Quality in Pharmaceuticals

Friday 2nd October (lessons 1&2), Friday 9th October (lessons 3&4) and Friday 16th October (lessons 5&6); 9-12 and 13-16

Ms Sabrina Lafifi, Head of Quality & Responsible Person – EMNA Group

Lesson 1 : From Idea to Medicine: Pharmaceutical Development and Clinical Studies

• Stages of pharmaceutical development (R&D, formulation development, preclinical stages)
• Phases of clinical trials (I to III): objectives, design, regulatory requirements
• Good Clinical Practices (ICH GCP) and the role of Quality Assurance in studies
• Document management and traceability from the early phases
• Initial stability studies and definition of primary packaging

Lesson 2 : Regulatory Submission and Market Authorization

• Marketing Authorization Application dossier (CTD – Common Technical Document)
• Interactions with regulatory authorities (Swissmedic, EMA, FDA, etc.)
• Role of Quality Assurance in data compilation and verification
• Site qualification, pre-inspection audits, and inspection readiness
• Implementation of the local quality system for the Marketing Authorization Holder

Lesson 3: Pharmaceutical Manufacturing and Quality Assurance (GMP)

• Good Manufacturing Practices (EU GMP, PIC/S, Annexes)
• Control of manufacturing processes and in-process controls
• Management of deviations, CAPA, and change controls
• Process validation and cleaning validation
• Batch release by the Responsible Person (Switzerland)
• To be combined with an on-site visit

Lesson 4: Quality Management in Distribution and Supply Chain (GDP)

• Good Distribution Practices (GDP)
• Qualification of suppliers and subcontractors
• Traceability and serialization
• Management of transport, temperature control, and excursions
• Management of recalls and batch withdrawals

Lesson 5: Pharmacovigilance and Post-Marketing Surveillance

• Pharmacovigilance and materiovigilance: definitions and legal obligations
• Risk management and adverse event reporting
• PV system audits and inspections
• Role of Quality in PV system compliance
• Link between Quality, PV, and product benefit-risk balance

Lesson 6: Pharmaceutical Quality Management System Throughout the Product Lifecycle

• ICH Q10 principles – Pharmaceutical Quality System
• Product lifecycle management (ICH Q12)
• Management Review, Quality Metrics, and continuous improvement
• Quality governance and quality culture within pharmaceutical companies
• Cross-functional collaboration between RA, QA, QC, Supply, PV, and Clinical departments

UNIGE, CMU, room TBD

1 for 6 hours /1 day

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