Agenda 2015
Transcription
Agenda 2015
Seminar 4.1 The Module 3 (CMC Dossier) of biopharmaceuticals The Module 3 of the CTD of biopharmaceuticals CMC data requirements of biopharmaceuticals Module 3 dossier and data requirements for biopharmaceuticals in the USA and Japan Relevant EMA and ICH CMC-related guidelines Special areas to be considered for biopharmaceuticals o Formulation and stability o Critical process and quality attributes o Isoform characterization and glycosylation of biopharmaceuticals o Potency determination o Comparability o Virus and TSE safety CMC data requirement for biosimilars CMC particulars of ADC Typical pitfalls in regulatory submissions 20 – 23 January 2015 Freiburg, Hotel Novotel am Konzerthaus, Room Colmar Course Leaders: Beatrix Metzner Boehringer Ingelheim Pharma GmbH & Co. KG Mairéad Duke Épée Services Ltd. Programme Day 1, Tuesday, 20 January 2015 09.15 – 09.30 Welcome and introduction Beatrix Metzner and Mairéad Duke 09.30 – 10.30 The structure of the Quality Module 3 of the CTD for biopharmaceuticals and the relevant guidelines This session provides an introduction into the Module 3 structure first which is used throughout the seminar as a kind of frame, in which the individual headings of the structure are embedded either as interactive sessions or as presentations. Mairéad Duke 10.30 – 11.00 Coffee break 11.00 – 11.30 First interactive session of the dossier and data requirements for the individual sections of the Module 3. For all interactive sessions, Beatrix Metzner and Mairéad Duke develop with the audience the content related to biopharmaceuticals and will summarise at the end of the session the essentials. EUCRAF. Seminar 4.1: www.eucraf.eu 20 - 23 January 2015 Programme Phone: +49 (0)761 13734424 Page 1 of 5 E-mail: [email protected] To start with: General information (3.2.S.1 and 3.2.P.1) 11.30 – 12.15 Manufacture (3.2.S.2. and 3.2.P.3) (Interactive session) 12.15 – 13.00 Control of Materials (3.2.S.2.3.) (Interactive session) 13.00 – 14.00 Lunch 14.00 – 16.00 How do ICH Q 8, 9 and 10 determine the Module 3 structure and content: Controls of critical steps and intermediates (3.2.S.2.4 and 3.2.P.3.4.) Process validation (3.2.S.2.5. and 3.2.P.3.5.) Manufacturing process development (3.2.S.2.6. and 3.2.P.2.) Beatrix Metzner 16.00 – 16.30 Coffee break 16.30 – 17.30 Continued 17.30 End of Day 1 19.00 Get-together with food and wine EUCRAF. Seminar 4.1: www.eucraf.eu 20 - 23 January 2015 Programme Phone: +49 (0)761 13734424 Page 2 of 5 E-mail: [email protected] Day 2, Wednesday, 21 January 2015 09.15 – 11.15 Characterisation of biopharmaceuticals (3.2.S.3) Parameters investigated Heterogeneity and isoforms Glycosylation Undesired modifications of molecules Potency determination Impurities Heike Volkmer, Volkmer & Burt Consulting Team 11.15 – 11.45 Coffee break 11.45 – 13.00 Control of Drug Substance / Drug Product (3.2.S.4. and 3.2.P.5.) (Interactive session) 13.00 – 14.00 Lunch 14.00 – 15.00 Continued 15.00 – 16.00 Virus and TSE-safety of biopharmaceuticals Selection of starting material Starting material and auxiliary material of animal and/or human origin used in the process or formulation of the medicinal product Virus validation of the manufacturing process capacity to inactivate and remove viruses and TSE Hannelore Willkommen, Regulatory Affairs & Biological Safety Consulting 16.00 – 16.30 Coffee break 16.30 – 18.15 Continued 18.15 End of Day 2 EUCRAF. Seminar 4.1: www.eucraf.eu 20 - 23 January 2015 Programme Phone: +49 (0)761 13734424 Page 3 of 5 E-mail: [email protected] Day 3, Thursday, 22 January 2015 09.15 – 10.45 Interactive session Reference Standards (3.2.S.5. and 3.2.P.6.) Container Closure System 3.2.S.6. and 3.2.P.7.) Stability (3.2.S.7. and 3.2.P.8.) 10.45 – 11.15 Coffee break 11.15 – 13.00 Interactive session The comparability exercise – what to do and what to present in the dossier when the manufacturing process is changed 13.00 – 14.00 Lunch 14.00 – 16.00 Formulation and drug product manufacturing of biopharmaceuticals • Formulation development • Process development • Routes of administration • Special developments to modify proteins and formulations Michael Ausborn, F. Hoffmann-La Roche Ltd. 16.00 – 16.30 Coffee break 16.30 – 18.30 Considerations for the CMC development and submission requirements for a drug-device combination product Florian Lengyel, Boehringer Ingelheim Pharma GmbH & Co. KG 18.30 End of Day 3 For Full Course Students (Gabriele Dallmann): 18.30 – 18.45 EUCRAF. Seminar 4.1: www.eucraf.eu Introduction to the homework 20 - 23 January 2015 Programme Phone: +49 (0)761 13734424 Page 4 of 5 E-mail: [email protected] Day 4, Friday, 23 January 2015 09.15 – 11.00 CMC particulars of biosimilars Beatrix Metzner 11.00 – 11.30 Coffee break 11.30 – 12.45 CMC particulars of ADC (Antibody Drug Conjugates) Mairéad Duke 12.45 – 13.45 Lunch 13.45 – 14.30 What is special in other regions on Module 3 requirements? USA Japan Other regions 14.30 – 16.30 Beatrix Metzner Regulatory CMC concerns and issues Jörg Engelbergs, Paul-Ehrlich-Institut 16.30 End of Seminar 4.1 EUCRAF. Seminar 4.1: www.eucraf.eu 20 - 23 January 2015 Programme Phone: +49 (0)761 13734424 Page 5 of 5 E-mail: [email protected]