FEATURING TOP REGULATORS AND PHARMA LEADERS. Dr. Akshaya S. Odak Head - Regulatory (Biotech) LUPIN, India

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1 IBC LIFE SCIENCES TEAM REGISTRATION BENEFITS! SEE REGISTRATION PAGE FOR DETAILS. PART OF 3 Co Located Conferences 45+ Expert Insights 200+ Total Participants KEYNOTE: Chief Commons Officer, Sage Bionetworks, Senior Fellow, Ewing Marion Kauffman Foundation and FasterCures, USA, TEDGlobal 2012 Speaker on Let s Pool Our Medical Data FEATURING TOP REGULATORS AND PHARMA LEADERS Milan Paleja Country President and General Manager Novartis, Indonesia Anu Mahashabde Senior Director, Global Established Pharma Regulatory Strategy Pfizer, United States Li Ling Liu Director, Good Registration Management (GRM), Researcher & Deputy Director General Minister Office, Chinese Taipei Food and Drug Eva Kopecna Senior Director Generics Regulatory Affairs Global OTC Teva Pharmaceuticals International GmbH, Switzerland Dr. Akshaya S. Odak Head - Regulatory (Biotech) LUPIN, India May (Chunfang) Wei Vice President, Head of Regulatory, CMC and Production Moleac Vicky HAN Senior Director Regulatory Policy Group Lead for Asia Pacific, GRA Jansen Pharma, Singapore Jack Wong Head of Regulatory Affairs Life Sciences, APAC, Baxter Healthcare (Asia) Secretary, Asia Regulatory Professional Association (ARPA) Qing Xi Senior Director, Government Affairs, Market Access & Communications Pfizer, China Claire Chin Associate Director, Regulatory Affairs, SEA & APAC Hub Allergan, Singapore KH Tan Country Head of Legal & Compliance Novartis, Malaysia Rakesh Chaurasia Head-Regulatory Affairs PT. Dexa-Medica, Indonesia Dr. Asmaa Asim Head of Regulatory Affairs ROPU South East Asia & South Korea (SEASK) Boehringer Ingelheim, Singapore Dr. Merricc Edgar-Hughes, Country Head of Regulatory Affairs ANZ, Pharmaceutical and Consumer Health, Bayer, Australia Rie Matsui Director, Regional Labeling Head of Asia Pfizer Japan Inc PRODUCED BY: BRONZE SPONSORS: CO-LOCATED WITH: September 2017 One Farrer Hotel & Spa, Singapore

2 CONFERENCE DAY ONE WEDNESDAY 20 SEPTEMBER, :00 Main Conference Registration Opens & Morning Coffee 9:00 Chairperson s Opening Remarks PHARMACON PLENARY INDUSTRY THOUGHT LEADERSHIP 9:10 KEYNOTE: From Trials to Table The Move Towards a More Patient-Centric Approach Chief Commons Officer, Sage Bionetworks, Senior Fellow, Ewing Marion Kauffman, Foundation and FasterCures, USA, TEDGlobal 2012 Speaker on Let s Pool Our Medical Data seeks to transform and innovate medical research by accelerating data sharing between clinical studies. As the Chief Commons Officer at Sage Bionetworks, he is in-charge of figuring out how to design policies and technologies that allow health and biological data to be broadly share between patients, clinicians and data analysis. Sage Bionetworks has put their open source toolkit innovation to the test by designing an application to conduct a set of Sage Bionetworks mobile research studies enrolling more than 100,000 participants in less than two years and integrated into more than 25 studies outside of Sage, including the US Precision Medicine Initiative. To view John s talk at TEDGlobal 2012, click here 9:40 Drug Development, Pricing and Access bringing together the technical, regulatory and economic considerations Patient centric drug development and access ROI drivers, and outlook for the clinical research and drug development market Regulatory priorities across the pharma value chain Drug pricing developments Regulatory updates - harmonization, new policy, clarity and speed in licensing, submission and approval What are drug development ROIs looking like, and new partnership models for better harnessing ROIs Milan Paleja, Country President and General Manager, Novartis, Indonesia Qing Xi, Senior Director, Government Affairs, Market Access & Communications, Pfizer, China Jean-François Baladi, Senior Executive Director, Health Economics and Market Access, Novartis Pharma K.K., Japan GOVERNMENT ROUNDTABLE INDUSTRY ROUNDTABLE 10:30 Close of Opening Plenary followed by Morning Tea 10TH ANNUAL PHARMACEUTICAL REGULATORY AFFAIRS ASIA CONFERENCE COMMENCES REGIONAL GOVERNMENTS KEY REGULATORY ISSUES UPDATE 11:20 Regulatory Priorities and New Initiatives Areas earmarked for collaboration on harmonisation Plans for reducing drug approval timelines and back logs Regulations on trial guidelines, devices, safety, approval and market access Noncompliance trends and how industry can improve More Regulators to be Confirmed 12:00 Regulatory Update on Good Registration Management (GRM): Recent Trend of Pharmaceutical Regulations A Snapshot of Good Registration