ADVANCE ATTENDEE LIST DEADLINE 30 SEPTEMBER. REGISTER TODAY!

Exhibit DIA 2014 Space Now 9th Annual India Conference Open! The Future of Indian Healthcare: Patients, Access and Innovation

16-18 October Palladium Hotel  Mumbai, India All attendees will receive a DIA Certificate of Attendance diahome.org/India-9thAM at the conclusion of the event.

KEYNOTE SPEAKERS PROGRAM CO-CHAIRS

Padmashree Prof. Ranjit Roy Chaudhury Chairman, Task Force for Research Apollo Hospitals Group

Alexandra Pearce DAY 1 | October 16 DAY 2 | October 17 DAY 3 | October 18 Senior Vice President and Head Global Regulatory Affairs M K Bhan G N Singh Kiran Mazumdar Shaw Glenmark Pharmaceuticals Former Secretary Drug Controller Chairperson and Department of Biotechnology (DBT) General of India Managing Director Govt. of India (DCGI) Biocon PROGRAM COMMITTEE

Abby Abraham Vice President & Co-Founder, PROGRAM OVERVIEW Clinical Solutions, Good health is a fundamental human right. But despite rapid improvements in the recent past, there Algorithm Inc. are unprecedented healthcare challenges in India today that demand immediate attention and action. The most critical aspect among these is ensuring safety, efficacy, quality, affordability and accessibility Vivek Ahuja of medicines and treatment to patients at all times. The key imperatives to overcome these continual Director challenges and catalyze the transformation include putting patients first, fostering innovation, and Research & Development PATH India enhancing access. The DIA 2014 9th Annual India Conference will bring together leading local and global experts in healthcare, pharmaceutical industry members, academia, researchers, regulators, payers and patients under one roof to deliberate on the emerging trends, opportunities and challenges. Alberto Grignolo Corporate Vice President PROGRAM OBJECTIVES WHO SHOULD ATTEND PAREXEL, United States • Focusing on ‘Patient First’ approach and • Drug development and clinical research various patient centric paradigms covering managers and associates • Pharmaceutical physicians and Madhur Gupta innovation and access of Indian healthcare Technical Officer • Hear the views of leading experts from the medical directors Pharmaceuticals academia, government, industry, researchers, • Drug safety and drug surveillance personnel WHO Country Office for India patient representatives and regulators on • Professionals engaged in discovery research current local and global trends and best • Clinical pharmacology scientists practices • Pharmacologists Jaideep Kaneria • Regulatory affairs managers AVP Lifesciences • Bringing all healthcare stakeholders together TCS Services to discuss current issues/topics • Quality professionals • Covering important issues/topics such as, • Academic scientists patient health and safety, pharmacovigilance, • Biostatisticians clinical trial, quality and manufacturing, • Data managers Sowmyanarayan Srinivasan • Medical writers Head, R&D Solutions and Consulting health economics, healthcare delivery, Cognizant Technology Solutions public-private partnership in innovation and • Outsourcing and marketing managers healthcare access, case studies on Indian • IT professionals innovation and many more • Patient Engagement Stakeholders Arun Mishra Director and Head, Regulatory Affairs Support / Exhibiting Companies as of 2 September 2014 Abbott India Ltd.

Goutam Pujari Vice President Head Global Clinical Research Operations Glenmark Pharmaceuticals

Santosh Savarkar Associate Vice President Media Partners as of 2 September 2014 Regulatory Affairs DIA Global Center Alembic 21 Dupont Circle NW, Suite 300 Washington, DC 20036

PUBLICATIONS The Pharma Review® Basel, Switzerland | Beijing, China | Horsham, PA, USA | Mumbai, India | Tokyo, Japan 2

DAY 1 | THURSDAY, OCTOBER 16

8:30–10:00 am REGISTRATION

10:00-10:30 am OPENING CEREMONY

10:30-11:00 am KEYNOTE PRESENTATION M K Bhan Former Secretary Department of Biotechnology, (DBT) Government of India

11:00 am-12:00 pm PLENARY SESSION 1 Patients The opening session sets forth the tone and content of the prevailing thinking and practice in the clinical research and patient care space which is undergoing a paradigm shift. The patients’ voice and perspective is coming to the fore as a definite patient centric approach. The topics will help provide holistic insight to the current issues and orient future thinking.

