Ensuring the quality, safety, and efficacy of pharmaceuticals over time is crucial.
Pharmakon offers an intensive 3-day course that provides practical insights into the design, execution, and documentation of stability studies for those responsible in this field.
Your benefits:
⭐ Understand the requirements for designing and conducting stability studies in compliance with international guidelines such as ICH and EU.
⭐ Establish appropriate shelf life and storage conditions for pharmaceutical products to ensure their quality throughout their lifecycle.
⭐ Gain up-to-date knowledge of international guidelines relevant to stability studies and documentation.
⭐ Hands-on experience in designing stability studies and interpreting relevant guidelines from life science experts.
Course content:
📌 Stability in the development phase
📌 Photostability
📌 Bracketing & matrixing (ICH Q1D)
📌 Stability for Climatic Zone IV countries
📌 Temperature-controlled distribution
📌 Impurities and degradation products – requirements and analysis (ICH Q3A/Q3B)
📌 Specifications (ICH Q6A)
📌 In-use stability
📌 Microbiological aspects of stability testing
Meet our experts:
👤 Abderrahman Bojazar, Area Specialist, Novo Nordisk A/S
👤 Mikkel Pind, GDP & Anti-Counterfeit Specialist, H. Lundbeck A/S
👤 Helle Mulvad , Quality Assessor, Danish Medicines Agency
👤 Carsten Worsøe, Principal Scientist, Novo Nordisk A/S
👤 Ditte Hougaard Vestergaard, QA Manager, Ascendis Pharma A/S
👤 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
Practical information:
📅 Date: March 12-14, 2025
💼 Language: English
#Pharmakon #Stabilitetsstudier #LifeScience
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