Advanced Postgraduate Diploma in Clinical Research & Regulatory Affairs
Course
Online
*Indicative price
Original amount in EUR:
890 €
Description
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Type
Course
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Methodology
Online
-
Duration
24 Months
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Start date
Different dates available
Clinical research is a rapidly progressing, essential field of medical science that deals with the evaluation of new medicines and therapies with an ethical approach. Developing these new medicines is very challenging considering the inter-individual, inter-racial and cultural diversities that we possess as human beings.
Advancement towards the idea of developing personalized treatments is giving a new dimension to the research and development efforts of the global drug development industry.
Fundamental to clinical research is the domain of regulatory affairs which forms a network of standardized laws, regulations and guidelines creating an equilibrium between facilitation of innovation and safety of subjects enrolled in clinical trials.
In the present global clinical research landscape, regulatory affairs professionals lead multinational assignments and make sure that clinical trials are performed in compliance to the applicable regulatory requirements of the sponsor’s nation as well as the international locations where the clinical trial is being conducted.
At JLI we strive to develop clinical research and regulatory affairs professionals who are equipped with the most relevant and up-to-date knowledge and skills. This Advanced Clinical Research and Regulatory Affairs training program is practically driven and centered on the tasks expected of a regulatory affairs professional in the clinical research industry. In this Regulatory Affairs training you are provided with the understanding of the global regulatory structure and acquire skills needed for regulatory strategic planning throughout the product lifecycle.
Facilities
Location
Start date
Start date
Reviews
-
Very good course.
← | →
Course rating
Recommended
Centre rating
Vitor Costa
This centre's achievements
All courses are up to date
The average rating is higher than 3.7
More than 50 reviews in the last 12 months
This centre has featured on Emagister for 3 years
Subjects
- Medical1
1 students say they acquired this skill
- Industry
11 students say they acquired this skill
- Global
11 students say they acquired this skill
- Compliance
11 students say they acquired this skill
- Planning
- Strategic Planning
- Clinical Research
11 students say they acquired this skill
- Clinical Trial
11 students say they acquired this skill
- Medical training
- Regulations
11 students say they acquired this skill
- Pharmaceutical Medicine
11 students say they acquired this skill
- Therapeutic AREAS
11 students say they acquired this skill
- STUDY START-UP
Course programme
Program StructureMODULE 01: GENERAL INTRODUCTION
MODULE 02: EPIDEMIOLOGY & EVIDENCE BASED MEDICINE
MODULE 03: PHARMACEUTICAL MEDICINE
MODULE 04: THERAPEUTIC AREAS
MODULE 05: ETHICS IN CLINICAL RESEARCH
MODULE 06: ROLES AND RESPONSIBILITIES
MODULE 07: CLINICAL TRIAL PREPARATION
MODULE 08: ESSENTIAL DOCUMENTS AND REGULATORY SUBMISSION
MODULE 09: STUDY START-UP
MODULE 10: CLINICAL TRIALS MONITORING
MODULE 11: COMPLIANCE AND AUDITS
MODULE 12: DATA MANAGEMENT AND BIOSTATISTICS
MODULE 13: REGULATORY AFFAIRS IN CLINICAL RESEARCH
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
MODULE 18: INTRODUCTION TO JUDICIAL SYSTEM IN INDIA, D&C ACT
MODULE 19: SCHEDULE Y
MODULE 20: INDIAN REGULATIONS GOVERNING CLINICAL TRIALS
MODULE 21: REGULATORY REGIME – FDA, EMA, JAPAN, SINGAPORE
MODULE 22: SAFETY TOPICS RELATED TO PRE-CLINICAL & CLINICAL STUDIES
MODULE 23: COMMON TECHNICAL DOCUMENT, IND & NDA REQUIREMENTS
MODULE 24: CMC INFORMATION & GHTF OVERVIEW
MODULE 25: MEDICAL DEVICES, VETERINARY PRODUCTS & BIOSIMILARS
MODULE 26: BIOPHARMACEUTICAL INDIAN REGULATIONS AND REGULATORY STRATEGIC PLANNINGAdvanced Postgraduate Diploma in Clinical Research & Regulatory Affairs
£ 762.22 VAT exempt*Indicative price
Original amount in EUR:
890 €
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