Pharma Classes EU 2025 (Ads)

Trainer:  Sophie Nageotte

 
-Understand the different levels of requirements during the drug development and the post-approval phase 
-Experience the development of biotherapeutics from Discovery to Market approval
-Learn about the key stakeholders and their legal scope (competent authorities, ICH, pharmacopoeias)
-Understand the Strains and Cell line development
-Learn the basic CMC data requirements on drug substance and drug product on key topics: process and analytical validation, compendial vs non-compendial excipients, setting specifications, packaging, stability
-Have a chance to meet the Requirements and technical approach for Phase I, Phase II, Phase III clinical trials
-Have an overview of the CTD dossier and a detailed review of the CTD Module 3
-Learn about the Control strategy life cycle
-Get an introduction to quality by design and ICH guideline Q12

Trainer:  Pearl Pereira

-Comprehensive Understanding: Master Regulatory and Pharmacopeial standards for drug substance and product specifications.
-Immediate Applicability: Develop and justify specifications across dosage forms oral, parenteral, topical, inhalation, and more.
-Acceptance criteria setting: Characterize and Control impurities and set clinically relevant dissolution specifications.
-Report writing skills: Write scientifically sound characterization of impurities and justification of specification reports.
-Navigate regulatory submissions with confidence: Address regulatory queries and prevent deficiencies in drug applications.
-Interactive Learning: Engage in hands-on, interactive sessions that reinforce your learning through practical exercises and case studies

Coach: Manfred Fischer   

-Insight into the regulatory guidance documents

-Understand, how to interpret the guidance documents of a specific application

-Deep insight into the analytical documentation in terms of procedures and validation

-Understand, how to perform a successful transfer of analytical procedures

-Understand, how to establish comprehensive specification for drug substances and products

-Overview of the analytical procedure life cycle

-Insight into the documentation for stability studies

-Understand the key aspects for the justification of specification

-Overview of the documentation needed for a submission

Trainer:   Hervé Broly & Myléne Talabardon

-Understand how to qualify scale-down models, to assess the criticality of quality attributes (CQAs), material attributes (CMAs) and process parameters (CPPs).
-Propose methods to build up process characterization studies looking at interactions between CQAs/CMAs and CPPs and determining the acceptable ranges of process parameters to deliver quality product.
-Learn how to perform clearance of impurities, worst-case studies and excursion studies
-Understand how to set-up a control strategy
-Learn on the qualification of cell banks.
-Understand how to assess microbiological risks (including viruses) during manufacturing, toxicological risks related to raw materials, extractables/leachables from consumables and elemental impurities
-Learn how to perform viral clearance studies, mixing studies, resin and membrane lifetime studies, homogeneity and uniformity studies, freeze-thaw studies, shipment qualification studies, reprocessing studies, container closure integrity testing and validation of sterile filtration
-Provide guidance on the performance of stability studies related to process performance qualification
-Understand how to determine the number of process performance qualification (PPQ) runs, how to perform PPQ and how to assess PPQ-derived data.
-Provide guidance on the purpose and design of continued process verification

Coach: Mirko Gabriele  

-Understand industry approaches for Technology Transfer
-Get a valuable insight on the Dos and Donts for successful technology transfer starting from real life example
-Explore proven best practices for Technology Transfer of different drug product formulations
-Gain practical knowledge from interactive sessions and case studies
-Take the opportunity to discuss issues and challenges

Trainer:  Dominique Tytgat

-Basics of PK an PK/PD
-Emax/Imax models
-Operational model of agonism
-Understanding the PK/PD relationship (direct/indirect link models, indirect response models)
-Tolerance, rebound, physiological limits in drug response
-Target-mediated drug disposition of biologics
-More sophisticate models (categorical vs continuous effects; survival models; tumor models...)

Trainer:  Graeme Ladds

-Audits and expectations risk-based inspections
-Compliance and drug safety
-Overview of the PSMF in the EU
-Product safety reviews purpose and function (incorporating the latest EU signal analysis requirements)
-Safety reporting in licensing agreements
-Developing company core safety information (CCSI) CIOMS III
-PSURs timing, content and the DSUR and the latest ICH E2C (2nd revision requirements)
-Implications for safety reporting in global clinical trials
-Risk-benefit determinations
-Risk management plans (RMPs)