Quality Risk Management

How Has It Been Implemented?

21 November 2018 at 8:30-17:00

Practical Information:

- The agenda of the day is available here.

- Registration is available through this link.

- There is a limited number of rooms available at the AC Hotel Bella Sky Copenhagen, the ISPE Nordic rate is 1350 DKK per night. Book your group rate for ISPE Nordic before the 06th of November 2018.

The Event:

It has been now 13 years since the publication of ICH Q9. Since the finalization of ICH Q9 there has been a significant increase in expectations and effort from industry and regulators to encourage the use of a risk-based approach.

The vision for ICH Q9 was to develop a harmonized pharmaceutical quality system applicable across the life cycle of the product, emphasizing an integrated approach to risk management and science. This by stating the two primary principles of Quality Risk Management

  • The evaluation of the risk to quality should be based on scientific knowledge and the ultimately link to the protection of the patient.
  • The level of effort, form, formality and documentation of the quality risk management process should be commensurate with the level of risk.

This Conference focus on discussions around where we are now, and how we can work together towards a further harmonized view of terms, principles and application of QRM.

Questions that will be discussed:

  • Are medical products safer today than before 2005?
  • Has Quality Risk Management been implemented together with using science, or has risk assessment activities just escalated?
  • We still see mix-up, defective batched product contamination. So, what are the pitfalls in using Quality Risk Assessment and not complete Quality Risk Management?

During this conference, we want you to be inspired by the presentations and enjoy good discussions while enhancing your network.

Hear what the keynote speakers have to say about:

  1. The importance of using QRM to assure patient safety and product Quality
  2. The connection between ISPE Nordic to ISPE international and the importance of ISPE Nordic to the pharmaceutical industry.

Come join us at ISPE Nordic Annual Meeting 21.11.2018 in the beautiful city of Copenhagen.

To be held at:
Comwell Conference Center,
Center Blvd. 5,
2300 København, Danmark