training programme in pharmaceutical medicine clinical development

Transcription

1 training programme in pharmaceutical medicine clinical development nov 2010

2 clinical development november 2010 Local: INFARMED, Lisboa Curricular Unit Leader: Miguel Forte, MD, PhD Lecturers: José Antunes, Isabel Boaventura, Nathalie Clerget, Miguel Forte, Miguel Gomes, Sree Haran, Cecília Martinho, Raquel Reis, Cristina Sampaio, Graça Silveira, Faria Vaz, Luis Veloso, Beatrice de Vos. Organisation: Mestrado em Biomedicina Farmacêutica (Masters in Pharmaceutical Biomedicine) Curso de Especialização em Medicina Farmacêutica de Longa Duração (Post-Graduate Course in Pharmaceutical Medicine) Director: Luis Almeida, MD, PhD, FFPM Deputy Director: Bruno Gago, PharmD, PhD ua.pt) Address: Secção Autónoma de Ciências da Saúde (SACS) Universidade de Aveiro Campus Universitário de Santiago Edifício III Aveiro Portugal Tel Fax

3 Day november Time Programme Lecturer 1. Clinical development program 09h00-11h00 11h30-13h00 13h00-14h00 14h00-15h00 15h00-16h00 16h00-17h00 17h00-18h Clinical Development Program: Clinical and regulatory strategy; Operational options; Overall risk/benefit; Development milestones; Go/No-go decisions Clinical Development: Learn and Confirm: Impact of preclinical and clinical pharmacology data; Proof of concept trials; Dose finding trials; New trials designs; Exploratory vs. confirmatory trials; Superiority vs. noninferiority; Non-interventional/observational study. (Lunch) 2. Confirmatory Development 2.1. Planning and Global Coordination /harmonization of pre and post MA clinical trials: Available non-clinical and clinical data; Safety/efficacy perspectives; Regulatory accepted/required end-points; Local/global regulatory requirements; Geographic specificities: opportunities and challenges Definition of Clinical Trials Strategy: Target therapeutic indications; Target population; Decision points; Target product profile; Commercial strategy Life-cycle management: Extension of MA; Post-marketing studies; Quality of life 2.4. Regulatory perspective in clinical development: Regulatory guidance; Regulatory advice; Development partnership. Miguel Forte (UA, TXCell) Beatrice De Vos (Promethera Biosciences) Beatrice De Vos (Promethera Biosciences) Miguel Forte (UA, TXCell) Miguel Gomes (INFARMED)

4 Day november Time Programme Lecturer 3. Planning and conducting a Clinical Trial 09h00-10h00 10h00-11h00 11h00-12h00 12h00-13h00 13h00-14h00 14h00-15h00 15h00-16h Clinical trial design: Open label / controlled; Placebo vs comparators; Patient population and inclusion/exclusion criteria; End-points; Sample size; Statistical analysis (SAP) Clinical trials in special populations: Pediatrics; Geriatrics; Rare diseases; Gender, racial and ethical considerations 3.3. Study Documentation preparation: Protocol outline/full; CRF; Data collection; IC Defining study locations: Criteria; Feasibility assessment; Investigator recruitment; Investigator training and meeting. (Lunch) 3.5. Investigator site management: GCP; Site monitoring; Pharmacovigilance; Study medication; Audits Study Committees: Steering committees; Data monitoring committees; Codebreaking; Interim analysis; Premature termination. Cristina Sampaio (EMA & FMUL) Cristina Sampaio (EMA & FMUL) Luis Veloso Graça Silveira Graça Silveira Isabel Boaventura (Celgene) 16h00-18h00 4. Issues and challenges in Clinical Development Sree Haran (Transcrip-Partners LLP, UK)

5 Day november Time Programme Lecturer 5. Project Management 09h00-10h00 10h00-11h Resources and budget: Internal resources; CRO Contractual agreements: Investigators; CRO and vendors. 6. Vaccines and ATMP Raquel Reis 11h00-12h Clinical trials with vaccines Beatrice De Vos (Promethera Biosciences) 12h00-13h Clinical Trials with ATMP: Cell therapy Nathalie Clerget (TxCell) 13h00-14h00 (Lunch) 7. Clinical Trials in Portugal 14h00-14h A case study Isabel Boaventura (Celgene) 14h30-16h Round Table Faria Vaz (CEIC & ARSLVT), José Antunes (Janssen- Cilag), Cecília Martinho (AIBILI) plus other UC Lecturers

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