Indian and European Regulatory and Quality Summit 2019

A collaboration between TOPRA and India's Association of Regulatory Affairs, this inter-regulatory conference with a theme of 'Thriving in a Globalised Regulatory Environment' will address recent changes introduced by Indian and European regulators.

 

When: 14–15 November 2019
Where: The Park Hotel, 15 Sansad Marg, Hanuman Road Area, Connaught Place, New Delhi - 110001, India


ARAP Event Logo


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
When
14/11/2019 - 15/11/2019
Where
The Park Hotel 15, Sansad Marg, Hauman Road Area Connaught Place NEW DELHI 110001 INDIA
Your company name
Your VAT country
Your VAT number
NOTE
Important instructions before booking - If your company name or VAT number does not appear here or you would like to be invoiced using a different VAT number, please email finance@topra.org

Register now