Course - Post Gradulate Diploma in Clinical Research And Pharmacovigilance

COURSES

JLI students get the opportunity of reading, listening to lectures, additional reference readings, exercises and assignments, as many times as they may need during the course to attain maximum understanding of the subject. This is substantiated by a prompt query resolution support by well learned faculty from the industry. This kind of personalized approach takes away the constraints of distractions, missed classes, fatigue and sometimes-unbearable ennui seen in regular classrooms.

Advanced Post-Graduate Diploma in Clinical Research
and Pharmacovigilance

The pharmaceutical and biotech industry is revolutionizing in a manner where innovation and pharmacovigilance are not polarized. The business models are maturing to the next level of niche busters and towards a coexistence of novel and the age old blockbuster strategies.
Pharmacovigilance forms the backbone of the product life cycle due to a demand created by the need for new drugs and their regulation.
With the economic drift and emerging economies like India, China, Brazil and Russia, the pharmaceutical and biotech industry is shifting research and development towards these regions especially in the phases of clinical development.

A number of multinational companies like Pfizer, Novartis, Quintiles, GSK have set up pharmacovigilance centres in the major clinical research hubs worldwide, including India. In November 2004, the Indian ‘Central Drugs Standard Control Organization’ (CDSCO) launched the National Pharmacovigilance Course under the aegis of Directorate General of Health Services, Union Ministry of Health and Family Welfare.
Further, indigenous pharmaceutical and biotech companies in these regions are increasing their R&D efforts both for innovative molecules as well as the generic market. A market analysis conducted by Frost & Sullivan titled ‘World Pharmacovigilance Markets in Lifesciences’ finds that the pharmacovigilance market worldwide in 2008 was worth $1859.9 million and is estimated to reach $2252.2 million in 2015. This market report also stresses upon the evolving trend of major pharmaceutical companies to outsource/offshore their pharmacovigilance operations. There is a regular influx of this outsourcing activity in to the Indian market.
In the broader economic platform, a large number of clinical research management organizations have recently developed which include a range of full service CROs, early phase CROs, SMOs, companies with selective specialized services like data management and drug safety, clinical research consultancies, KPOs, etc
This has created a demand for skilled workforce in the clinical research industry as stressed in many business reports.

James Lind Institute is committed to developing emerging professionals for the clinical research industry who are equipped with the most relevant and latest knowledge and expertise.

The APGDCR-P course is an integrated course that will provide you with a systematic understanding of the core areas of the clinical research process and pharmacovigilance methodologies thus enhancing your skills and knowledge to the level expected of a Clinical Research and Pharmacovigilance Professional. Apart from clinical research management, this integrated course trains students to collate, analyze and archive adverse drug reaction data in order to make regulatory decisions regarding marketed drugs. Both these sectors of the industry are now creating large number of new job opportunities.

The APGDCR-P course curriculum is fully reviewed and endorsed by the Clinical Research Industry and the academia thus imparting students the edge that they require to make an entrance in the industry. It also empowers the professionals working in the clinical research industry with the skills and knowledge required to move to higher cadres of the management hierarchy.

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

PHARMACOVIGILANCE

MODULE 1 PRINCIPLES OF PHARMACOVIGILANCE
MODULE 2 PHARMACOVIGILANCE AND SELECTED SYSTEM ORGAN CLASSES
MODULE 3 PHARMACOVIGILANCE SYSTEMS
MODULE 4 GLOBAL PHARMACOVIGILANCE AND SAFETY STANDARDS
MODULE 5 PHARMACOVIGILANCE REGULATIONS AND GUIDELINES
MODULE 6 PHARMACOEPIDEMIOLOGY

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

Academic Support

Each student in the APGDCR-P 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

Our unique academic approach provides enrolled students with a tutoring advisor/mentor. The tutor is also a member of the "Students Success Team" who mentors students for all round professional development. Tutors form an invaluable resource for the students bringing them in an interface with the industry.