M.Pharm - Two Year Program: M.Pharm in Drug Development & Regulatory Sciences (DDRS)
![]() by SVKM's NMiMS - Shobhaben Pratapbhai Patel School of Pharmacy & Technology ManagementMumbai |
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Category: Pharmaceutical Sciences | Business Communication | MPharm in Drug Development & Regulatory Sciences (DDRS)
Eligibility: (Pre-requisites) | Candidate must have passed B.Pharm examination with 55% of marks from any of the recognized university. Industry sponsored candidate would be preferred. GPAT qualified candidates will be given additional weightage of 10 marks, in the final merit list. |
Medium of instruction: | English |
Post Graduate course in DRUG DEVELOPMENT AND REGULATORY SCIENCES” (M. Pharm. in DDRS) from 2013-2014
SPP SPTM, SVKM’S NMIMS, Mumbai offers INNOVATIVE, JOB ORIENTED M. Pharm. Course in Drug Development and Regulatory Sciences supported by Industries from Session 2013-14 which has ready Employability in Drugs and Pharmaceutical Industry and Regulatory Agencies in India and Overseas.
Keeping into consideration industries expectations and need, the Course has been framed in Consultation with experts from Industries, academia of repute and Regulatory Agency (FDA) to meet requirements of Trained Persons.
The teaching pedagogy involves experiential learning and creativity.
M. Pharm.(DDRS) is of Two years Duration after B. Pharm.
The areas covered are-Drug Development and Regulations in India and International Requirements (US, UK, EU, WHO, ICH, PIC etc., Drug Development Process and Quality Assurance, Business Opportunities and Regulations, Regulatory Overviews of Biologics , Emerging Business Opportunities (Medical Devices) and Regulatory Overviews, Regulatory Inspections including Environmental Controls, Designs and Validation, Quality System-QbD, Design and Control Space and Documentations.
Second Year covers project work in Industry.
Each area includes case studies and lab experiments.
Board of Studies
Board of Studies for Pharmaceutics and Quality Assurance
Dr. Padma Devrajan, Professor and Head, Department of Pharmaceutical Sciences and Technology, Institute of Chemical Technology, N.P.Marg, Matunga, Mumbai 400019
Dr. Harvinder Popli, Head, Global Licensing , Ranbaxy, New Delhi
Dr. Jayant Khandare, Senior Research Scientist, Pharmaceutical R & D, Nicholas Piramal Research Centre, Mumbai.
Board of Studies for Pharm. Chemistry, Pharm. Biotechnology, Natural Products and Pharm. Analysis
Dr. (Mrs.) Krishnapriya Mohanraj, Bombay College of Pharmacy, Kalina Mumbai
Dr. M. K. Raina, Pharma Consultant, Mumbai
Dr. Supriya Mahajan, Professor in Pharmaceutical Chemistry,C. U. Shah College of Pharmacy, SNDT Women’s University, Juhu Campus, Santacruz (W), Mumbai – 400 049.
Dr. Girish Mahajan, Senior Group Leader, Department of Natural Products,Piramal Life Sciences Ltd.Goregaon (E), Mumbai
Board of Studies for Pharmacology and Clinical Pharmacy
Dr. S. L. Bodhankar, Professor Pharmacology, Poona college of Pharmacy, Bharati Vidhyapeeth University, Pune
Dr. A R Juvekar, Professor, Institute of Chemical Technology, N.P.Marg, Matunga, Mumbai – 400019
Dr. Sanjiv Badhwar, Kokilaben Dhirubhai Ambani Hospital and Medical Research Institute, Mumbai
Value Proposition
The department is actively engaged in following research activities:
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Phytochemical investigation on indigenous plant isolating marker compounds.
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Impurity profiles of known drugs synthesized by different routes.
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Analytical and bioanalytical method development of combination drugs and related substances test for API.
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Hands-on experience on sophisticated analytical instruments
Program Objectives
Specially designed course suitable for job placement in pharma industries & research organizations.
