TypeOnline Course
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Price$390 / Rs. 19500
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Admission Process

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Introduction

Features

Duration

Eligibility

Course Title: KPE’s Certificate Program in European Drug Regulatory Affairs

Course Objective: The objective of this course is to impart knowledge and practical understanding about the Drug Regulatory Affairs and approval process in Europe.

This online course utilizes interactive learning tools to guide each participant through to understand of the EU regulatory structure and ensure that your submissions meet the standards required by the regulators. The course will focus on understanding the European legal & regulatory environment; the registration procedures that are available, and the structure of the registration dossier. The course will adopt a practical and interactive approach that will enable you to apply what you have learned to your daily work.the steps of approval process in details. The course is designed to challenge students to apply what they have learned through the use of interactive exercises, reflection questions, expert live chat and a final assessment at the end of the course.

EASTERN_EUROPE_MAP

The course can be completed at any pace, allowing the user to stop and start at their leisure.

Who should attend?

  • Regulatory Affairs professionals seeking to improve their skills in the regulatory environment
  • Those moving into regulatory affairs from other areas within a pharmaceutical company (Pharmacists, Clinical Trials, Marketing and others)
  • Anyone wishing to update their knowledge on European regulatory affairs
  • Regulatory Affairs, Registration and Documentation assistants/officers/managers

 

1. Orientation to practical understanding European Drug Regulatory process.

2. Simulation to real life Strategic planning in European market

3. Access to industry case studies.

4. Attend Live Lectures of all different chapters / study content.

1 Month

B.Pharma/D.Pharma/ B.Sc/ Any graduates or those who are in 3rd / final year of those courses, who want to make career in pharmaceutical marketing can pursue the course.

Section 1EU Regulation
Lecture 1Introduction to EU Regulation
Lecture 2Orientation to European Countries and National Regulatory Bodies
Lecture 3Overview of EU Regulation 
Lecture 4EMEA Procedures
Lecture 5Summary of Product Characteristics 
Lecture 6Compassionate Use
Lecture 7MHRA - UK Regulation 
Lecture 8The 'sunset clause' for marketing authorisations of pharmaceuticals
Lecture 9EU Orphan Medicinal Products Regulation
Lecture 10Data exclusivity for pharmaceuticals in Europe
Lecture 11Patent Vs. Exclusivity
Lecture 12Accelerated assessment by EMEA
Lecture 13Conditional marketing authorisation
Lecture 14Master Data Maintenance by EMEA
Lecture 15Pre-authorisation GMP Inspection
Section 2Clinical Trials
Lecture 16Clinical Trials Terminologies 
Lecture 17Clinical Trial Protocol Writing
Lecture 18Ethics in Clinical Research
Lecture 19Informed Consent
Lecture 20Clinical Data Publications
Lecture 21Clinical Trial Failure
Section 3Drug Dossier Preparation and Submission
Lecture 22Detailed understanding of Drug Dossier
Lecture 23Advance Practical Training on Dossier Preparation
Lecture 24CMC Dossier & Compliance Management
Lecture 25Modules on Stability Study : Stability Study - Fundamental Understanding | Interchangebility | Reports | API & FPP Stability Study
Lecture 26Review Test on Stability Testing 
Lecture 27Stability Testing of API 
Lecture 28Importance of effective dossier management
Lecture 29Review Test on Stability Testing 
Lecture 30Certificate of Analysis
Lecture 31Importance of effective dossier management
Lecture 32Key Consideration for Drug Master File Preparation and Submission 
Lecture 33Practical Understanding on Drug Master File Preparation and Submission
Lecture 34Site Master File - Detailed Understanding 
Lecture 35DMF Completeness Assessment
Lecture 36Drug Master File - Global Perspective [Across Different Regions]
Section 4Pharmacovigilance Program
Lecture 37ADR Monitoring
Lecture 38Why Pharmacovigilance Process
Lecture 39PSUR : Detailed Understanding
Lecture 40Risk Management
Lecture 41PV Program Implementation in EU
Section 5Recent Update : European DRA
Section 6Final Examination