Understand the requirements for designing the stability study, performing the stability testing, and finally preparing the stability documentation.
Partnered with life science experts and The Danish Medicines Agency, we cover everything from initial development to ongoing stability, ensuring you meet international guidelines.
Stability studies are a critical aspect of the pharmaceutical industry and involve the evaluation of how the quality of a drug or pharmaceutical product changes over time under various conditions. The purpose of stability studies is to establish the shelf life and storage conditions for a product, ensuring its safety, efficacy, and quality throughout its intended duration of use.
Stability documentation is a regulatory requirement when applying for approval of drug substances and drug products and for certain post approval changes.
Inadequate stability documentation can cause delays in the approval phase. Worst case is rejection of your application, or you can end up with a shorter shelf life than planned, inappropriate for suitable logistic for your drug product.
After the course you
• Understand the requirements for designing stability studies and performing stability testing for pharmaceutical products. This includes evaluating how the quality of a drug or product changes over time under various conditions.
• Can establish appropriate shelf life and storage conditions for pharmaceutical products, ensuring their safety, efficacy, and quality throughout their intended duration of use.
• Are updated with the current international guidelines, such as those from ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use) and EU, that are relevant to stability studies and documentation.
• Learn hands-on experience in designing stability studies and interpreting relevant guidelines from life science experts.
We have teamed up with experts from life science and The Danish Medicines Agency in this intensive 3-day course. We go through stability testing and documentation from development to ongoing stability. When working with stability documentation you need to know the relevant requirements and guidelines for stability studies. This course covers current international guidelines from e.g. ICH and EU.
The course consists of presentations from experts and the authorities, together with group work and cases in small groups. This facilitates your hands-on experience in designing stability studies from a high-level perspective and that you will get practical experience in interpretation of the relevant guidelines.
The course language is English
At the course you will meet:
Abderrahman “Abdi” Bojazar, Area specialist, Novo Nordisk A/S
Mikkel Pind, GDP & Anti-Counterfeit Specialist, H. Lundbeck A/S
Carsten Worsøe, Principal Scientist, Novo Nordisk A/S
Ditte Hougaard Vestergaard, QA Manager, Ascendis Pharma A/S
Helle Mulvad, Quality Assessor, Danish Medicines Agency
Masood Hosseini, Area Specialist, Novo Nordisk A/S
Peter Thyregod, Principal CMC Statistician, Ascendis Pharma A/S
Rikke Stavnsbjerg, Manager QC Support, ALK-Abelló
Sanna Vinding Jönsson, Principal scientist, LEO Pharma A/S
Sandra Auguste-Bowler, Principal Regulatory Specialist, Novo Nordisk A/S
Cecilie Møller Kristiansen, Quality Assessor, Lægemiddelstyrelsen
Monica Pulis, Principal Professional, LEO Pharma A/S
