2018

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Day 1 – 26. 9. 2018

Institute of Pharmacology | First Faculty of Medicine | Charles University in Prague | Albertov 4, 128 00 Prague 2 | Czech Republic

Morning session 1 (9.00 – 10.30, 2 × 45 min)
Slot 1 Bruno Sepodes (EMA, COMP): Challenges and Opportunities for Orphan Medicinal Products under the European Regulatory Framework
Slot 2 Tomáš Hauser (Zentiva): Repositioning of existing API – industry perspective

Coffee Break (10.30 – 11.00)

Morning session 2 (11.00 – 12.30, 2 × 45 min)
Slot 1 Blanka Hirschelorvá (SUKL): EU SUPAC – Draft ICH guideline Q12 on technical and regulatory considerations for pharmaceutical product lifecycle management
Slot 2 Jean-Michel Cardot (Université d’Auvergne): Evaluation of dissolution similarity – Bootstrap, MSD

Lunch (12.30 – 13.30)

Afternoon session 1 (13.30 – 15.00, 2 × 45 min)
Slot 1 Barbora Ladinová (SUKL): Biologics – Guideline on the requirements for quality documentation concerning biological investigational medicinal products in clinical trials
Slot 2 Stefan Horkovics-Kovats (SHK): Comparison of dissolution time profiles: No similarity but where is the difference?

Coffee Break (15.00 – 15.30)

Afternoon session 2 (15.30 – 17.30, 3 × 30 min, 30 min discussion)
Slot 1 Henrike Potthast (BfArM, PKWP): ICH M9 – Guideline in development on Biopharmaceutics Classification System (BCS)-based biowaivers
Slot 2 Susana Almeida (Medicines for Europe): Major role of excipients in the draft guideline ICH M9
Slot 3 Sebastian Härtter (Boehringer-Ingleheim): ICH M9 – Acceptance of in vitro permeability data

 

Day 2 – 27. 9. 2018

Morning session 1 (9.00 – 10.30, 2 × 45 min)
Slot 1 Paola Coppola (MHRA): PKWP – BE/PK position on specific questions
Slot 2 Jan Šus (Zentiva): PKWP – Industry perspective – crushed tablets

Coffee Break (10.30 – 11.00)

Morning session 2 (11.00 – 12.30, 3 × 30 min)
Slot 1 Helmut Schütz (BEBAC): Multi-Group Studies in Bioequivalence. To pool or not to pool?
Slot 2 Marina Feřtek (Consultant): Multi-batch approach in BE testing – Multi-batch in clinical studies, which one to use in a final BE study
Slot 3 Vít Perlík (BioBridges): BioBridges 2018 - Regulatory Year in review – new draft guidelines

Lunch (12.30 – 13.30)

Afternoon session 1 (13.30 – 15.00, 2 × 45 min)
Slot 1 Flavian Radulescu (University of Medicine and Pharmacy): Locally applied, locally acting products – Topicals – in vitro comparison
Slot 2 Reynald Magnier (Ceva): Ecotoxicology studies – Return of experience from Veterinary pharmacy and potential gain for Human medicine

Coffee Break (15.00 – 15.15)

Afternoon session 2 (15.15 – 16.15, 2 × 30 min)
Slot 1 Anders Fuglsang (Fuglsang Pharma): Sponsor duties – Auditing CRO and monitoring of BE studie
Slot 2 Volodymyr Stus (Polpharma): Application of Guideline on clinical development of fixed combination medicinal products (EMA/CHMP/158268/2017) in real life: different indications – different requirements, strength biowaivers


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