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CMC Biopharma MasterClass

27 July - 28 July

Training OverviewThis MasterClass will provide a deep and detailed instruction on Chemistry, Manufacturing, and Controls (CMC) requirements and review processes for clinical trial, registration, and postapproval drug applications. Attendees will also have a solid but comprehensive overview of all relevant regulatory, technical, and quality elements, implementation, and documentation of the required CMC analytical and stability…

Development of generics: From R&D to GMP MasterClass

28 July - 29 July

Training OverviewThe interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. R&D needs flexibility and should not be over-regulated, whereas GMP concentrates on standardization and high throughput. On the other hand, R&D has to create a solid and robust fundament to enable manufacturing and quality control to work according…

Risk & Pharmacovigilance MasterClass

30 July - 31 July

Training OverviewThe focus of this two days training will be on providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide the participants with practical advice on RMP drafting and preparation as well as the accessor's point of view in evaluating an RMP. On…

Pharma Packaging and Technical Operations MasterClass

13 August - 14 August

Training OverviewThe online training course will support you in collecting, sorting, and proper understanding of the requirements of the procedures of pharma and healthcare packaging and technical operations. The trainings curse will also focus on anti-counterfeiting, serialisation, and tamper evidence on the packaging of medicinal products. Generally, the course will cover a 360-degree view on…

Pharma Mergers and Acquisitions MasterClass

05 November - 06 November

Training OverviewThis 2 day programme is intensive, and aimed at participants who wish to understand the various legal aspects of M&A in its different facets, it addresses the deal process, key documents including the Share Purchase Agreement, Disclosure Letter, specific issues Due Diligence in Life Sciences including IP, IT and Regulatory Warranties in Life Sciences…

Signal and Risk Management in Pharmacovigilance MasterClass

19 November - 20 November

Training OverviewThe focus of this two days training will be on providing an update of ongoing activities regarding medicines’ risk and signal management. The first day will be an opportunity to provide the participants with practical advice on RMP drafting and preparation as well as the accessor’s point of view in evaluating an RMP. The…

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