New Collaborative Certificate Programme in Pharmaceutical Regulatory Affairs and Quality Control (RAQC) by School of Pharmacy & Technology Management (SPTM) of SVKM's NMIMS University, Mumbai in association with Seneca College, Toronto

International Academic Partnership

The Academic Partnership between School of Pharmacy & Technology Management (SPTM) of SVKM's NMIMS University, Mumbai and Seneca College of Applied Arts and Technology, Canada has resulted in a pioneering international collaborative programme in Pharmaceutical Regulatory Affairs and Quality Control (RAQC).

About Seneca College, Toronto

• Seneca is Canada's Largest Government Funded and Government Accredited College with Campuses in 8 Locations
• Seneca has more than 17,800 students with over 2,000 international students from 75 countries
• The largest number of full-time staff - 22 in total, dedicated solely to work for Seneca International students
• Seneca has a worldwide Network of Partnering Universities, numbering over 50, offering future academic opportunities within Canada and around the world

New Career Opportunity for students in Pharmaceutical Regulatory Affairs & Quality Control (RAQC)

Students who are looking for a career in the following specialized areas should opt for this course:

• Quality Control Operations
• Quality Assurance Management
• Pharmaceutical Regulatory Affairs
• Preparing and filing ANDA of Pharmaceuticals
• Quality Assurance Investigator
• Biotechnology
• Clinical Research

Advantages

On completion of this program students will be awarded two certificates, viz.:

1. Postgraduate Certificate from SPTM &
2. Ontario College Graduate Certificate from Seneca College, Canada

As a Pharmaceutical Regulatory Affairs Professional they can:

• Collect, collate and evaluate scientific data
• Present registration documents to regulatory agencies in India & the rest of the World
• Follow through all regulations to bring the product to market

A Quality Assurance Professional:

• Maintains and controls master documents
• Conducts audits and investigations
• Assists in the preparation of quality trend report

Placement assistance will be provided for graduating students
Our M.Pharm students work in collaboration with industries like Novartis, Wokhardt, Cadilla, Sandoz, Glenmark, Lupin, Nicholas Piramal, Serum Institute, IPCA, Rubicon and others

Program Overview & Fee Details

This program intends to provide students with a basic understanding of the areas of Pharmaceutical Regulatory Affairs & Quality Operations. They will be trained to handle -
Responsibilities involving drug or medical device submissions and Quality assurance functions and roles.

The issues of regulatory compliance in Canada and in other parts of the World will be dealt with.

The duration of the programme will be of one year consisting of three Semesters of 4 months each.

Semester I - Rs. 2,50,000. + Canadian Dollars (CAD) 647/- for online training program at SPTM Mumbai
Semester II - CAD 5400/- + CAD 1000/ p.m. for lodging and boarding at Seneca College, Toronto
Semester III - In Pharmaceutical or Pharmaceutical related industry in India. Fees Rs. 50,000/-

On completion of this course, students will be qualified for positions in the Pharmaceutical Industry with capability to handle Pharmaceutical Regulatory Affair

Important Dates

Admission Test Details

• The application form along with this handout and prospectus will be issued in the University office between 10.00 am and 6.00 pm on all working days. The last date for receipt of application, including postal receipts, is as per the date given above. No form will be accepted after the date given on the cover page.  
• Eligible candidates who fulfill the eligibility criteria and submit the application form within the due date will be called for the test. The candidate should check that he/she is eligible as per conditions regarding qualification stated in the Prospectus.You are required to download the call letter from our website www.nmims.edu No separate call letter will be mailed or posted
• If at any stage, it is found that a candidate does not satisfy the eligibility criteria or the information furnished by him/ her in the application form is incorrect, his/her application for the admission to the course, even if selected, will stand cancelled. Candidates appearing for the admission test will do so at their own risk of eventually forfeiting their admission for want of meeting the eligibility criteria.
• Canvassing in any form will disqualify the candidate
• All matters of dispute will be subject to the legal jurisdiction of Mumbai only. 
• The Admission Test and Personal Interview will be conducted only at Mumbai Centre and venue will be communicated to you in the call letter.
• The admission Test would be an objective type multiple choice test (there will be no descriptive types of questions)
• The admission test will comprise objective type questions based on English Language