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Experienced and vibrant full-time faculty with expertise in pharmacy education and research areas.
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Regular interactions with industry and research organizations with top bosses/ executives.
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Opportunity to develop with current research trends in Pharma industries
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Need based research in industry related areas.
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Case studies from top industry executives.
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Industry oriented research model with opportunity to have electives of special interest.
Pedagogy
The course is predominantly based on practice and interactions with a strong focus on the healthcare system. This will enable the students to practice pharmacy profession in a strong, skillful and determined manner.
The course is reviewed regularly in consultation with our Board of Studies, which consists of professionals from pharma industry, research, FDA and pharma institutes from all over India. Thus, the course is tailor made to fulfill the requirements in Pharmaceutical sector for growing pharma industries worldwide.
Admission Criteria Process
Candidates will be admitted to the above mentioned program through NMIMS Management Aptitude Test (NMAT – P). The Admission Test and Personal Interview will be conducted only at Mumbai Centre. The admission Test will comprise of objective type question based on sections: Pharmaceutics, Pharmacology, Pharmaceutical Chemistry, Pharmaceutical Analysis and Pharm. English Proficiency. Duration of the interview is 10 -12 minutes. Candidates will be assessed based on achievements/ career orientation, professional knowledge/ skills, commitment to the course, learning orientation/ perseverance and soft skills.
The final merit list will be prepared on the basis of information provided in the application form, categorized as academic/ professional work experience, marks obtained in the written test and personal interview.
Merit list of successful candidates for Stage II as well as the final merit list will be displayed on the NMIMS website and on the Institute’s Notice Board.
Placements
Post graduates from this course will have a dual advantage of the business lineage of SVKM’s NMIMS University and a solid background of the industrial aspects in pharmacy. This advantage will be of immense use to the ever growing pharma industry worldwide.
SPTM has a placement cell. It assists students by providing a platform to enter various Pharma Industries and related organizations. We facilitate the placement activities. Generally, the placement cell, along with student representatives co-ordinate both, industrial training and final placements.
FAQ
- What is the eligibility criterion for M. Pharm (Pharm. Anal.) – Full Time course?Candidate must have passed B.Pharm examination with 55% of marks from any of the recognized university. Industry sponsored candidate would be preferred. GPAT qualified candidates will be given additional weightage of 10 marks, in the final merit list.
- What is the admission procedure for the course?Candidates will be admitted to the program through NMIMS Management Aptitude Test (NMAT – P) followed by personal interview.
- What is the scope for M. Pharm (Pharm. Anal.) – Full Time degree?Various job or research options in the area of analytical method development and stability testing, bioanalytical method development are available pharma companies.
- What are the extracurricular activities carried in SPTM?Annual event Urjja (Cultural event)
Isthmus (Corporate Seminar)
Sports activities
Guest lecture - What is the intake capacity for the course?
- What is the pattern followed for the course?
The course shall extend over two years, consisting of three trimesters in the first year, followed by research work on industry related project and submission of dissertation in the second year. - What are the facilities at SPTM?
Air conditioned classrooms with modern teaching tools, user friendly and well equipped sophisticated laboratories, Pilot Plant, Chemistry Laboratory, Blackboard technology, Animal House, Central Instrumental Laboratory etc. - How would you rate your institute nationally?
NMIMS is one among the top ten Business schools in India, while looking into the infrastructure, faculty, teaching learning and research performances. - Are placements provided by your institute?
We do have a placement cell. It gives platform to students to enter into various Pharma industries. However we don’t work as a commercial placement office. We facilitate placement activities. - What is the duration of course for M. Pharm (Pharm. Anal.) – Full Time course?
Duration of course for M. Pharm (Pharm. Anal.) – Full Time is two years. - What is the process for cancellation of admission?
