese agency specific requirements. In addition, this workshop would be able to give participants additional benefit on the EU dossier submission requirements for a wider view on what is required in a mature regulated market. Topics to be discussed include: Dossier write-up for ICH CTD Different registration procedures in Europe i.e. DCP, MRP, Nationals and approval timelines Adapting an EU-CTD dossier for Chinese agency submission & registration Key inputs/critical success factors for dossier content and preparing an ectd submission Current guidelines under discussion and variation submissions for dossier life cycle management Timelines, language and document requirements for submissions Nitin Gaikwad, Deputy General Manager, Lupin Limited Nitin graduated with an MSc in Biochemistry from the University of Pune and he has over 20 years of regulatory affairs with Lupin Limited. Dealing with ectd submissions on a daily basis, he is very experienced in the field on ectd dossier submissions and is familiar with both Asian and EU regulations and dossier submission procedures. He also holds memberships in the Parenteral Drug Association, USA and the Indian Pharmaceutical Association. POST-CONFERENCE WORKSHOP 28 March 2014, Friday ( ) C Regulatory Strategies for Emerging Market Access By attending this workshop, participants will gain an understanding of the regulatory barriers and how they can effectively plan their entry into emerging markets successfully. Practical industry experience will be shared throughout the workshop and also a special case study on India, one of the world s largest emerging markets. Potentials and challenges of emerging markets Regulatory barriers when attempting to access emerging markets Finding a suitable regulatory partner in an emerging market Crafting the right development plan to ensure your success Comparison of regulatory strategies between developed (US and EU) and emerging Asian markets Regulatory strategies for accessing an emerging market, Do s and Don ts Dr. Bobby George, Vice President and Head of Regulatory Affairs, Reliance Life Sciences, India. Dr. Bobby George is Vice President and Head of Regulatory Affairs at Reliance Life Sciences, Mumbai, India and has over 16 years of industrial experience. At Reliance, he has been for over 11 years and is overall responsible for regulatory services across all their divisions (Pharmaceuticals, Biosimilars, Plasma proteins, Clinical research, Laboratory animal research, Regenerative Medicine and Cord blood services) both in domestic and export markets (around 40 countries). He has to his credit, 26 publications in both national and international peer reviewed journals. He has authored 3 book chapters and is on the editorial board as a reviewer for two peer reviewed journals. He has been the recipient of National awards The C.L. Malhotra award and the IDMA awards for the best research papers. He is also on the university panel of experts for review of Masters in Pharmacy and Ph. D thesis. PRE-CONFERENCE WORKSHOP 25 March 2014, Tuesday ( ) B Gaining Global Approvals of Biosimilars This interactive workshop with hypothetical case studies will give participants the opportunity to discuss the various technical and development challenges for Biosimilars, including biosimilar monoclonal antibodies. By attending this workshop, participants will go home with a sound knowledge on how to globalize their biosimilar into the key markets in the world as well as learning how to deal with the various technical challenges in the development of biosimilars. Biosimilars registration in the EU, US, Australia and Asia Development challenges for Biosimilars Selecting the appropriate reference product and requirements and challenges for establishing similarity with the reference product Penny Field, Director and Principal Consultant, Bioregulatory Consulting Penny Field is the Principal Consultant of Bioregulatory Consulting. Penny has worked in the pharmaceutical industry for 22 years; the past 20 years have been focused on the development and registration of medicinal products. Penny has consulted and prepared Investigational New Drug (IND), Clinical Trial Exemption (CTX) and Marketing Applications for New Chemical Entities (NCE), generics, monoclonal antibodies, immunotherapeutics, recombinant proteins, gene therapies and biosimilars. Penny has undergraduate qualifications in Biology with Honors in Biotechnology from Murdoch University and a Masters in Medical Science in Drug Development from the University of New South Wales (UNSW). Penny is the Course Coordinator for Research and Development in the Pharmaceutical Industry and Lecturer in the Postgraduate Program in Pharmaceutical Medicine and Drug Development (UNSW). She is also a Guest Lecturer in the RMIT Undergraduate Program in Pharmaceutical Sciences. POST-CONFERENCE WORKSHOP 28 March 2014, Friday ( ) D Pediatric Drug Development This workshop aims to give a comprehensive introduction on background and operational details of the EU Pediatric Investigation Plan (PIP) and its predeceasing US legislation. The workshop will give attendees an in-depth understanding of the clinical background to additional pediatric requirements in drug development, an introduction into pediatric clinical pharmacology, the discussion about off-label use of drugs in children, an introduction on the operational challenges of clinical trials in children, an overview over other pediatric measures asked in PIPs (modeling & simulation, juvenile animal studies, pediatric formulations), and an introduction into the negotiations procedure of the PIP. Requirements and approval process of PIPs Background: the history of the discussion of better medicines for children Getting PIP waivers The PIP lifecycle: modification of PIPs PIP after approval: pediatric annual reports, Compliance Checks, EU patent (SPC) prolongation Case studies Best approaches in PIP negotiation Pediatric Requirements in Asia Dr. Klaus Rose, CEO, Klausrose Consulting, Switzerland Dr. Klaus Rose is CEO of klausrose Consulting, Switzerland, advising on pediatric drug development and how to comply with FDA & EMA pediatric requirements. After postgraduate clinical training in General Medicine he joined pharmaceutical industry in He held various positions in R&D and medical affairs, was Global Head Pediatrics Novartis and Global Head Pediatrics Roche After a year with a regulatory consultancy he established his own business. He has authored 2 books on pediatric developments one which was released in 2010 and another in 2013.