Course Structure

CERTIFICATE AT SPTM – NMIMS UNIVERSITY, MUMBAI

Course Descriptions

Semester I   
Introduction to Pharmaceutical Regulatory Affairs (PRA700)
This subject describes the role of the Regulatory Affairs department in a pharmaceutical firm and focuses on the “submission process”.  The regulatory requirements at the various stages in a drug product’s development from inception through CTA’S (Clinical Trial Applications) and NDS (New Drug Submission) applications to issuance of the NOC (Notice of Compliance) will be examined.  Students will become familiar with the Food and Drugs Act and GMPs upon completion of this course.  Online taught via Seneca SBSAC.

Introduction to Quality Assurance (PQA711)
This subject focuses on the concept of Quality Assurance and the planning and contribution of the Quality Assurance Team in an organization.  Topics covered include QA/QC theory; documentation for GMPs; SOP theory, writing & reviewing; Auditing theory; Process deviations and SPC/SQC; Complaint handling and Product recall theory and; detailed training on GLPs, GMPs and the ISO Quality Standards.

The students will gain significant “hands-on” experience in document reviewing and SOP writing/reviewing.  The course also includes a significant amount of case study work in process deviation and audit investigations.  These skills are intentionally built into the program to provide students with meaningful QA skills that can be applied to their Co-op placement activities without a large training investment on behalf of the company who accepts them.

Technical Writing and Communication I ( TWC 713)
TWC713 is a post-diploma technical writing course designed to expose students to different types and techniques of technical writing for the purpose of writing SOPs and other documentation in the Pharmaceutical field and in the areas of Regulatory Affairs and Quality Assurance.  Audience analysis determines information needs and reader requirements to ensure understanding and to avoid costly mistakes.  Problem-solving and interpersonal skills as well as different correspondence methods and the required language prepare students to interact with the varying levels of personnel and regulatory authorities.  Techniques in research and oral presentation help the process of requesting and clarifying technical information.  All technical content requires clear and appropriate language, careful organization, suitable format, and effective design to ensure readability.

Product Formulation and Manufacturing (PFM 714)
After completing the course, students will have an understanding of the following:
The cGMP’s, how they came into being and their impact on Formulation and Manufacturing, including the importance of accurate documentation and validation of all processes.
Pharmaceutical mixing – mixers, excipients and the principles of how products are mixed to provide good flowing granulations

Principles of Encapsulation, Tableting and Tablet Coating – how improper design of tooling and use of equipment can negatively impact on the production and elegance of the finished product.

USP water, its preparation and the regulations and validation required for its use as an ingredient in the manufacture of Pharmaceuticals.
Solution, Ointment, Cream preparation and packaging as well as new novel drug delivery systems – Transdermal patches, aerosols, and sub-cutaneous implants will be discussed.
Students will have the opportunity to propose formulations for products and will learn how to troubleshoot problem products using the knowledge they have gained.

 Biotechnology and Biopharmaceuticals (PBB 814)
The purpose of this course is to give the students an introduction to the history, processes and development and submission of biopharmaceuticals and how they differ from traditional pharmaceuticals.  Individual projects will be completed with a product applicable to this market.

Semester II
Regulatory Affairs II (PRA 800)
This course will focus on the preparation of a drug submission.  The student will compile the necessary information and complete the necessary Application Forms for a New Drug Submission  (NDS).  The submission will be presented to the class with possible deficiencies identified and possible suggestions for dealing with expected deficiency letters.  The course will also be an opportunity for guest speakers from various related occupations in industry to expose the students to current events in the area of Regulatory Affairs.
Quality Assurance II (PQA 811)
This course describes the role and responsibilities of Quality Assurance department in a pharmaceutical company.  It focuses on:

1. the design of a proper quality control/assurance system to ensure the manufacturing of safe products and also to satisfy regulatory authorities.  All systems, from cleaning to component testing, from product assay to product release are geared to provide the manufacturer documented quality checkpoints on the product;
2. management of the quality assurance systems to provide sufficient and adequate records on all testing, distribution and all other procedures that must be in place.