Session Chair Vikas Sharma JOIN A DIA COMMUNITY! Senior Director Medical Ethics & Research Office of Chief Medical and This exclusive member benefit helps DIA members Scientific Officer stay connected even after the meeting ends! Quintiles DIA Communities allow members to exchange

Panelists information, explore industry hot topics, and grow their professional network. Urmila Thatte Professor and Head Seth G S Medical College and With more than 30 interest-specific areas KEM Hospital to choose from,

Satish Chandra DIA Communities keep you connected. Senior Specialist and Head Clinical Research TAWAM Hospital (associate of John Hopkins) Interact with colleagues from many UAE different disciplines around the globe 24/7

Y K Gupta Professor and Head Keep up-to-date on hot topics and Department of Pharmacology community-generated content and AIIMS programming

Pooja Sharma Share best practices, knowledge Leader (Hon) CANKIDS Patient Advocacy Group and resources, articles and more Senior Scientist, Clinical Research Medanta the Medicity

Hari Menon Professor Department of Medical Oncology Tata Memorial Hospital diahome.org/Community

12:00-13:30 LUNCH AND EXHIBIT VISIT Communities in India: Clinical Data Management Clinical Safety and Pharmacovigiliance 12:30-13:30 WHITE PAPER PRESENTATION - TCS Global Outsourcing Medical Writing Regulatory Affairs 3

CONCURRENT SESSIONS

13:30-15:00 pm SESSION 1A 13:30-15:00 pm SESSION 1B Patient Health Safety and Compliance for Pharmacovigilance in India Prescription Medicine The speakers in this session will describe the status of pharmacovigilance regulation and practices in India, with a focus on monitoring the safe use of This session will address issues surrounding the use of medicines by patients markets drugs and ways to take prompt remedial action when and if necessary; in India, including compliance with prescribed medicines and how to ensure Clinical trial safety regulations to protect safety of clinical trial participant the safe use of medicines. in India, recent changes in regulations, pitfalls and global perspective; PV Session Chair outsourcing industry in India contributing to patient safety globally , also Padmashree Prof. Ranjit Roy Chaudhury increasing PV expertise and awareness in the country. Chairman, Task Force Session Chair Apollo Hospitals Educational and Research Foundation (AHERF) Ajoy Roy Regulatory Initiatives to Enhance Compliance Senior Medical Director and Head Medical Affairs PAREXEL, India V G Somani Joint Drug Controller Postmarketing Pharmacovigilance Regulations and CDSCO Practices in India Preventing Errors in Using Medicines Y K Gupta Professor and Head Pramil Tiwari Dept. of Pharmacology Head and Professor AIIMS Department of Pharmacy Practice NIPER A SWOT Analysis of Growing Pharmacovigilance Industry in India Increasing Medication Compliance in Patients Mangesh Kulkarni Prem Pais Head Safety Operations Professor of Medicine Drug Safety & Epidemiology Head of Division of Clinical Research Training Novartis Healthcare Pvt. Ltd. St. John’s Institute

