Pharmacovigilance
Medical Coding
Computer Aided Drug Design (CADD)
Computerized System Validation (CSV)
Regulatory Affairs
Introduction to Pharmaceutical Science
- Introduction to Pharmaceutical Labelling
- Introduction to GMP in Pharma Industry
- Introduction to European Medicines Regulation - Free
- Introduction to Regulatory Affairs
- Introduction to Pharmacovigilance
- Introduction to Quality Management System
- Introduction to Medical Devices
- Introduction to Clinical Trials
- Introduction to Medical Writing
- Introduction to Medical Coding
- Introduction to Clinical Data Management
About Pharmacovigilance Courses
Pharmaceutical companies are tightly regulated, with stringent government regulations to safeguard public health. The top priority of the pharmaceutical industry is to create and market a Drug that satisfies regulatory criteria. Drug development, manufacturing, and marketing all have varying aims. It must ensure safe and effective pharmaceutical formulations get to consumers promptly and prevent ineffective/dangerous/hurtful medicines from reaching patients.
A drug regulatory authority must ensure the safety, efficacy, and quality of all pharmaceuticals sold in its nation. The main challenge for the regulatory expert is to make sure that medicines are produced according to local rules, which includes examining key aspects throughout drug product development.
The Entry Level Certification Course on Pharmacovigilance Course is for those who want to develop a foundation in pharmacovigilance and learn about the drug safety process. In comparison, the Pharmacovigilance Certification Course for Professionals is designed for those who want to deepen their knowledge and specialize in the field.
These courses will prepare you for a career in pharmacovigilance and help you develop the skills you need to excel in this field.”]
ENTRY LEVEL CERTIFICATION COURSE ON PHARMACOVIGILANCE Couse
Description
This pharmacovigilance course will provide a comprehensive overview of how to manage and report safety information according to the latest international guidelines. The topics include audits, expectations for risk-based inspections (RBI), compliance with drug safety regulations like product approval/licensing agreements from Europe Union countries or other regions where they exist; also providing an introduction to Product Safety Reviews – its purpose function(incorporating CIOMS III requirements) as well new changes brought about by 2nd revision ICH E2C standards that are applicable today’s industry practices making them essential skills every company needs!
Courses Outcomes
Upon finishing this course, you will be able to:
- Recognize the fundamentals and intricacies of pharmacovigilance and drug safety.
- Recognize the reporting database for pharmacovigilance (e.g., Signal Detection, Risk Assessment, and Evaluation)
- Demonstrate an understanding of PV Guidelines (ICH E2C, WHO, etc.) and their practical applications in the workplace.
- Understand risk management concepts, tools, and methods for identifying and assessing risks.
- Examine signal management for causation assessment using a critical approach.
- Improve your writing skills when it comes to producing PV reports.
Who Should Attend
This course is required for pharmacovigilance, regulatory affairs, and drug safety professionals. It’s also useful for those looking to enter the field of pharmacovigilance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers.
CERTIFICATION COURSE FOR PROFESSIONALS AND GRADUATES ON PHARMACOVIGILANCE
Description
This course is based on 21 CFR guidelines, designed to provide participants with an in-depth understanding of pharmacovigilance activities and how they are integrated into the drug development process. The topics covered include pharmacovigilance audits (RBI, PLA), risk management (REMS, CAPA, RMP, SMP), signal detection (AERS, VRMPT, RMP, SMP, SPE, PSR, etc), and product safety reviews (PSR, PSUR) based on GVP guidelines. In addition, you will also get a 30 hours hand on training on PvEdge software.
Pharmacovigilance Courses Outcomes
Upon finishing this course, you will be able to:
- Demonstrate an understanding of pharmacovigilance activities and their role in the drug development process.
- Understand how to conduct a pharmacovigilance audit.
- Understand how to manage risk in pharmacovigilance.
- Demonstrate an understanding of signal detection in pharmacovigilance.
- Demonstrate an understanding of product safety reviews in pharmacovigilance.
- Understand how to use PvEdge software for pharmacovigilance activities.
Who Should Attend
This course is required for pharmacovigilance, regulatory affairs, and drug safety professionals. It’s also useful for those looking to enter the field of pharmacovigilance. Students (B. Pharma/ M. Pharma/ B.Sc./M.Sc., MBBS / BDS), pharmaceutical and healthcare industry regulators, and academic research centers)