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PROGRAM OVERVIEW
This program provides knowledge and insight into the most recent developments in the clinical research, drug development and pharmacovigilance in compliance with FDA and global regulations and guidelines. Students will learn Good Clinical Practices, regulatory framework of drug development, organization and management of studies conducted across multiple phases to assess the safety and effectiveness of medications, vaccines, and devices, as well as quality assurance concepts, and current pharmacovigilance methodologies, including Good Pharmacovigilance Practices (GVP).
Drug Development
Drug development is the process of bringing a new medicine to the market once a new drug candidate compound has been identified through the process of drug discovery. It includes pre-clinical research on animals, filing for regulatory status, such as via the FDA for an investigational new drug (IND) to initiate clinical trials on humans, and may include the step of obtaining regulatory approval with a new drug application (NDA) to market the drug.
Learn essential requirements for various documents submissions and their Common Technical Documentation (CTD/eCTD) format for each step of the drug licensing process
Clinical Research
Clinical research, and clinical trials, are
important steps in developing new medicines and are essential to the pharmaceutical industry and healthcare systems across the world.
Clinical researchers are responsible for ascertaining how safe and effective new drugs, biotechnological products, and medical devices are, and as such their role is
demanding with plenty of responsibility riding on it.
Gain practical skills in administration, management, and monitoring of clinical trials conducted across multiple phases and learn clinical data management, technical and scientific writing, and QA/QC concepts and basics of clinical trials design.
Pharmacovigilance
Pharmacovigilance primarily identifies the hazards related with pharmaceutical products and therefore aims in minimizing the risk of any harm that may come to patients. It also oversees inaccurate or incompleteness in medication leading to overdose or after a drug abuse.
Our training provides the basis in pharmacovigilance principles and operations. Learn advanced skills of pharmacovigilance writing, drug product’s life cycle and how to complete the associated pharmacovigilance documents, supported with a summary of the underpinning regulations, guidelines, and templates.
Admission Requirement:
-
BSc. (or equivalent) or
higher level of education.
Course Length
- 36 weeks
- JOB OPPORTUNITIES
- Clinical Research Coordinator
- Clinical Research Associate
- Clinical Data Coordinator
- Medical/Scientific Writer
- Regulatory Affairs Specialist
- Clinical Research
- QA&QC Specialist
- Pharmacovigilance Associate
- NETWORKING
We developed strong partnerships with industry-leading companies in pharmaceutical and clinical field. We work directly with these organizations to provide opportunities to our graduates.
- ONLINE E-LEARNING
Our online learning environment gives students the option to learn completely at their own pace, anywhere and at any time of the day. Learners will have access to our subject matter experts who are there to provide support and answer any subject related questions.