15:00-15:30 TEA / COFFEE BREAK & EXHIBIT VISIT

CONCURRENT SESSIONS

15:30-17:00 pm SESSION 2A 15:30-17:00 pm SESSION 2B Status of Patient Advocacy Groups in India— Patient Participation in Clinical Trials Panel Discussion This session will focus on the important ethical issues and practical logistics (for example, travel from rural areas) affecting the participation of patients This session will provide current information on the status and influence of in clinical trials in India, the stricter applicable regulations (for example, patient advocacy groups in India, their goals and aspirations, their success videotaped informed consents), the protection of the rights on trial participants and ongoing concerns, and the issues that remain to be addressed to protect and of the validity of the data, and the oversight of clinical investigators. patient safety and promote patient health. Session Chair Session Chair Barbara E. Bierer Mira Shiva Professor of Medicine, Harvard Medical School Founder Member & Advisory Committee Member - Brigham and Women’s Hospital Faculty Co-Director People’s Health Movement, Multi-Regional Clinical Trials Center, Harvard University Former Chairperson - Health Action International Asia-Pacific Participant Understanding and Informed Consent Kimberly Hensle Lowrance Y K Sapru Managing Director Chairman & CEO Public Responsibility in Medicine and Research (PRIM&R) Cancer Patients Aid Association India Return of Summary Results to Participants: Vikas Ahuja Regulation, Content and Process President Barbara E. Bierer The Delhi Network of Positive People, India Professor of Medicine, Harvard Medical School Blessina Kumar Brigham and Women’s Hospital Faculty Co-Director Health Activist & Public Health Consultant Multi-Regional Clinical Trials Center, Harvard University Chair , Global Coalition of TB Activists International Clinical Trials Data Sharing: Principles and Mandate Mark Barnes Partner, Ropes & Gray LLP, Lecturer on Law Harvard Law School, Faculty Co-Director Multi-Regional Clinical Trials Center, Harvard University

17:00 pm MEETING ADJOURNED 4

DAY 2 | FRIDAY, OCTOBER 17

10:30-11:00 am KEYNOTE PRESENTATION G N Singh Drug Controller General of India

11:00 am-12:30 pm PLENARY SESSION 2 Access The plenary session intends to generate directional thought leadership to arrive at a unique and integrated healthcare model. The session will help to analyse and suggest future model which leverages principle of accessibility, affordability and accountability by adopting a patient-centric approach towards delivery of quality healthcare to the Take Advantage of the Benefits masses. The session will also invite opinions from the panel members and participants to understand possible impact and adoption of Health Care Economic Outcomes Research (Pharmacoeconomics), Health Insurance, Public Private Partnerships, that come with having a DIA Membership. Diagnostics & Pharma Industry – covering the Healthcare Value Chain. 55 Members-only conference registration discounts on all DIA Session Chair conferences and offerings across the globe. Nata Menabde WHO Representative to India 55 Members-only free archived webinars - Take advantage of a hot topic webinar as a complimentary member benefit—without leaving your desk.

Panelists 55 Therapeutic Innovation & Regulatory Science - DIA’s peer-reviewed, scholarly journal (formerly the Drug Information Journal) including 40 years of indexed and archived scientific articles—all available online. Swati Piramal (6 issues) Vice Chairman Piramal Enterprise Ltd. 55 Global Forum - your member digital newsmagazine featuring practical tips, regulatory and global updates. (6 issues)

55 Contract Service Organization (CSO) Directory - searchable vendor N K Ganguly and support services directory. Former Director General Indian Council of Medical Research 55 Communities - DIA’s Communities—discipline specific groups that network regionally and globally, share best practices, knowledge resources and the latest information related to your field—all online Devi Shetty and available 24-7. Current Regional India Communities Include: Chairman Narayana Hrudayalaya Group of Hospitals Clinical Safety and Pharmacology | Clinical Data Management Global Outsourcing | Medical Writing | Regulatory Affairs Risk-based Monitoring Scientific Working Group (SWG)

Rajesh Balkrishnan 55 DIA Online Member Directory - Network locally and globally via Associate Professor Health Outcomes DIA ConneX—your platform for sharing documents and discussions, University of Michigan connecting with colleagues and developing your own network of colleagues and industry thought leaders.

Ferzaan Engineer 55 Knowledge resources at www.diahome.org featuring videos, Co-Founder and Chairman podcasts, presentation downloads, publication archives, and robust Cytespace searching and sorting tools to get the information you need, when you need it.