The candidate should submit a written request for cancellation of admission and submit it to Deputy Registrar (Admissions) along with original fee receipt. The fees refund will be as per the norms laid down by the All India Council for Technical Education (AICTE), from time to time. - Which official statutory bodies have approved these courses?It is not a pre-requisite for an institution notified as a ‘Deemed to be University’ to obtain the approval of the AICTE, to start any programme in technical or management education leading to an award, including degrees in disciplines covered under the AICTE Act, 1987. However, institutions notified as ‘Deemed to be University’ are required to ensure the maintenance of the minimum standards prescribed by the AICTE for various courses that come under the jurisdiction of the said Council. It is expected that the institutions notified as ‘Deemed to be University’ maintain their standards of education higher than the minimum prescribed by the AICTE.
- Is hostel facility available for students?
Yes we do have Hostel facility as mentioned belowHostel facility in Mumbai
Hostel for Girls: NMIMS has a well furnished hostel for girls (limited seats) by the name of MKM Sanghavi Girls’ Hostel, which is located close to the University. Along with this a few residential flats are also available for accommodation.
Hostel for Boys: Limited seats are available at G. R. Jani Boys Hostels, which is 1/2 km away from the NMIMS campus. In addition to this, few residential flats are also available for accommodation.Hostel facility in Shirpur
Being a residential campus, the hostel at our campus is well furnished and fully equipped with all the necessary requirements for students.
Hostel for Boys: NMIMS has a well furnished hostel for boys, which is located in the campus as the campus is a residential campus.
Hostel for Girls: NMIMS has a well furnished hostel for girls, which is located in the campus as the campus is a residential campus.
The additional facilities provided in the hostel are:
Dining facility
Regular cleaning of rooms and washing of cloths
Medical facility attached to hostel
Mumbai campus– 20 seats
Curriculum
M.Pharm- Drug Development & Regulatory Sciences (DDRS)
FIRST YEAR – TRIMESTER – I |
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AREA |
CODE |
SUBJECT |
Regulatory Sciences |
1060 DDR |
Drug Development and Regulations |
Regulatory Sciences |
1061 DDPQA |
Drug Development Process and Quality Assurance |
Management |
534 SPL |
Professional Communication * |
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|
Lab |
TRIMESTER – II |
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AREA |
CODE |
SUBJECT |
Regulatory Sciences |
1062 BPR |
Business opportunities and regulations |
Regulatory Sciences |
1063 ROB |
Regulatory overviews of Biologics |
Regulatory Sciences |
1064 EBOR |
Emerging Business opportunities and regulatory overview |
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|
Lab |
TRIMESTER – III |
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AREA |
CODE |
SUBJECT |
Regulatory Sciences |
1065 RI |
Regulatory Inspections |
Regulatory Sciences |
1066 D & V |
Design and Validation |
Regulatory Sciences |
1067 QSD |
Quality Systems and documentations |
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Lab |
* Non credit course. Passing is compulsory |
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SECOND YEAR PROJECT – WORK AND DISSERTATION |
Classroom - Full Time | ||||
When | Duration | Where | Remarks | Price |
Not Specified |
2 Years |
All Venues | Not Specified | Price On Request |
SVKM's NMiMS - Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management
Shobhaben Pratapbhai Patel School of Pharmacy & Technology Management is a model pharmacy school conducting various graduate, postgraduate and research programs in pharmaceutical sciences.
The school has excellent lab facilities, good teaching and learning practices based majorly on student feedback systems. The school has highly experienced faculty who encourage students to carry out research in the fields of their interest. The courses and their practice are need based and focus on the pharma industry and hospitals.
MISSION
To produce self-motivated and self reliant young pharmacists catering to the needs of Industry,Academia and Research.
To create a centre of excellence for R&D in the field of pharmaceutical sciences with inter disciplinary approach in emerging area of Science and Technology with focus on Industry-Academia interaction and cooperation at National and International level.
To interlink Pharmaceutical Sciences with Biological / life Sciences and Management Education.
To provide Life Long Learning opportunities in Pharm. Sciences
VISION
To develop a model Pharmacy School at International level inculcating research trends in Pharmaceutical Science and Technology Management.