Study location	Online
Type	Advanced PG Diploma, e-learning
Nominal duration	12 months (60 ECTS)
Study language	English
Awards	APGDCR-RA (Advanced Postgraduate Diploma in Clinical Research & Regulatory Affairs)
Accreditation	Certified by Swiss EduQua via certificate no CH20/0771

Tuition fee	€2,200 one-time Payments can be made in full; or 2 equal installments (Half after applying and half within 2 months)

Entry qualification	Bachelor's degree (or equivalent / higher) A bachelor’s degree or equivalent preferably in any life sciences related domain. If you are not sure about your eligibility, please contact our admissions counselors.

Language requirements	English

More information	jliedu.ch

Overview

Mode of Learning: ONLINE
Duration: 12 Months (Self Paced)
Maximum Allowed Duration: 24 Months
Expected Effort: 10-15 hours/week

In this training course, you will understand the techniques of critical evaluation for risk/benefit analysis by assessing the economic, societal, regulatory and corporate requirements. You will also attain the expertise essential for performing in an advisory role as a regulatory affairs specialist for pre and post-marketing projects. Additionally, you will learn how to interface with the regulatory agencies and other key stakeholders for accomplishing regulatory compliance.

Programme structure

Module 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: Extended Regulatory Affairs

Career opportunities

This unique program will prepare you to explore clinical research job opportunities such as clinical research coordinator, clinical research associate, clinical trial manager as well as jobs that are specific to regulatory affairs such as Regulatory Affairs Executive / Associate / Manager etc.