BioPharmaChem Skillnet

GXP – Introduction to Regulatory Affairs – 2 Day January 23 & 24 2023

GXP – Introduction to Regulatory Affairs – 2 Day January 23 & 24 2023

525.00 (member rate)

This course runs online on January 23 & 24 2023.

Date: 23/01/2023
Location: Online via GotoWebinar
Provider: BPC Skillnet
Time: 09.00 - 16.30
Duration: 2 days

In stock

Category:

Description

Day 1
Regulatory Introduction
 Ireland and the EU – Regulatory Structure
 Irish and EU Medicines Legislation
 Irish and EU Guidance
 Medicinal Products Regulation – Definitions and Terminology
 Regulatory documentation – Dos and Don'ts
Getting Started – Clinical Trials
 Clinical Trials and GCP
 Getting your Clinical Trial Approved – Introduction
 Clinical Trial Pharmacovigilance

Day 2
Getting Licensed and Staying Licensed
 The Common Technical Document
 Making a Medicinal Product Application – Application Types and Regulatory
Procedures
 Renewals
 Variations

Post-Marketing Pharmacovigilance
 Introduction to Post-marketing Pharmacovigilance
 PV Systems, Audits and Inspections
 PV Regulatory Requirements

BioPharmaChem Skillnet Training Course
GXP – Introduction to Regulatory Affairs – 2 Day January 23 & 24 2023
525.00 (member rate)