Showing 28-30 of 30 results
Pharmacovigilance Training – Self Learning
The Course modules are 1: Introduction to Pharmacovigilance ⦁ Definition and scope of pharmacovigilance (PV) ⦁ History and evolution of PV ⦁ Objectives and importance in healthcare and drug safety ⦁ Key stakeholders: regulatory authorities, MAHs, CROs, HCPs 2: Regulatory Framework and Guidelines ⦁ International and national PV regulations ⦁…
Pharmacovigilance Training Course
The Syllabus covers 1: Introduction to Pharmacovigilance ⦁ Definition and scope of pharmacovigilance (PV) ⦁ History and evolution of PV ⦁ Objectives and importance in healthcare and drug safety ⦁ Key stakeholders: regulatory authorities, MAHs, CROs, HCPs 2: Regulatory Framework and Guidelines ⦁ International and national PV regulations ⦁ Key…
Regulatory Affairs Training Course
The Training Modules are ⦁ Introduction to Regulatory Affairs ⦁ Overview of the Regulatory Environment ⦁ Importance and Role of Regulatory Affairs in Pharma and Biotech ⦁ Regulatory Bodies: FDA (USA), EMA (Europe), CDSCO (India), TGA (Australia), etc. ⦁ Drug Development and Approval Process ⦁ Preclinical and Clinical Trial Phases…
