A unique methodology utilized by JLI and only possible online is group problem solving. Students come to the “Online Campus Tutoring Center” with their problems, questions, and difficulties. They get answers from their fellow students, seniors and juniors. The process is mentored and moderated by the faculty. This forms a complete 360 degree learning environment.

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Advanced Post-Graduate Diploma in Clinical Research
and Regulatory Affairs

Clinical research is a highly dynamic and vital discipline addressing to the need of evaluating new treatments in an ethical manner. A recent recognition of diversity in inter-individual and interracial gene pools along with an age old cultural diversity makes it more challenging. Progress towards the concept of building personalized medicines is giving a new shape to the whole pharmaceutical research and development industry.

Central to this scientific discipline is the domain of regulatory affairs which forms a web of standardized laws and conventions striking a balance between facilitation of innovation and safety of clinical research subjects.

In today’s clinical research environment, regulatory affairs professionals spearhead the multinational projects and ensure that trials are conducted in accordance to the regulatory requirements of the sponsor’s country as well as the country hosting the study.

We at the James Lind Institute develop students interested in regulatory affairs into accomplished professionals abreast with the latest knowledge required. The APGDCR-RA course is practically oriented and based on the tasks expected of a regulatory affairs expert in the clinical research industry. Students enrolled for the APGDCR-RA course are provided with the knowledge of the worldwide regulatory framework and develop skills required for regulatory strategic planning throughout the product lifecycle. Students in this course learn the methods of critical evaluation for risk/benefit analysis by analyzing the economic, societal, regulatory and corporate demands. Students also gain the knowledge necessary for working in an advisory position as a regulatory affairs expert for pre and post marketing projects. Further students in this course are taught to interface with the regulatory authorities and clinical research stakeholders for facilitation of regulatory compliance.  


Course Structure

  • MODULE 1 GENERAL INTRODUCTION
  • MODULE 2 EPIDEMIOLOGY AND EVIDENCE BASED MEDICINE
  • MODULE 3 PHARMACEUTICAL MEDICINE
  • MODULE 4 THERAPEUTIC AREAS
  • MODULE 5 ETHICS IN CLINICAL RESEARCH
  • MODULE 6 ROLES AND RESPONSIBILITIES
  • MODULE 7 CLINICAL TRIAL PREPARATION
  • MODULE 8 ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
  • MODULE 9 STUDY START-UP
  • MODULE 10 CLINICAL TRIALS MONITORING
  • MODULE 11 REGULATORY AFFAIRS IN CLINICAL RESEARCH
  • MODULE 12 COMPLIANCE AND AUDITS
  • MODULE 13 DATA MANAGEMENT AND BIOSTATISTICS
  • MODULE 14 MEDICAL DEVICE TRIALS
  • MODULE 15 PROJECT AND VENDOR MANAGEMENT
  • MODULE 16 FINANCIAL MANAGEMENT OF CLINICAL TRIALS
  • MODULE 17 PERSONALITY DEVELOPMENT AND COMMUNICATION SKILLS

REGULATORY AFFAIRS
  • MODULE 1 REGULATORY STRATEGIC PLANNING
  • MODULE 2 PRE-MARKETING REGULATORY AFFAIRS
  • MODULE 3 POST-MARKETING REGULATORY AFFAIRS
  • MODULE 4 INTERFACING
  • MODULE 5 CORPORATE COMMUNICATIONS

The later part of the course would involve mock exercises concerned with a real-time role review of a Clinical Research Professional in different capacities.


Course duration

Self Paced 8 - 10 months

A student for the Advanced Post Graduate Diploma in Clinical Research & Regulatory Affairs (APGDCR-RA) is expected to study online for a minimum of fifteen hours per week.


Course Assessment

Course assessment involves online MCQs for each lecture, followed by assignments and numerous assessments by tutors in the “Online Campus Tutoring Centre” by the method of interactive discussion.


Eligibility Criteria

The minimum eligibility criteria for the course would include either of the following:

  • MBBS/BHMS/BAMS/BPT/MPT/BDS/BMLT/Bachelor in Naturopathy & Veterinary Science /MD/MS.

  • Graduate/Postgraduate degree in Pharmacy/ Pharmaceutical Sciences.

  • Graduate/Postgraduate degree in Life Sciences (Botany, Zoology, Biochemistry, Microbiology, Genetics, Biotechnology).

  • Graduate/Postgraduate degree in Chemistry/Biostatistics/ Bioinformatics.

  • Graduate or equivalent degree in Nursing/Allied Health.

  • Students in their final year of graduation for the above courses may also apply.


Fee Structure

Course fee for the Advanced Post Graduate Diploma in Clinical Research & Regulatory Affairs (APGDCR-RA) for 2010-2011 is INR 22,500.
For more details about admissions click here


Academic Support

Each student in the APGDCR-RA course is assigned a mentor throughout the course who will be a senior professional from the Industry. Students are in close contact with the “Student Success Team” during the course and thereafter as alumni. To know more about the “Student Success Team”, click here.