Including DIA’s Global Resources: 12:30-13:30 pm LUNCH AND EXHIBIT VISIT 55 DIA Daily - This daily enewsletter features summaries of breaking news in the pharmaceutical, biotechnology, and medical device fields gathered from thousands of global news sources.

55 SmartBrief - Two times per week, receive the latest news and information related to diagnostic and therapeutic product innovations.

55 Career Center - Search for employment opportunities and submit your resume, all confidentially and online.

MEMBERSHIP RATE FOR RESIDENTS OF INDIA One Year (Digital Access) 1, 950 INR

Your DIA membership features online access to all of the member benefits including DIA’s world-class publications delivered digitally. For more information about membership, please email [email protected]. 5

CONCURRENT SESSIONS

13:30-15:00 pm SESSION 3A 13:30-15:00 pm SESSION 3B Universal Health Coverage and Health Medicine Pricing and Reimbursement Insurance Speakers in this session will illustrate the various existing public and private mechanisms for the pricing and reimbursement of medicines in India, with a The goal of this session is to take stock of the current state and focus on how patients at all income levels can have access to the medicines future prospects for universal health coverage and health insurance they need, on what obstacles may exist to such access, and on possible ways for patients in India, with particular reference to patient access to to remove such obstacles. registered safe and effective medicines. Session Chair Session Chair Manu Sehgal

Indrani Gupta Vice President Professor & Head, Health Policy Research Unit PAREXEL, India Institute of Economic Growth, India Insight into India’s Pharmaceutical Pricing Policy: Will Access to Medicines and Health Technologies in the the Revised Policy Improve Access to Medicines? Context of Universal Healthcare Coverage in India: Opportunities and Challenges Anita Kotwani Madhur Gupta Associate Professor, Department of Pharmacology Technical Officer, Pharmaceuticals Vallabhai Patel Chest Institute WHO Country Office for India University of Delhi, India Universal Health Coverage: Concerns and Options Medicine Reimbursement in India Present and Future Indrani Gupta Anuj Kapoor Professor & Head, Health Policy Research Unit Senior Manager Operations Institute of Economic Growth, India Health Economics & Outcome Research Practice Universal Health Coverage - Scope for Policy and Systems Reform Optum Global Solutions India's medicine reimbursement and market access policy Priya Balasubramaniam in light of experience from Europe and Asia Senior Public Health Specialist Public Health Foundation of India Manu Sehgal Vice President PAREXEL, India

15:00-15:30 pm TEA / COFFEE BREAK AND EXHIBIT VISIT

CONCURRENT SESSIONS

15:30-17:00 pm SESSION 4A 15:30-17:00 pm SESSION 4B Good Manufacturing Practices—Panel Compulsory Licensing—Increasing Tool Discussion for Easy Access of Medicines—Panel Pharmaceutical GMP in modern times is not just an assessment Discussion through testing the finished product but is an ongoing discipline that This session will examine and debate the important and delicate issue one has to be imbibe from product development to product distributed to of compulsory licensing of medicines and both its intended (affordable the patients. GMP poses a significant challenges in terms of bridging access to medicines) and unintended (obstacle to the entry of – What Agency Wants and What Industry Understands. The GMP innovation into India) consequences. session will open with a brief presentation by USFDA Regulator and would lead into a panel discussion covering aspects of GMP Challenges Session Chair for Pharmaceutical/Healthcare industry and the path to be traversed Aliasgar Dholkawala moving forward. Senior Associate, Legal Services PRESENTATION Wadia & Gandhy & Co. Thomas Arista Investigator/National Expert-Biotech Milind Sathe FDA Deputy General Manager, IPM & Projects Unichem Session Chair Alka Mehta Ganadhish Kamat Head IP Executive Vice President, Quality Cipla Lupin Tabrez Ahmad Moderator Secretary General Vikas Dandekar Organization for Pharmaceutical Products of India India Bureau Chief (OPPI) PharmAsia News Ajaz Hussain Smita Karve President & CEO Professor of Law Insight Advice & Solutions Jitendra Chauhan College of Law Nick Cappuccino Chief Technical Officer & Scientific Advisor Dr. Reddy’s Laboratories

