Our PG Diploma in Clinical Research & Regulatory Affairs typically focuses on providing specialized knowledge and skills related to conducting clinical trials and managing clinical research projects.
An interactive program providing distance and classroom training for the clinical research professional, begins with the history of legislation and regulations that govern clinical research and an overview of drug, biologic, and device development. Course participants develop a thorough knowledge base of Good Clinical Practices and International Conference of Harmonization guidelines (E6, E2A), gaining a solid understanding of clinical trial development and management.
These programs are designed for the professional who wants to transition into a Clinical Research Associate/ Clinical Research Investigator/ Study Coordinator/ Clinical Data Manager/ Biostatistician/ Regulatory Affairs Managers/ Clinical Trials Auditor/Clinical Project Manager/Clinical Research Manager/ Business Development Manager/ Drug Safety Associate/Medical Writer/Lab record analyst/ Trial master file specialist or enter the clinical research industry. It offers a comprehensive Education and “Hands-On” Training of the clinical research process, the FDA regulations, GCP (Good Clinical Practice) and the International Conference of Harmonization (ICH) guidelines. Over 20,000 people have successfully completed our program.
Indian Institute of clinical research & Management has expanded to provide individuals with additional training options via class room / distance/Online learning system providing flexible and affordable clinical research training via comprehensive training programs, education modules and interactive Webinars. On-site training is the part of clinical research program.
Over the year 25, 00,000 jobs are available in this field
Eligibility PG diploma in Clinical Research & Management
- Life Science and Health Care Graduates or Diploma in any Discipline
- B.Sc/ M.Sc, Biotechnology, Microbiology, Genetics, Biochemistry, DMLT, MLT
- M.B.B.S.M.D., MS.
- B.D.S., M.D.S., B.V.SC, M.V.Sc, B.PTh, M.PTh, OPTh, ANM, GNM.
- B.H.M.S., B.A.M.S, B.U.M.S, B.Sc Nursing
- B. Pharma, M. Pharma, D.Pharma
- For SAS: B.C.A, B.com, BCCA, B.E. Any Other Graduates.
- Highly interested participate in the final year can also apply.
Highlights of Advanced PG Diploma in Clinical Research & Regulatory Affairs
- Clinical Research Methodology: Covers the fundamentals of designing, conducting, and analysing clinical trials, including ethical considerations and regulatory requirements.
- Clinical Trial Management: Focuses on project management aspects specific to clinical trials, such as protocol development, patient recruitment, data collection, and monitoring.
- Regulatory Affairs: Addresses the regulatory framework governing clinical research, including understanding guidelines from authorities like the FDA (in the US) or EMA (in Europe).
- Quality Assurance in Clinical Research: Emphasizes ensuring the integrity and reliability of data through quality assurance practices and compliance with Good Clinical Practice (GCP) guidelines.
- Drug Development Process: Provides insights into the stages of drug development from pre-clinical research to post-marketing surveillance.
- Biostatistics and Data Management: Covers statistical methods used in clinical research, as well as data management techniques to ensure accurate and reliable data collection and analysis.
- Health Economics and Market Access: Explores the economic aspects of healthcare interventions and strategies for market access of new therapies.
- Ethical and Legal Issues: Discusses ethical dilemmas in clinical research, patient rights, informed consent, and legal considerations.
Career Opportunities
- Clinical Research Associate (CRA): Monitors clinical trials and ensures compliance with protocols and regulatory requirements.
- Clinical Project Manager: Oversees the planning, execution, and budgeting of clinical trials.
- Regulatory Affairs Specialist: Ensures adherence to regulatory guidelines and prepares submissions for regulatory approvals.
- Data Manager: Manages clinical trial data and ensures its accuracy and integrity.
- Medical Writer: Prepares documents such as study protocols, clinical study reports, and regulatory submissions.
- Drug safety Associate: Drug Safety Associate is to monitor the safety of drugs and medical devices once they are on the market and ensure that they are being used safely.
- Data Analyst: Clinical data analyst involves managing information and staying aware of any noteworthy data trends
- SAS Analyst: As a SAS analyst, responsibilities are to collect and interpret data and to use SAS software tools to draw conclusions from data.
Skills Developed
- Project Management: Ability to plan, execute, and manage clinical trials within timelines and budget constraints.
- Regulatory Knowledge: Understanding of regulatory guidelines and compliance requirements.
- Communication Skills: Effectively communicate findings and requirements to various stakeholders.
- Critical Thinking: Analyse data and make informed decisions based on scientific evidence.
Conclusion
A PG Diploma in Clinical Research & Management equips you with specialized skills in clinical research methodology, regulatory affairs, and project management, preparing you for various roles within the pharmaceutical, biotechnology, and healthcare industries. It’s a valuable credential for those looking to enter or advance in the field of clinical research, Clinical Data Management, Pharmacovigilance & SAS.
