2019

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

Day 1 – 26. 9. 2019

Morning session 1 (9:00–10:30, 2 × 45 min)
Topic 1: ICH M9 – BCS
Henrike Potthast (BfArM, PKWP): ICH M9 – BCS Guideline – overview of comments
Martina Nora Odložilíková (Consultant): ICH M9 – BCS Guideline – industry perspective


10:30–11:00 Coffee break

Morning session 2 (11:00–12:30, 2 × 45 min)
Topic 2: EMA Scientific Advices
René Anour (AGES): Biosimilar PK trials and an Agency's perspective to EMA Scientific Advice
Nathalie Masson (Unither Pharmaceuticals): EMA Scientific Advices – industry perspective


12:30–13:30 Lunch

Afternoon session 1 (13:30–15:00, 2 × 45 min)
Topic 3: ICH M10 – Bioanalytical Method Validation
Philip Timmerman (EBF): ICH M10 – Feedback and comments from the European Bioanalysis Forum
Maria Caturla (Anapharm Bioanalytics): ICH M10 – Bioanalytical Method Validation – industry case studies


15:00–15:30 Coffee break

Afternoon session 2 (15:30–17:30, 2 × 45 min plus 1 x 30 min)
Topic 4: WEU
Jana Klimasová (SUKL): Well-established use - principles, requirements and case-studies
Marina Feřtek (Consultant): WEU procedures – reflection of reality

Topic 5: Future trends
Alassane Ba (Centre Humanitaire des Métiers de la Pharmacie): Panafrican agency


Day 2 – 27. 9. 2019

Morning session 1 (9:00–10:30, 2 × 45 min)
Topic 6: LALA topicals 
Flavian Radulescu (Universitatea de Medicina si Farmacie "Carol Davila"): Draft guideline on quality and equivalence of topical products
Volodymyr Stus (Polpharma): Draft guideline on quality and equivalence of topical products – case study


10:30–11:00 Coffee break

Morning session 2 (11:00–12:30, 3 × 30 min)
Topic 7: Dissolution/development
Jean-Michel Cardot (Université d’Auvergne): Dissolution for specific products e.g. vaginal rings, IVIVC, suspensions
Jiři Hofmann (Zentiva): Simulations – bootstrapping, Q and A
Paulo Paixão (Universidade de Lisboa): Dissolution profile comparison using different statistical approaches – f2 bootstrapping


12:30–13:30 Lunch

Afternoon session 1 (​13:30–15:30, 2 × 45 min plus 1 x 30 min)
Topic 8: Product specific guidelines/ BE
Susana Almeida (Medicines for Europe): Harmonization of BE requirements – harmonization of reference products
Paola Coppola (MHRA): EMA product specific guidelines

BB team: BioBridges 2019 – concluding remarks

15:30 Coffee and End of meeting