5 25 28 March 2014 The Westin Beijing Chaoyang, Accelerating Drug & Clinical Trial Approvals in & East Asia and East Asia s rapidly evolving and changing regulatory requirements can cause timeline delays in getting approvals, ultimately impacting pharmaceutical businesses. Due to the differences in various regulations, a good grasp of local regulatory knowledge is the key to success in any new market. IBC Asia s Pharmaceutical Regulatory Affairs Summit will be held in for the second time with an East Asian focus. This conference ensures that you go home with a firm knowledge in the regulatory environment by hearing and learning from the experience of regional and international regulatory experts to ensure maximum business performance and success in entering the Asian market. Key Conference Highlights: Variety of Product Guidelines including Biosimilars, fixed dose combination products, OTC, Orphan and Vaccines Latest Regional and Global Country Updates Industry Best Practices Case studies Opportunities to fast-track drug approvals and clinical trials Hot topics in ensuring Pharmaceutical Safety Ideal Networking Opportunities with Industry Experts and Peers Key Insights into the East Asian Regulatory Environment and Market Who You will Meet : 50% Korea: 10% Japan: 10% Hong Kong 5% Taiwan 5% India & Southeast Asia: 5% US/Europe/Australia: 15% Regulatory Bodies & Pharmaceutical companies: 70% Medical device companies: 10% CROs and research institutes: 10% Legal/Consultants/Service Providers: 10% Directors, Managers, VPs, Presidents, Specialists, Executives, Head of Departments from: Regulatory Affairs Regulatory and Medical Affairs Regulatory Compliance Regulatory Strategy Regulatory Submissions Drug safety and Pharmacovigilance Regulatory CMC Clinical Development and research Product Registration Regulatory Affairs and Market Access Companies that have attended in the past include: Abbott Allergan AstraZeneca Bayer Healthcare Baxter CSL Behring Dr Reddy s Rohto GSK Astellas Pharma Inc Lundbeck Lupin Boehringer-Ingelheim Nycomed Beaufour- Ipsen (Tianjin) Pharmaceutical Ltd Pfizer Merck Eisai Takeda Sanofi-Aventis Daiichi Sankyo Genzyme Eli Lilly Hospira Biogen Hangzhou Tigermed Consulting Co Ltd Covance Teva Pharmaceuticals Procter & Gamble TTY Biopharm Co Ltd Venturepharm Laboratories Ltd Hanmi Pharmaceutical Co Ltd Daewoong Pharmaceuticals Co Ltd Novartis Inqpharm Group INC Research Ltd Amgen Development K K plus many more! SPONSORSHIP OPPORTUNITIES RAISE awareness of your products and services to regional and international regulatory professionals! Stand out from the competition with this branding opportunity Meet and develop new client relationships and also affirm existing ones with your presence at this event Launching a new regulatory service? Ensure market awareness by showcasing at this event Raise and maintain corporate profile with logo placement To check out our tailored sponsorship solutions, please contact: Yvonne Leong, Business Development Manager at (Tel): or ( ): [email protected]