Extractables And Leacheables In Drug Development

Leachables from pharmaceutical container closure systems can present potential safety risks to patients. Extractables studies identify potential leachables and therefore assess and mitigate the above risks based on the dosage forms and the administration route. When safety concerns are detected, approaches for the toxicological evaluation of extractable and leachable have been developed and applied by pharmaceuticals and biologics manufacturers.

These approaches may differ depending on the nature of the final drug product, the formulation, the route of administration and the length of use. Available regulatory guidelines provide compound-specific indications but do not provide a general and comprehensive approach to safety evaluations of leachable and/or extractable. This webinar provides a general overview of this topic and the possible approaches to safety evaluations of extractable and leachable.

An effective extractable and leachable evaluation is essential for the overall success of any pharmaceutical drug development program for both small molecules and biologicals agents. In this webinar expert speaker, Stefano Persiani will focus on the basics of an effective extractable and leachable program. A case study will be presented to further provide a focus on the concepts discussed.

Areas Covered in the Session :

• Understanding the different types of extractable and leachable
• Recognize the importance of extractable and leachable evaluations
• Learn the necessary steps of extractable and leachable evaluations
• Learn how to deal with extractables and leachables associated with potential safety concerns
• Learn the concept of Permitted Daily Allowance
• Recognize the difference between extractable and leachable assessment when the active ingredient is a small molecule or a biological product
• Influence and motivate cross-functional colleagues to embrace their critical roles in successful extractable and leachable evaluation programs

Who Should Attend:

• Project managers
• Regulatory affairs
• Pharmaceutical development scientist
• Toxicologists
• Drug discovery scientists
• CMC scientists
• Clinical development scientists

Course Director: DR. STEFANO PERSIANI ‎

Dr. Stefano Persiani is currently Director of Translational Sciences and Pharmacokinetics at Rottapharm Biotech, Italy. He graduated in Pharmacy at the University of Milan, Italy and completed a Post-Doctoral fellowship in the Department of Pathology of the University of Pittsburgh School of Medicine, Pittsburgh, Pennsylvania, USA. Dr. Persiani was later a Research Associate in the Department of Pharmaceutics of the University of Southern California, School of Pharmacy in Los Angeles, California, USA. After these academic positions, he entered the pharmaceutical industry at Farmitalia Carlo Erba, Pharmacia, Upjohn, and Zambon Group and in the CRO sector as Scientific Director for Clinical Pharmacology. Dr. Persiani in his current role applies translational approaches from drug discovery to registration in several therapeutic areas. Dr. Persiani is a member of various international scientific societies, serves on the review board of numerous professional journals, and acts as an external expert for the European Commission on the 7th Framework Program, HORIZON 2020, Marie Sklodowska-Curie Individual Fellowship Program, and Innovative Medicine Initiative. He also acts as an external expert for the La Caixa Foundation (Spain) and for the Research Agency of the Check Republic. Specialities: Drug and biopharmaceutical discovery and development; from pre-clinical to clinical Phase I, and IIa. Dr. Persiani gives courses and consults in the above fields at the University of Milan Bicocca, University of Chieti, University of Bologna, University of Rimini, Thomson Reuter, IIR, Life Sciences Strategy, Informa life sciences, Health Communication Network, Vision in Business, Pharmaceutical Training International, GRC Educators, Trainning.com, and MPG Media.