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https://fleming.events/signal-management-in-pharmacovigilance/ This practical course provides an in-depth understanding of signal detection, signal validation & assessment as well as signal communication. The series of talks, discussions & exercises will bring clarifications about the regulation & methodologies for signal detection, what to consider in signal validation and prioritisation, how to notify regulatory agencies and avoid inspection findings related to signal management. Topics Signal detection Signal validation & assessment Signal communication Benefits of attending Understand the regulations & guidance on signal management. Get an overview of qualitative and quantitative methodologies for signal detection. Explore the role of social media in signal detec…
23-Feb-2023 - 24-Feb-2023

https://fleming.events/new-ich-and-ema-quality-guidelines/ In summary, this course will help the delegates to identify important new GMP and Regulatory aspects which should be considered throughout the entire life cycle of their specific products and avoid waste of time and money, thereby. Key topics: ICH Q12 Lifecycle Management ICH Q13 Continuous Manufacturing EMA Guideline on quality documentation for medicinal products when used with a medical device ICH Q14 Analytical Procedure Development ICH Q2(R2) Analytical Validation Current EMA Quality Discussions and Initiatives Training audience: Regulatory affairs QA/QC Analytical Development R&D Scientists Manufacturing Scientists CMC GMP Regulators    
07-Mar-2023 - 09-Mar-2023

https://fleming.events/bioavailability-bioequivalence-and-biowaivers/ This practical course provides an in-depth understanding of  BABE design including all practical aspects related to bioavailability & bioequivalence. Key topics: Bioavailability and Bioequivalence BABE design Practical aspects Computation of PK parameters-statistical analysis Specific cases & legal aspects Biowaiver principles The use of different types of biowaivers Regulatory & legal aspects of biowaivers Development of dissolution tests as support of BE and biowaivers Dissolution Setting specifications Training audience: BA/BE managers Regulatory affairs professionals Pharmacokineticists Dissolution testing specialists IVIVC specialists Formulation managers Formulators Project Development Manager …

https://fleming.events/computerized-systems-validation-in-pharma-biotech/ This course is a compilation of topics representing recent challenges related to CSV, and how CSV relates to data integrity assurance. Key topics: CSV considerations around data integrity Auditing GXP computer systems Inspection trends around CSV and data integrity Requirements for e-signatures/biometric signature Shifting to a data perspective Data requirements for validation Data migration and interfaces Verification & testing methods Iterative prototyping & agile methods Physical & logical security System overview document IT incident & change management in a GXP context Training audience: This Training Course is of particular interest to Pharmaceutical & Biotech industry: CSV consultants,…

https://fleming.events/pharma-biotech-portfolio-management-training/ This course is designed for those who already have some experience in R&D project & portfolio management, decision analysis and prioritization, and wish to develop their skills and knowledge in the evolving portfolio management tools, techniques and strategies to maximize value and drive innovation. Key topics: Challenges of development business models for valuation and prioritization Utilizing technology to facilitate analysis and decision making Agile and Lean Portfolio Management for Pharma R&D Big data and Artificial Intelligence in Portfolio Management Organizational support for Portfolio Management Training audience: Pharmaceutical, Biotech and Life Sciences companies: R&D Portfolio Management R&a…