Master of Pharmacy (M.Pharm) in Pharmaceutical Regulatory Affairs
R. C. Patel Institute of Pharmaceutical Education and Research (RCPIPER), Dhule
Dhule, Maharashtra, India
Drug Regulatory Affairs
Savitribai Phule Pune University (SPPU)
- The key task of the department is to train the postgraduate students in Regulatory Submissions, Annual Reports, Registrations and Listings, which will offer first-rate opportunities to students with high quality educational experience. M. Pharm in Regulatory Affairs recently started with the aim to provide a deeper understanding of pharmaceutical product regulatory submission process to USA, Europe, Japan, Australia and Canada etc. Department’s laboratory facilities include well equipped computer lab with Industry required, necessary softwares. The department endows wide opportunity to students and teaching staff to learn and analyse using software independently during academic curriculum.
- The regulatory affairs (RA) department of a pharmaceutical company is responsible for obtaining approval for new pharmaceutical products and ensuring that approval is maintained for as long as the company wants to keep the product on the market. It is responsible for activities to assist in regulatory submission, annual reports, registrations and listings. Assure compliance with applicable medical device regulations per jurisdiction, guidance and standards.
- Regulatory affairs officers act as a link between companies and regulatory authorities, ensuring that products are manufactured and distributed in compliance with appropriate legislation.
- Regulatory affairs officers ensure that products such as cosmetics, pharmaceuticals, and veterinary medicines meet legislative requirements.
Dr. S. J. Surana
- Students who have passed B.Pharm from approved college only are eligible for admission to M.Pharm. They Must have obtained at least 50 % marks in B.Pharm (for researvation and sponsored candidates 45%).
- Candidate should be an Indian National and who possess Bachelors degree or equivalent in Pharmacy from an AICTE approved institutions, with at least 5O% marks (at least 45% marks in case of SC/ST category & Physically Handicapped candidates belonging to Maharashtra State only).
BPharm (Bachelor Of Pharmacy)
- Should have Non zero Score in MAH-MPH-CET if the candidate has neither appeared for GPAT nor having valid and qualified GPAT score.
- LC/TC of HSC.SSC Mark sheet Secondary and Higher Secondary Board
- HSC Mark sheet / Diploma Marksheet Secondary and Higher Secondary Board
- LC/TC of HSC School / College
- HSC / Diploma Passing Certificate Technical Examination Board
- Bonafide and Character Certificate School / College
- Proof of Nationality (Any one of following Original Certificate in English)
- Certificate of Nationality Divisional / District Magistrate
- The School leaving Certificate indicating the Nationality of the candidate as ‘Indian’.
- Indian Passport in the name of the candidate, issued by appropriate authorities.
- Birth Certificate of the Candidate indicating the place of birth in India.
- Domicile Certificate of candidate Executive Magistrate/ Mamlatdar / Tehsildar
- Domicile Certificate of father / mother /candidate (for Type A and Type B candidates) Executive Magistrate/ Mamlatdar / Tehsildar
- Migration Certificate (for OMS / Other university Candidate) Concern Board / University
- First Attempt/Trial Certificate School / College
- Affidavit regarding Gap (if any) On stamp paper of Rs. 100 and affidavit in front of Executive Magistrate
- Gujrathi Linguistic Minority Affidavit (if any) On stamp paper of Rs. 100 and affidavit in front of Executive Magistrate
- Caste Certificate (if applicable) Execute Magistrate of Maharashtra State
- Caste Validity (if applicable) Divisional Social Welfare office/ Director Tribe Scrutiny Committee
- Non Creamy layer (if applicable) Execute Magistrate of Maharashtra State / Collector of district
- CET score card DTE, Mumbai
- CAP Allotment letter DTE Mumbai / AUPPC
- GPAT Score Card Examination of Authority of GPAT