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Hands-On Training for Small Molecules, Biologics and Medical Device to Harmonize Global Systems and Enhance Stability Programmes

June 19-21, 2018
  • London, United Kingdom

New Final Guidance Released!

On May 22nd FDA released a final guidance on Bioanalytical Method Validation. This guidance serves to inform the development of methods used to ensure the effectiveness for safety and effectiveness of drugs and biologic products. As stated in the documents, “Validating the analytical method ensures that the data are reliable by addressing certain key questions, including:

  • Does the method measure the intended analyte?
  • What is the variability associated with these measurements?
  • What is the range in measurements that provide reliable data?
  • How do sample collection, handling, and storage affect the reliability of the data from the bioanalytical method?”

Join us next month to discuss!

As the regulatory landscape shifts and drug approval processes continue to become more complex, now more than ever it is critical for life sciences companies to ensure sound stability testing standards to assess drug safety and efficacy. IVT Lab Week Europe’s Stability Testing is the industry’s leading forum for stability professionals to benchmark against thought leaders, share best practices and overcome key challenges within their current stability programs.

Running concurrently with IVT’s Analytical Procedures and Methods Validation conferences, this opportunity allows attendees to review core FDA and ICH guidance to breaking down the latest regulatory policies, including a brand new updated WHO draft guidance for API and finished drug stability testing. Join IVT to discover innovative approaches for developing, implementing and deploying risk- and science-based stability programs enterprise-wide.

Whether you are new to stability testing or a veteran stabilitarian, this event provides the ideal platform for scientists, chemists, quality control, laboratory and stability professionals.

Gain Insight on the Latest Updates
and Challenges, Including:

  • Mitigate data integrity risk in stability testing —
    Break down MHRA, WHO, FDA, PIC/s and EMA guidance
  • Statistical modeling and evaluation of stability
  • Apply risk assessment to stability functions
  • Investigate OOT and OOS in stability studies
  • Explore novel approaches in stability testing involving
    lean stability processes and outsourcing
  • Gain insight on best practices to handle stability chamber excursions
  • Navigate theory and practical design of forced degradation studies
  • Implement Quality-by-Design (QbD) to ensure expected and
    intended performance

Download the Lab Week Agenda at a Glance

Previous Attendee Acclaim:

Excellent mix of ‘state of the art’ stability information
for newcomers, and brand new approaches
for experienced stabilitarians.

Section Head, F. Hoffmann-La Roche Ltd.

Interesting to listen to and meet other professionals from the industry and learn their practices. It helps our lab
to improve our own practices.

Senior Stability Scientist, Allergan

Good learning experience about Stability and expected Industrial Standards for a newly starting person like me.

Development Chemist, Dechra Pharmaceuticals

Great mix of topics, attendees and speakers.

Stability Information Specialist, Nagano Science