When: 14–15 November 2019
Where: The Park Hotel, 15 Sansad Marg, Hanuman Road Area, Connaught Place, New Delhi - 110001, India
Topics will include:
- Overview on registration process and implementation timelines for Newly Notified Medical Devices
- Materiovigilance and Recall process of Notified Medical Devices: an Indian perspective
- OTC - Market and need of regulations in India
- The Role and implication of ICH-E5 & E17 to New Drug Development and the Design of Global Clinical Trials
- Challenges in current operating environment- Falsified Medicines Directive, a case study
- How industry in India handles orphan indications and the implications of the inclusion in the New Drugs and CT rules
- and many more!
Speakers will include:
- Mohammad Ameel, Senior Consultant NHSRC, Ministry of Health and Family Welfare, Government of India
- Dr Reba Chhabra, Deputy Director, Quality Control (Diagnostics), National Institute of Biologicals
- Vipul Kumar Gupta, Associate Director, Corporate Affairs, Cipla
- Dr V Kalaiselvan, Principal Scientist Officer, Indian Pharmacopoeia Commission
- Finny Liu, APAC Regional Regulatory Policy Lead, Roche Singapore
- Dr Sanjeev Miglani, Director, AWINSA Life Sciences
- Dr Mohd Amin Mir, Director Clinical Research, Venus Remedies Ltd
- Arun Mishra, Executive Vice-President, Regulatory Affairs, GlaxoSmithKline Consumer
- Dr KLK Paranjothy, Principal Scientist
- Dr VG Somani, Drugs Controller General of India
For more information and to register, visit ARAP – Summit 2019