ONLINE COURSES

Advanced Post-Graduate Diploma in Clinical Research
and Regulatory Affairs
Online Training in Clinical Research & Regulatory Affairs | Regulatory Affairs Training

Online Training in Clinical Research & Regulatory Affairs | Pharmaceutical Regulatory Affairs Training

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 INTRODUCTION TO THE JUDICIAL SYSTEM IN INDIA
MODULE 2 DRUGS AND COSMETIC ACT AND RULES
MODULE 3 SCHEDULE Y
MODULE 4 INDIAN REGULATIONS GOVERNING CLINICAL TRIALS
MODULE 5 REGULATORY REGIME IN US
MODULE 6 EUROPEAN MEDICINES AGENCY (EMEA)
MODULE 7 REGULATIONS IN JAPAN
MODULE 8 IN-VITRO & IN-VIVO PRE-CLINICAL STUDIES
MODULE 9 EFFICACY TOPICS RELATED TO CLINICAL STUDIES
MODULE 10 COMMON TECHNICAL DOCUMENT (CTD)
MODULE 11 IND & NDA REQUIREMENTS
MODULE 12 CMC INFORMATION
MODULE 13 OVERVIEW OF GHTF
MODULE 14 REGULATORY PROCESSES FOR MEDICAL DEVICES AND VETERINARY PRODUCTS
MODULE 15 BIOSIMILARS EMEA GUIDANCE AND REGULATIONS
MODULE 16 BIOPHARMACEUTICAL INDIAN REGULATIONS AND GUIDELINES
MODULE 17 REGULATORY STRATEGIC PLANNING, INTERFACING & 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 6 - 8 months (Maximum duration 24 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 all JLI courses is very reasonable. Please use our Course Fee Calculator below to know the course fee applicable to you.

If you are not sure about the fee applicable to you for Advanced Post-Graduate Diploma in Clinical Research and Regulatory Affairs for the academic year 2012-13 please send an email to admissions@jli.edu.in or chat with our online counsellor.

For more details about the admission procedure please 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.

According to a business report by RNCOS it is stated that the Indian clinical trials market is set to grow at a CAGR of almost 36% registering a revenue worth of US $546 million in 2011.

Advanced Post-Graduate Diploma in Clinical Research and Regulatory AffairsOnline Training in Clinical Research & Regulatory Affairs | Regulatory Affairs Training

Advanced Post-Graduate Diploma in Clinical Research
and Regulatory Affairs
Online Training in Clinical Research & Regulatory Affairs | Regulatory Affairs Training