Management (GRM) Taiwan s current pharmaceutical regulation policies and what future holds Update on promotion of Good Registration Management (GRP and GSP) in APEC Case study: GRM Pilot CoE workshop: Reviewers training Good Submission Practice Guideline for Applicants Government s initiatives in pharmaceutical industry 12:30 Networking Lunch 13:30 Indonesia s NADFC Perspective on Establishing Bio Product Facility A Focus on GMP Requirements Current regulations on establishment of bioproduct facilities in Indonesia GMP requirements - does it has specific requirements for biosimilar? Working with Government for successful implementation HARMONIZATION AND COMPLIANCE 14:00 Effective Regulatory Compliance strategies, and a wish list for Government intervention Current priorities in regulatory compliance Key areas of noncompliance, and frameworks to manage them Harmonisation the main areas of challenge How is Pharma working around this? Expectations from Government Rakesh Chaurasia, Head-Regulatory Affairs, PT. Dexa - Medica, Indonesia Jack Wong, Head of Regulatory Affairs Life Sciences, APAC, Baxter Healthcare (Asia) Pte. Ltd. Secretary of Asia Regulatory Professional Association (ARPA) INDUSTRY DIALOGUE 14:40 Pfizer s Case Study Patient Information Leaflet and Labeling Trends in Asia How does Regulation view it? Update on patient leaflet and labeling in market What is the possibility that patient labeling will be required in more markets in Asia, and regulations surrounding it? Preparing lay terms - challenge and solutions Labeling regulations changes, what more can industry expect? Rie Matsui, Director, Regional Labeling Head of Asia, Pfizer Japan Inc. Anu Mahashabde, Senior Director, Global Established Pharma Regulatory Strategy, Pfizer, United States 15:00 Avoiding Labelling Misprints: The Truth Behind the Labelling Review Process Dr. Jutta Hohenhoerst, Senior Account Manager, Schlafender Hase GmbH, Germany 15:30 Afternoon Networking & Refreshment Break APPROVALS, SUBMISSION AND REGISTRATION 16:00 Accelerated Approval Pathways Opportunities and Challenges New collaborative approaches to testing the efficacy and effectiveness of new improved medicines Early patient access to innovative therapies that address unmet medical need Impact of accelerated regulatory pathways on drug development and regulatory review process Accelerated approval pathways in Asia Dr. Asmaa Asim, Head of Regulatory Affairs, ROPU South East Asia & South Korea (SEASK), Boehringer Ingelheim Singapore Pte. Ltd 16:30 ectd and RPS Worldwide Progress in esubmissions Status update of ectd implementation worldwide with focus on Asia Pacific Wrap-up of ectd Best Practice on Industry and Agency site Implementation status of upcoming new standard RPS Dr. Silke Nolkemper, Director Consulting APAC,Regulatory Affairs Specialist / Pharmacist, EXTEDO GmbH, Germany 17:00 Moderated Q&A session with Heads of Regulatory Affairs Registration, Submission and Approval What next? Dr. Asmaa Asim, Head of Regulatory Affairs, ROPU South East Asia & South Korea (SEASK), Boehringer Ingelheim 17:30 Chairperson s Summary and End of Conference Day One

3 CONFERENCE DAY TWO THURSDAY 21 SEPTEMBER, :00 Chairperson s Opening Remarks Dr Michel Mikhail, International Expert in Regulatory Affairs, International Expert in Biosimilars, Germany GLOBAL REGULATORY DEVELOPMENTS 9:10 US, EU and APAC: Global Regulatory Emerging Hot Topics and Registration Expedited Pathways 4 Expedited Pathways in US Adaptive pathways and PRIME in EU Sakigake in Japan Priority review in China Emerging initiatives in other AP markets: Breakthrough designation in Korea, Expedited Pathway for Prescription Medicine in Australia etc. 9:40 Pharmacovigilance Regulations in Europe and Australia Risk Evaluation and Mitigation Strategy (REMS) vs Risk Minimization Plan (RMP), Periodic Safety Update Reports (PSUR) Submissions, and other updates How what we do in Australia affects Asia Dr. Merricc Edgar-Hughes, Country Head of Regulatory Affairs ANZ, Pharmaceutical and Consumer Health, Bayer, Australia 10:10 Periodic Safety Update Report (PSUR) and Its Submission Requirements A Shift in Paradigm Broadening of PSUR scope by ICH EU process evolution: Making PSUR a tool for holistic view of the B/R - Impact to the industry - Impact to the health authority/ Assessor - Impact to the prescribes and patients PSUR submission requirements of Ex-EU countries including Asian countries. - What has been accepted so far by Ex EU countries for harmonization of region wise PSUR - Scope of further harmonization of PSUR; region wise, MAH wise, MAH internal process wise Sutirtha Roy, Global Program Regulatory