Clinical research (PCR 901)
This course is aimed to introduce the student to some basic concepts in clinical research.  Students will learn how clinical research fits into the overall scheme of drug development and the multitude of factors involved in creating databases sufficient for acceptable New Drug Submissions.  The process of planning, developing, conducting and evaluating results of a clinical trial will be discussed.  The ever- changing climate of globalisation and increasing focus on ethical and human rights issues will be addressed.  Hands-on exercises will familiarise the student with some day-to-day activities typically practiced by entry-level clinical research.

Pharmacoeconomics (PEC715)
This course will provide students with the necessary information regarding pharmacoeconomic investigations.  The techniques used in pharmacoeconomic evaluation will be examined.  The application of the assessment of health benefits relative to drug costs in the determination of clinical cost-effectiveness will be studied.  Techniques for reporting pharmacoeconomic data and critical appraisal of the pharmacoeconomic literature will also be reviewed.

International Regulatory Affairs and Harmonization (IRA815)
This course provides the students with a review of the functions and purposes of international harmonization.  In addition pharmaceutical regulations in European countries, Japan and USA will be examined.  Specification criteria and tests with drug substances and drug products will be compared.  Guidelines for particular tests will be examined for limits and methods.

Program Eligibility

1. Applicants must have completed B.Pharm./ M.Pharm

Or

2. B.Sc/ M.Sc degree with Chemistry or Biology as a major subject.

TOEFL / IELTS is a must and has to be completed before the commencement of the second Semester of the programme. The details of the required scores are as follows

Selection Process

Step 1 (At the time of applying for the course)

• The Application Form will be available at NMIMS, Mumbai on payment of Rs. 950/- in cash & from NMIMS by post/ courier by enclosing a Demand Draft of Rs.1050/- (non – refundable, inclusive of courier charges) favoring SVKM’s NMIMS payable at Mumbai with a self addresses cloth bound envelope of size 10 “ X 13 “
• All eligible candidates should complete the application form, attach all relevant academic transcripts, valid English proficiency test (as described above), questionnaire and/ or Applicant Profile that will be assessed for content, writing skills, writing effectiveness and style.
• Applicant selection will be based on the assessment of the above assignments, academic credentials and English proficiency.
• The selection process consists of a two steps consisting of an Entrance Test conducted by Seneca and a Personal Interview conducted by SPTM.
• Qualified applicants will receive a conditional letter of acceptance from Seneca College.

Step 2 (After completing the first semester programme in Mumbai)

Qualified applicants on receiving a conditional letter of acceptance from Seneca College, will have to secure a valid Canadian Visitor Visa from the Canadian Embassy in India, (AFTER COMPLETING ACADEMIC CERTIFICATE at SCHOOL OF PHARMACY TECHNOLOGY AND MANGEMENT TECHNOLOGY, NMMIMS , MUMBAI)  for being allowed to travel to Toronto, Canada, and attend the 4 month Academic Semester II courses at Seneca College, necessary for the completion of the program.

Faculty & Course Material

• The course material will be provided by Seneca College
• The faculty teaching core subjects have several years' of industrial experience in the area of Quality Control, Quality Assurance and Pharmaceutical Regulatory Affairs

Course Advisory Board

• Dr. R S Gaud, Dean (Pharm Sciences), SPTM, Mumbai
• Dr. Anil Thaker, Professor (Pharm Chem.)
• Dr. Avijit Mazumder, Professor (Clinical Pharmacy)
• Dr. (Smt). Bala Krishnamoorthy, Professor & HOD Business Policy
• Mr. Vijay Kshirsagar, Executive VP, Co-operate Quality Assurance - Regulatory Affairs, Unichem Laboratories Ltd.
• Mr. K. S. Babu, Sr. GM, Corporate Regulatory Affairs, Watson

For more details about the course, please contact

Dr. Anil Thaker, Professor (Pharm Chem.)
anil_thaker@nmims.edu, anilthaker@hotmail.com
Dr. Avijit Mazumder, Professor (Clinical Pharmacy)
amazumder@nmims.edu, avijitmazum@yahoo.com