9th Annual Clinical Trials Summit 2018 KEY THEMES DISCUSSED:- Current challenges and regulations for clinical trials in India Having a positive impact on overall market to globalize trials and growth in new product development in emerging countries Formulating a risk-based inspection plan for advanced clinical trials New tools and technologies for data capture for clinical trials Developing effective partnerships and vendor relationships Dealing with the evolve business frameworks that allows third-party vendors, CROs, and sponsors to formulate traditional contracts for contemporary trials Efficient administration for outsourced site contract negotiation Necessary strategies to implement the maximize value of the collaboration. Patient and clinical site centricity: Optimising the end users, patients and the clinical sites Understanding the needs of both patients and the clinical site that should be considered Encouraging data analytics for next-generation clinical trials Leveraging advanced data analytics and m-health for next-gen trials EHR (Electronic Health Records) for clinical research facility Recent guidelines issued by FDA on the use of EHR data Major roles of clinical pharmacology in drug discovery and development Exhibiting and simulating the overall drug development process New clinical trials rules and its impact Current requirements of Indian Clinical Trial Application (CTA) and how this will change with the new clinical trial regulation Regulatory considerations in India and south-east Asia Be part of a major networking opportunity KEY SPEAKERS:- OMPRAKASH S. SADHWANI, Joint Commissioner (Nashik Division), Food and Drugs Administration (M.S.) K. BANGARURAJAN, Joint Drugs Controller (INDIA), CDSCO (HQ) NILIMA A. KSHIRSAGAR, National Chair Clinical Pharmacology, ICMR Govt. of India MUZAFFAR AHMAD, Member Strategic Advisory Board on Health Millenium Alliance (Govt of India) and Member Council of India JAMILA JOSEPH, Senior Vice President and Head Clinical Research Services, Reliance Life Sciences DEVEN V PARMAR, Vice President & Head Clinical R&D, Cadila Healthcare ARUN BHATT, Consultant - Clinical Research & Development CHIRAG TRIVEDI, Director & Head of Clinical Study Unit, Sanofi-Aventis DILIP PAWAR, Director and Head - Clinical Development and Medical - Emerging Market including APAC, Merck Sharp & Dohme SHIRAZ KANDAWALLA, Associate Director - Regulatory Affairs, Abbott BINDU AJIT, Program Director, Biocon Academy AMMAR RAZA, Country Medical Director & Chief Medical Office, Allergan KEDAR SUVARNAPATHAKI, Head - Regulatory Affairs & IP, Boehringer Ingelheim SIDDHARTH DESHPANDE, Assistant Professor Department of Clinical Pharmacology, KEM Hospital AGAM SHAH, Head Clinical Operations, Wockhardt JYOTSNA PATWARDHAN, Head Development QA, Novartis CHIRAG TELI, Head of Medical Services, Alkem Laboratories AMEY MANE, General Manager - Medical Affairs, Janssen India (Pharmaceutical companies of Johnson & Johnson) SUJAY SURESH KULKARNI, Senior Manager - Medical and Regulatory Affairs, GSK PRANJAL BORDOLOI, AVP - Medical Affairs and Pharmacovigilance, Veeda Clinical Research PRASHANT BODHE, Director, CliniSearch WHO SHOULD ATTEND:- CEO's, CTO's, CIO's, Presidents, Vice Presidents, Directors Heads & Managers of: Clinical Research & Development, Clinical Research Services, Clinical Operations, Clinical Data Management, Clinical IT, Clinical Trials, Medical Affairs, Regulatory Affairs, Compliance, Quality control / Assurance/GCP, Clinical Study Design, Safety Surveillance, Subject Recruitment, E-Clinical Systems WHY SHOULD YOU ATTEND? Get more from the event, with a broader scope bringing the whole communications value chain together. Enjoy and make the best out of our dedicated networking time, meet the leading international vendors showcasing the products of tomorrow in the co-located exhibition. Expand your knowledge of the latest business models and strategies in the high-level conference.