Manager, Novartis Healthcare 10:40 Morning Networking & Refreshment Break 11:10 Learning from the Medical Device Industry Latest Update on Medical Device Regulatory in Asia Challenges in obtaining medical device product approvals from authorities Developing a product that meets authority s requirement Launching the products in Asia meeting regulatory and compliance requirements Jack Wong, Head of Regulatory Affairs Life Sciences, APAC, Baxter Healthcare (Asia) Pte. Ltd. Secretary of Asia Regulatory Professional Association (ARPA) CHINA AND INDIA 11:40 China Market Highlight: Reducing the Backlog of Clinical Trial and Marketing Applications Clinical Trial Application (CTA) Process and Its Timeline A snapshot on China s current regulatory landscape - approval, licensing, requirements Insights on China s time line on clinical trials process of attaining approval Trial case studies Key regulatory takeaways for China market May (Chunfang) Wei, Vice President, Head of Regulatory, CMC and Production, Moleac REGULATORY STRATEGIES FOR OTC PRODUCTS 13:40 Global Perspective on OTC Product Registration, License, Compliance, Safety and Risk Control Global OTC regulatory strategies - what determines the success? Maintenance & Compliance of OTC products Expectations & Challenges Safety and risk management of OTC products Key challenges during acquisition of OTC products 14:10 Specific Registration and Regulatory Requirement in Myanmar for Pharma Products and Medical Devices Food supplements under OTC Over-The-Counter Medicines Prescription Only Medicines and Controlled drugs Medical Devices San San Win, Regulatory Affairs Manager, Sanofi Myanmar Co., Ltd 14:40 Indonesia Case Study: Specific Requirement for OTC and Prescription Products Registration in Indonesia Classification of Medicine Regulations for Pharmaceutical Sector Real Experience on Dealing with Indonesian Regulatory Authorities Rakesh Chaurasia, Head-Regulatory Affairs, PT. Dexa - Medica, Indonesia 15:10 Afternoon Networking & Refreshment Break THE NEW PHARMA ECONOMY 15:40 Knowing and Mitigating Legal Risk in Digital Applications for Pharma How are digital applications disrupting legal and regulatory landscape? What regulatory affairs managers need to know? How pharmaceutical companies to stay ahead of these changes? Legal risks in highlights Mitigation factors in the age of digital revolution in pharma industry KH Tan, Country Head of Legal & Compliance, Novartis, Malaysia 16:10 Regulatory Developments to Support the Digitization of Pharma Understanding the drivers of risk and complexity of legal issues when digitization occurs Digital content risk in pharma industry Potential opportunities and pitfalls Case study 16:40 Chairperson s Summary of the Day and End of Conference WHAT PAST ATTENDEES SAID! THIS WAS A FANTASTIC GATHERING AND A VERY WELL ORGANIZED EVENT. WOULD LOVE TO ATTEND THIS IN THE FUTURE. KEEP UP THE GOOD WORK RAHUL MONGIA, RESEARCH ASSOCIATE, ICRIER 12:10 Networking Lunch 13:10 Lupin s Case Study: Regulatory Strategies for Biosimilars Development and Regulatory Requirements in India Update of current regulatory requirement from Central Drugs Standard Control Organization (CDSCSO) Criteria for evaluating the safety, efficacy, and quality of Biologic (SB)/ biosimilar Lupin s case study on biosimilars regulatory approval pathways Pipeline of biosimilars focused products on regulated markets Dr. Akshaya S. Odak, Head - Regulatory (Biotech), Lupin Limited, India

4 PRE-CONFERENCE WORKSHOP POST-CONFERENCE WORKSHOP 19 SEPTEMBER 22 SEPTEMBER 9am-5pm Interpretation of Guidelines for Drug Registration through ASEAN Common Technical Document (CTD) The differing regulatory requirements across Asia are often seen as one of the key hurdles in drug development. This spans from clinical and CMC requirements through to dossier format and mode of submission. While many countries accept ICH CTD, some prefer ACTD (ASEAN CTD) and others have a string of country-specific documents to be completed. Despite the general topics covered in CTD being similar or common, there are differences in country interpretation of guidelines and the level of information required. This means the need to develop country-specific dossiers. This workshop aims to encourage participants to share their experience in dossier preparation and serve as a good learning exchange platform to share best practices. WORKSHOP LEADER: Claire Chin, Associate Director, Regulatory Affairs, SEA & APAC Hub, Allergan Singapore Claire Chin holds a Master of Pharmacy from UCL School of Pharmacy, University of London. With more than 12 years of experience in the healthcare industry in Asia and Europe, Claire has diverse global regulatory experience and supported a wide range of therapeutic areas that cover both pharmaceutical products and medical devices. Apart from regulatory affairs, she has also been instrumental in building up the pharmacovigilance function in one of her previous roles. 