merger merger

Welcome to your new course portal!

On October 15th, moved to - which means you can now find all your favourite courses right here. Don't worry - you can still do all the things that you could do before.

All you need to do is search.

Show as: Mobile

Regulatory Affairs Risk Management

Course summary
2 days
Professional Training

Course description

Regulatory Affairs Risk Management

Assessing and controlling risk is essential throughout the product life cycle of a drug, from research and clinical testing to manufacturing and distribution. Organisations must demonstrate to the competent authority that a documented plan is in place to identify, measure, control and monitor the various risks that exist.

Through case studies and examples you will gain a detailed view of risk from a regulatory perspective by examining simple risk assessment techniques and mitigation methods for specific risks including product recalls. Once completed you will better understand risk from the authorities point of view, enabling you to be better prepared for questions from global regulators. It will allow you to create robust risk management reports with advanced strategies for a variety of products. 

Suitability - Who should attend?

This course has been specifically designed to address the needs of:

  • Regulatory Affairs Managers/ Officers/ Assistants
  • Compliance Managers
  • Documentation Managers
  • Product Registration Personnel
  • Project Managers in Regulatory Affairs
  • Qualified Persons
  • Senior level managers who need an overview

Training Course Content

What will you learn?

  • Introduction on Pharmaceutical Risk Management
  • Identifying and understanding the areas of Pharmaceutical Risk Management
  • Road map to Risk Management Report
  • Company Preparation of Risk Assessment & Regulator Communication and Control
  • Case study: Risk Assessment, Control and communication
  • The function and Objective of the Quality Risk Assessment to authorities
  • Post Marketing Product Risk Management

Why choose PTI

On average, delegates of their online academies said: 

Quality of content:


85% had applied content during the course to their role

Delivery rating:


About provider

PTI - Pharmaceutical Training International

PTI - Pharmaceutical Training International - Training for the Pharma Industry

PTI is the global leader in professional education for the pharmaceutical industry, delivering a broad course portfolio that covers the industry spectrum: R&D, Clinical Development, Generics, Bio-pharmaceuticals, fine Chemicals, Agro-chemicals, Medical Devices, Animal Health, Manufacturing and Regulations. PTI's open courses,...

Read more and show all courses with this provider

Request info

Fill out your details to find out more about Regulatory Affairs Risk Management.

  Contact the provider

  Get more information

  Register your interest

Contact info



 Show phone number

Request Information

Find out more about this Regulatory Affairs Risk Management course - simply fill out your details:


There are no reviews available yet.

U.K. L&D Report: 2019 - Benchmark Your Workplace Learning Strategy

Are you curious about the L&D strategies of some of the U.K.'s top companies?

Find out what they're up to in's second annual U.K. L&D Report!


Learn more

Similar Courses