Personnel and specialists from QA, QC and Regulatory Affairs departments in the API and pharmaceutical industry
Personnel from contract development and manufacturing organisations
Representatives of EU inspectorates and regulatory authorities
Objectives
Analytical methods that were not “stability-indicating” are frequently cited in FDA 483s and Warning Letters. This course will thus address how to set impurity limits for related substances and degradation products based on method capability and stability results.
This course is intended to provide information on different aspects of stability testing. The course will be opened by an overview of stability testing with a special focus on the ICH Guidelines. In the subsequent presentation, important aspects of stability testing for biologicals and throughout drug development are discussed. Another lecture focuses on stability testing for Drug Substances, followed by a talk on Drug Products. In a further presentation, the focus lies on the various aspects of submitting stability data. Finally, statistical considerations will be covered in another lecture.
Programme
Current ICH and CHMP Guidelines for Stability Testing
Overview of Stability Guidelines
Concepts of Stability testing
Retest period and Shelf-life
Post-marketing Stability Studies
Future Activities
Stability Testing for Biologicals
Overview of regulatory requirements
Types of stability studies for Biopharmaceuticals
Practical aspects of stability studies with Biopharmaceuticals
Degradation pathways
Setting shelf life during early and late stage development
Stability Testing throughout Drug Development
Must the development stability programme meet ICH Q1A?
Stability testing from early development to product launch
Clinical stability for comparators
Site specific stability
Stability Testing for Drug Substances
Stability protocols
Stress testing
Photostability testing
Documentation
Stability Testing for Drug Products
Strategy of Stability Testing
Performance of new Drug Products
Related Finished Products with existing substances
Follow-up Stability Testing
Submitting Stability Data
Regulatory Strategy Stability
Drug Substance and Drug Product Stability Data and Evaluation
Storage recommendations/labelling/SmPC
Stability studies, commitments post approval
Typical questions from authorities and answers
Evaluation of Stability Results – Statistical Considerations
Sample number and replication
Trend analysis
Outliers
Pooling of batch data
Shelf life prediction
Further Information
Venue Barceló Sants Hotel Plaça dels Països Catalans, s/n 08014 Barcelona Spain +34 (93) 503 53 00 sants@barcelo.com
Accommodation CONCEPT HEIDELBERG has reserved a limited number of rooms. You will receive a room reservation form/POG when you have registered for the course. Reservation should be made directly with the hotel. Early reservation is recommended.
Fees (per delegate, plus VAT) Non-ECA Members € 1,290 ECA Members € 1,090 APIC Members € 1,190 EU GMP Inspectorates € 645 The conference fee is payable in advance after receipt of invoice and includes dinner on the first day, lunch on the second day and all refreshments. VAT is reclaimable.
Presentations/Certificate The presentations for this event will be available for you to download and print before and after the event. Please note that no printed materials will be handed out on site and that there will not be any opportunity to print the presentations on site. After the event, you will automatically receive your certificate of participation.
Conference language The official conference language will be English.
Testimonials
