Vivekanand Education Society’s College of Pharmacy (VESCOP), Mumbai, in collaboration with Hanura Therapeutics, H.A.B.I.T. Foundation and AIPFC (Association IP Facilitation Centre), organised an international workshop on ‘Regulatory Milestones in Drug Development’.
The workshop brought together experts from the pharmaceutical industry, regulatory agencies, scientific research and intellectual property sectors to discuss the drug development process, from laboratory research to commercialisation.
The panel comprised Dr Manoj Jadhav, CEO, Isha Therapeutics, New Jersey, USA; Dr Nitin Mali, pharma industry expert, Mumbai; Dr Sripathi Rao Kulkarni, Senior Principal Scientist, CSIR Innovation Complex, Mumbai; Nilesh Patil, Assistant Controller, Indian Patent Office; and D. R. Gahane, former Joint Commissioner, FDA. The session was moderated by Dr Anand Chintakrindi, Associate Professor, VESCOP.
Discussions covered drug discovery, research translation, clinical development, regulatory approval, patent protection and commercialisation, along with differences between Indian and US regulatory frameworks.
Dr Manoj Jadhav also conducted a hands-on case study, enabling participants to apply regulatory principles to drug development scenarios.
Dr Supriya Shidhaye, Principal, VESCOP, said the workshop aimed to help students understand the regulatory pathway and the role of regulatory, scientific, industrial and intellectual property stakeholders in drug development.
Dr Prakash Lulla, Trustee and Treasurer, Vivekanand Education Society, said the initiative was intended to connect academic learning with industry practices and strengthen industry-academia collaboration.
The workshop was coordinated by Shri Vijaykumar Shivpuje, Director, Patlex Business Solutions. At VESCOP, event logistics, participant coordination and public relations were handled by Dr Anand Chintakrindi, Dr Sonali Munj, Assistant Professor, and Dr Shivali Tank, Senior Scientist, Isha Therapeutics.
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