This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area.
★★★★★ "Very good"
13 October 2023
Risk management is becoming increasingly important to drug and medical device development and ensuring compliance with regulatory expectations and during challenging times such as a pandemic. There are now numerous pharmaceutical guidelines covering risk management including ICH Q9, ICH GCP R2, drug and device risk based guidance during a pandemic, regulatory risk based approaches, and the recently finalised FDA Risk-based monitoring of Clinical Investigation questions and answers guidance.
This essential course will explain the importance of using risk management techniques in drug and device development to comply with the latest focus on inspection in this area. It will show you how risk management can improve the quality of your development projects and demonstrate the importance of using risk analysis and risk management techniques in the pharma, biopharma and medical device industries. You will learn how to identify, evaluate and implement specific risk-based techniques for risk management, including a quality management framework.
The course will enable you to develop quality risk management principles applicable to pharma, biopharma and device development, as well as to identify and share best practices for risk management tools and approaches.
This course is part of our Regulatory Affairs Training course collection, which features updates on the latest regulations to registration procedures and strategies.
Anyone who is needs to understand risk management working in the pharmaceutical and medical device industry. Particularly those needing to understand the regulatory expectations, associated guidance and be able to apply different tools and techniques in their role.
Dr Laura Brown is an independent pharmaceutical QA, management and training consultant and Senior Lecturer for the MSc in Clinical Research, School of Pharmacy, University of Cardiff. Laura has more than 20 years’ experience of quality assurance and managing international clinical trials including risk identification and management. She has worked for several leading companies including GSK, Hoechst Marion Roussel, Good Clinical Research Practices and Phoenix International and is an international expert on GCP and clinical trial requirements. Laura was chair of the Institute of Clinical Research GCP Forum for six years and writes regularly on clinical research regulatory requirements.
NEW higher discounts for multiple bookings - bring your colleagues to make your training budget go further:
Please contact us for pricing if you are interested in booking 5 or more delegates
13 October 2023
09:30-17:00 UK (London) (UTC+01)
10:30-18:00 Paris (UTC+02)
04:30-12:00 New York (UTC-04)
Course code 12375
Until 08 Sep
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* Early booking discounts may not be combined with other discounts or offers. As such, the discounts for 2nd/3rd/4th delegates are based on the full price.
Oct 14 2022
Arna Hrund Arnardottir
Senior Consultant RA, DADA Consultancy BV
Multiple colleagues? See above for details of our discounts for 2, 3, or 4 delegates. For more, talk to one of our training experts to discuss how to: