About the Centre:

Today’s changing landscape in drug development requires a change in regulatory practices and the regulatory framework we have constructed to deliver on the promise of bringing efficacious and safe drugs to patients. We work towards this vision by bringing together experts from different disciplines to advance regulatory science nationally and internationally. The research we conduct aims to advance the field of regulatory science in India and globally. Furthermore, the curriculum designed and developed by the centre in the academic program aim to equip and develop the future workforce with the necessary knowledge and professional skills.  Dr. TMA Pai Endowment Chair in regulatory science is providing a seed endowment to the centre.

Academic Activities:

Courses Offered:

Executive course on Drug Development and Regulatory Science:   

Executive Training Program on Drug Development and Regulatory Science is delivered by Centre for Regulatory Science, Prasanna School of Public Health (PSPH), MAHE, European Center of Pharmaceutical Medicine (ECPM), University of Basel, Switzerland and Roche, India.

Eligibility: Experienced employees working in Pharmaceutical ecosystem (biotechnology companies, CRO's, pharmaceutical companies, regulatory agency, government agency, generic industry, academia, etc.) that are looking to specialise in Regulatory Affairs and get a broad overview of current topics and future trends in drug development

Fees:  INR 2,00,000 (For Government employees: INR 1,50,000)

Link to Register: https://tinyurl.com/RegulatoryScience

Last Date for Registration: October 31, 2022

WebinarRegulatory Science Series:

Regulatory aspects of Personalised Healthcare – Global

The webinar was focused on the developments in regulatory science regarding the emerging fields of drug development and personalized healthcare

 

Coordinator:

Dr Lada Leyens, PhD, MSc

Dr T.M.A Pai Endowed Chair in regulatory science, PSPH, MAHE.

Senior Director, EUCAN Regulatory Affairs Team Lead, GI2, Regulatory Affairs, Takeda, Switzerland.

Email id: lada.leyens@takeda.com

Mail us @ regulatoryscience@manipal.edu

News and Events

Executive Training Program on Drug Development and Regulatory Science

Centre for Regulatory Science, Department of Health Information, PSPH, MAHE in collaboration with European Center of Pharmaceutical Medicine (ECPM), University of Basel, Switzerland and Roche India Healthcare Institute, India from February 23, 2023 to November 25, 2023 through online mode, face to face learning and industry visits. Faculties across

academia, regulatory agency such as CDSCO, Swiss medic, EMA and FDA and industry conducted various lectures.

Executive Training Program on Drug Development and Regulatory Science

The organising team of “Executive Training Program on Drug Development and Regulatory Science” embarked on a significant visit to Delhi from January 17 to January 21, 2023. The organising team had key meetings and interactions with the former Director-General of OPPI, Mr. Vivek Sehgal, former Drugs Controller General of India (DCGI) VG Somani and current DCGI Dr Raghuvanshi. The team also interacted with students from NIPER and NMIMS, where Dr. Leyens shared insights on 'Digital Health in Clinical Research.' 

The meeting with  Vice Chancellor of Delhi Pharmaceutical Sciences and Research University, Dr. Rajkiran Jain, Group VP & Head, Global Regulatory Affairs, Glenmark and ICMR phase 1 and phase 2 clinical trial team. This visit underscores the ongoing collaboration and exchange of knowledge between international experts and Indian institutions in the realm of clinical research and pharmaceutical sciences.

During the module 6 of “Executive Training Program in Drug Development and Regulatory Science,” which was conducted from 23 November -25 November 2023, the course participants along with the coordinators of the course had an opportunity to visit various

Government institution in Delhi such as Indian Council of Medical Research (ICMR), Indian Pharmacopoeia Commission (IPC), Central Drugs Standard Control Organisation (CDSCO) and Federation of Indian Chambers of Commerce & Industry (FICCI). This module also included a panel discussion featuring experts from academia, industry, and regulatory sectors. Upon completion of Module 6, participants were awarded their well-earned diploma certificates.

The annual TOPRA Awards for Regulatory Excellence recognize and celebrate accomplishments and exemplary practices in regulatory affairs on an international scale. The ceremony for this year's awards was held on November 29, 2023, at Merchant Taylors' Hall in London. The "Executive Training Program in Drug Development and Regulatory Science" classified under the education category, was honoured with a nomination and was named as a finalist in the competition.