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JSS College of Pharmacy, Mysore

Pharmacy Council of India, New Delhi sponsored FDP on Teaching Regulatory Affairs for M.Pharm Programme

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The Faculty Development Programme (FDP) started with the inauguration. Dr. B. Manjunatha, Registrar, JSS Academy of Higher Education and Research was the Chief Guest, Dr. Krathish Bopanna, President & Chief Executive Officer, Semler Research Centre, Bengaluru and Mr. Umesh Baikunje, Founder - Baikunje consultancy, Bengaluru were the Guests of Honor; Dr. T.M. Pramod Kumar, Principal, JSSCPM presided the occasion and Dr. D.V.Gowda, convenor of FDP were present in the inaugural program. Dr. T.M. Pramod Kumar, Principal, JSSCPM welcomed the gathering and briefed about the objectives of the FDP. The chief guest and guests of honour highlighted the importance of Faculty development program and the need in the current scenario. During the inaugural session, “Pharma Regulatory Compendium”, a compilation of achievements of the Regulatory Affairs Group at JSSCP, Mysuru was unveiled by the guests. The guests appreciated the journey of Regulatory Affairs Program in the institution. Dr. D.V. Gowda proposed the vote of thanks. Seventeen (17) participants from different Pharmacy institutions across South India participated in the FDP. The objective of FDP was to appraise the participants about ? Basic elements of regulatory sciences ? Documentation and clinical practices for regulatory approvals ? Regulatory requirements for US, EU, UK, Australia and ROW countries ? Provide Hands-on-training on eCTD compilation and submission The first four days of the program was based on the deliberations from the experts in the focussed area; the sessions were interactive providing simple and actual examples to make the concept clear and easy to understand; Question and Answer round at the end of each session gave clarity on the related learning outcomes. The FDP program was able to cover most of the important topics listed in the Regulatory Affairs subject of M.Pharm – Pharmaceutics course. All the topics were well described, discussed, deliberated and appreciated by the participants. They expressed their satisfaction at the end of each session which was coupled with feedback reports. The participants visited JSS Hospital at Mysuru, an 1800 bedded super-speciality hospital to understand the clinical pharmacy related activities including the conduct of clinical trials and its documentation. The participants were apprised of the good practices in the hospital. It was well accepted and appreciated. The last two days focussed on providing Hands-on-training on eCTD software (PharmReady®) by Navitas LLC, Chennai. A session about the history of electronic submissions was provided to understand the regulatory submissions; fundamentals of eCTD and differences between various types of submissions were provided which paved for the easy understanding of requirements. The FDP concluded with the formal valedictory; the occasion was graced by Dr. T.M. Pramod Kumar, Principal and Dr. P.K. Kulkarni, Vice Principal of the college. A vote of thanks was proposed by Dr. M.P Venkatesh followed by a feedback from the participants about the programme. The Principal and Vice Principal also addressed the participants and gave away certificates, copies of all the presentations and the study material related to the subject. Dr. Balamuralidhara and Dr. M.P. Venkatesh, Asst. Professors of Pharmaceutics department were the co-convenors of the program who took the lead from concept to conceptualization of this FDP program. The faculty development programme was altogether a learning process for everyone. It was a learning experience and it created an opportunity to interaction with experts from various industries. It was a week of knowledge which the participants and the students experienced and cherished. We thank Pharmacy Council of India, New Delhi for generously supporting these activities of the institution. We thank JSS Academy of Higher Education and Research for encouraging the planning and conducting Faculty Development Program.

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