17:00 pm MEETING ADJOURNED 6

DAY 3 | SATURDAY, OCTOBER 18 2:00 noon-13:30 pm SESSION 5 Innovation in Drug Discovery and Development :00-10:30 am KEYNOTE PRESENTATION Speakers in this session will illustrate the current status of pharmaceutical innovation in India – from scientific discovery to the development of innovative drugs that Kiran Shaw Mazumdar change the practice of medicine. Can Indian R&D improve its competitiveness on Chairperson and Managing Director world markets? BIOCON Session Chair

10:30-11:00 am TEA / COFFEE BREAK Neelima Khairatkar Joshi AND EXHIBIT VISIT Senior Vice President and Head NCE Drug Discovery & Research Glenmark 1:00-12:00 noon PLENARY SESSION 3 The Need for New Innovative Approaches to New Innovations Drug Discovery A country must nurture a multidisciplinary ecosystem to conceive, support and reward innovation for its people. Increasingly innovation is seen as the currency Mohan D. Nair of the century. Knowledge based economies are now depending on its ability to Consultant to Pharmaceutical Industry generate new ideas, processes and solutions, and converting into social good and Clinical Trials in 2020 economic growth. Innovations could be a way forward delivering affordable and quality healthcare to India’s billion-plus people. The session will explore challenges Rajesh Jain and opportunities for India centric healthcare innovation including drug discovery Director, Life Sciences Business Process Services and development. Cognizant Technology Solutions India Pvt. Ltd.

Session Chair From Innovation to Cure: India Perspective on Today & Tomorrow... Arun Mishra Director and Head, Regulatory Affairs Neelima Khairatkar Joshi Abbott India Ltd. Senior VP and Head, NCE Drug Discovery & Research Panelists Glenmark Padmashree Prof. Ranjit Roy Chaudhury Chairman, Task Force 13:30-14:30 pm LUNCH AND EXHIBIT VISIT Apollo Hospitals Educational and Research Foundation 14:30-16:30 pm SESSION 6 (AHERF) Innovations in Healthcare Solutions This session will address examples of how certain Indian healthcare solutions have Mohan D. Nair been highly innovative and have delivered concrete benefits to millions of patients. Consultant to Pharmaceutical Industry Speakers will address what additional actions need to be taken to expand such innovation to the entire Indian patient population. Session Chair Sudharshan Jain Romi Singh Managing Director Executive Director Healthcare Solutions Amgen Abbott India Ltd. Indigenous Innovation in Medical Technology: Manoj Malhotra An Emerging Paradigm CEO Siraj Dhanani Pyramid Healthcare Founder and CEO Salient Business Solutions, Avantha Group Innaccel Pvt. Ltd. Empowering Frontline Health Workers with Technology Kanav Kahol Division Head Affordable Health Technologies Division Public Health Foundation of India Big Data Analytics for Developing Nations: How Secondary use of EHR Data can Help India Gunjan Jain Principal Sales Consulting Head South Asia Oracle HSGBU

16:30-17:00 CONFERENCE WRAP UP VENUE DETAILS MEETING MANAGER Palladium Hotel, 462 Senapati Bapat Marg, Lower Parel Manoj Trivedi Rajnish Kumar Mumbai, Maharashtra, 400013, India, +1.888.734.8503 Senior Manager cell: +91 98.1909.8457 CONTACT Marketing and Program Development [email protected] Tejarani Pednekar, Reservations, Palladium Hotel DIA (India) Private Limited tel: + 91 22.6162.8000 | fax: + 91 22.6162.8888 cell: +91 98.1977.7493 [email protected] [email protected]