9am-5pm Accelerating Drug Approval in Asia: Overview of Time-Frames and Drug Registration Procedures This interactive workshop is aimed at all professionals with an interest in regulatory affairs in the ASEAN region. The interaction will feature exchange of practical insights and experience with colleagues. The level of detail in this workshop and interactions will provide a useful extension to the main conference. By attending this full day workshop, participants will share experience and gain: A greater understanding of ASEAN harmonization initiatives and level of implementation across the region An overview of requirements for country-specific submissions: the do s and don ts Insights for planning approval timelines into your regulatory strategy Details about time frames, requirements essential for approval WORKSHOP LEADER: Dr Michel Mikhail, International Expert in Regulatory Affairs, Germany Dr. Michel Mikhail has more than 25 years Pharmaceutical Industry experience in Senior roles, with a track record of achievement in R & D and International Regulatory Affairs in large multinational Research-based pharmaceutical companies as well as in the Generic & Biosimilars industry. WHO YOU WILL MEET BY INDUSTRY Pharma/Biopharma/Biotech...60% Government... 15% Medical Device...10% CROs...10% Consultancies/Academia... 5% BY GEOGRAPHY Singapore... 45% Malaysia / Indonesia /Thailand... 15% Rest of South East Asia...10% North Asia...20% Australia/New Zealand... 5% US/Europe... 5% TOP REASONS TO ATTEND Regional Government updates on new initiatives Drug approval bottlenecks - And how to work with regulators to optimise timelines Key insights on product registration, submission, pharmacovigilance, clinical regulatory requirements to be addressed Practical regulatory advice and strategies for OTC drugs, biologics & biosimilars, controlled drugs, API and medical device Pharmacovigilance Regulations - REMS vs RMP, PSUR Submissions, and other updates New pharma economy address on digital applications, and digitization to mitigate legal risk Country Case Studies from Pharma on interpreting and working with local regulations MEDIA PARTNERS: INTERNATIONAL MARKETING PARTNER:

5 WITH A 9-YEAR TRACK RECORD OF SUCCESSFULLY BRINGING TO MARKET THE LATEST DEVELOPMENTS AND INSIGHTS FROM DECISION MAKERS, THE PHARMA REGULATORY AFFAIRS SUMMIT REMAINS THE ONLY SUCH CONFERENCE IN ASIA. Part of the PharmaCon suite of events, the conference affords you the opportunity of getting hot of the press information and networking across various pharma industry segments. PHARMACON ASIA AT A GLANCE Pre Conference Workshop Conference Day 1 Conference Day 2 Opening Plenary Sessions September 2017 One Farrer Hotel & Spa, Singapore September 2017 One Farrer Hotel & Spa, Singapore Networking Cocktails Post Conference Workshop THOUGHT LEADERSHIP KEYNOTE! Chief Commons Officer, Sage Bionetworks, Senior Fellow, Ewing Marion Kauffman Foundation and FasterCures, USA, TEDGlobal 2012 Speaker on Let s Pool Our Medical Data seeks to transform and innovate in medical research by accelerating data sharing between clinical studies. As the Chief Commons Officer at Sage Bionetworks, he is in-charge of figuring out how to design policies and technologies that allow health and biological data to be broadly shared between patients, clinicians, and data analysts. Sage Bionetworks has put their open source toolkit innovation to the test by designing an application to conduct a Parkinson s disease study that aims to attract 18,000 participants, 10 times larger than the biggest study on this condition. View John s talk at TEDGlobal 2012 here PARTNERSHIP OPPORTUNITIES NOW AVAILABLE! STRATEGIC BRANDING NETWORKING FUNCTIONS ONSITE BRANDING PRODUCT SHOWCASE Profile your organisation as an industry leader and leverage on our integrated marketing campaign to extend your marketing reach. Engage your captive audience at an exclusive event hosted by your organisation. Reinforce your branding and seize the opportunity to enhance your brand visibility at the event. Showcase your products and solutions and engage your targeted audience through the exhibition stands or table displays. For more information about how you can leverage on our events to optimise your marketing budget, and reach your target audience please contact: Ms. Yvonne Leong at Tel: l Yvonne.Leong@ibcasia.com.sg