Successful Site Transfers for Generics - solid oral dosage forms & semi-solid topical dosage forms (EU Requirements)
Online Masterclass
- 4th - 5th December 2024
- 9.00am – 1.00pm CEST (UTC+2)
Trainer
Markus Veit
Watch the seconds elapse in
anticipation of the approaching event
Introduction
Transfers of manufacturing of medicinal products are complex projects. This is in particular given for generic products, where not only pre- post-change similarity must be demonstrated, but it must also be made plausible that bioequivalence to the reference product is still given and it must be evaluated whether a new biostudy is needed. In any case it is the obligation of the marketing authorisation holder to demonstrate the “sameness” of the products before and after thechange and to justify a biowaiver based on dissolution or in-vitro release data.
Key learning outcomes
Attendees of the masterclass will be able to answer questions related to site transfers of the manufacture generic medicinal products in the EU
- What regulatory requirements need to be followed for site transfers and major changes for generic medicinal products?
- What are the risks and critical factors in transfer projects and for major changes and how could they be mitigated and controlled?
- What are responsibilities of parties involved?
- What are appropriate acceptance criteria to assess sameness of the products before and after major changes
- Why is dissolution testing a key quality control of generic solid oral dosage forms
Who Should Attend
- The training is aimed at all persons with responsibilities at marketing authorisation holders for (contract) manufacture and regulatory compliance. Members RA-CMC teams responsible for the information provided in the dossier and respective variations. Personnel with various responsibilities at the current and receiving site, such as respon- sibilities for pharmaceutical quality systems and quality assurance, change control, qualification and validation, manufacture and batch release. QPs and heads of manu- facture and quality control.
Meet The Trainer
Prof. Dr. Markus Veit is the managing director of ALPHA-TOPICS GmbH. He studied pharmacy in Frankfurt, obtained his Ph.D. at the Julius- Maximilians University in Würzburg, and habilitated there.
He is a pharmacist with special training and experience in pharmaceutical analysis and validation. He is a member of the German pharmacopeial expert committee at BfArM. In the past 25 years, he has worked as a managing director in companies providing services for the pharmaceutical industry with a focus on pharma[1]ceutical development, testing, and regulatory affairs. At the same time, he designed and led numerous training and continuing education events for employees in the pharmaceutical and medical device industry