CANCELLATION POLICY: On or before OCTOBER 1, 2014 Cancellations must be in writing and received by October 1, 2014. Registrants who do not cancel in writing by that date and do not attend the SAVE! event will be responsible for the full registration fee paid. Registrants are responsible for cancelling their own hotel and airline reservations. GROUP DISCOUNT DIA reserves the right to alter the venue, if necessary. If an event is cancelled, DIA is not responsible for any airfare, hotel or other Register 10 from your company and receive the 11th FREE! costs incurred by registrants. Contact Manoj Trivedi UPON CANCELLATION, the administrative fee that will be withheld FULL MEETING CANCELLATION [email protected] or from refund amount is 25 % of the delegate fee All refunds will be issued in the currency of the original payment call for details cell +91.98.1977.7493

PLEASE CONSIDER THIS FORM AS AN INVOICE DIA 2014 9th Annual India Conference Meeting I.D. # 14659 | October 16-18 | Palladium Hotel | Mumbai, India

DELEGATE FEE BASIC RATE SERVICE TAX TOTAL REGISTRATION FEES (Residents based in India) (INR) 12.36% (INR) (INR) Registration fee includes refreshment breaks and luncheons. EARLY BIRD BEFORE AUGUST 31, 2014 DIA Membership Join DIA now to qualify to save on future events and to receive all the benefits of membership. Industry Member 9000 1113 10113 Visit www.diahome.org and click on Membership for more details. Industry (Non Member) 11000 1360 12360 *A limited number of NGO, Patient Groups and Students registrations will be available. In order to apply, interested applicants must submit eligibility documents to DIA. Academia/Government 6000 742 6742 NGO’s and Patient Groups Students/NGO/Patients* 4000 494 4494 Eligible individuals must provide supporting document(s) demonstrating their affiliation and AFTER AUGUST 31, 2014 status as an NGO or Patient Group. Industry Member 10000 1236 11236 Student Registrations A student is an undergraduate/graduate who can document enrollment in a signature Industry (Non Member) 12000 1483 13483 accredited, degree granting, academic program. Please send completed registration form, Academia/Government 7000 865 7865 payment and copy of student identification. For additional details, please contact Students/NGO/Patients* 5000 618 5618 Manoj Trivedi, Senior Manager DELEGATE FEE BASIC RATE SERVICE TAX TOTAL ($) Marketing and Program Development [email protected] | cell: +91 98.1977.7493 INTERNATIONAL RATES ($) 12.36% ($) (Residents outside of India) OR Rajnish Kumar Member 300 37.08 337.08 [email protected] | cell: +91 98.1909.8457 Non Member 475 58.71 533.71 *NGO’s /Patient Group & Students must submit eligibility documents to DIA. TOTAL AMOUNT: ______ORGANISATION PAN No.: ______REGISTRATION TERMS AND CONDITIONS: Registration form should be duly filled, signed by the authorized person. You are requested to email the duly filled and signed Registration Form first and then courier/mail it along with registration fees on or before 5 working days of the conference.

Please check the applicable category: PAYMENT DETAILS PAYMENT INFORMATION Account Name: Completed form, along with draft/ PLEASE PRINT ALL INFORMATION CLEARLY q Academia q Industry q Student DIA (INDIA) PRIVATE LIMITED cheque made payable to DIA (India) Account No: 061010200024611 Private Limited should be sent to: Bank Name: AXIS BANK LIMITED Bhavesh Vora Degrees: q Dr. q Mr. q Ms. Senior Executive Accounts Branch Name: Dhiraj Baug, [email protected] Near Hari Niwas Circle, LBS Marg, Drug Information Association Thane (W) - 400602 Last Name (Family Name) A- 303, Wellington Business Park 1 IFSC Code: UTIB0000061 Andheri Kurla Rd. Marol Naka, Andheri East MICR Code: 400211013 Mumbai 400059 INDIA First Name Swift Code: AXISINBB061 tel: +91 22.6523.0676 cell: +91 98.2097.2630

Job Title

Affiliation (Company)

Address (Please write your address in the format required for delivery to your country.) q Business Address q Home Address

Postal Code City State Country

Telephone Number Fax Number Mobile Number

email (Required for confirmation) Signatory

Payment contact person’s Full Name Telephone Number email