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Development of generics: From R&D to GMP MasterClass

06 October - 07 October

Training OverviewThe interface between Development and GMP units is one of the most exciting in the pharmaceutical industry. Mutual understanding of the different regulatory environment and the functional priorities is a key success factor. Conflicts, mostly resulting from different approaches and priorities, can have negative impact on business processes even outside the R&D or GMP…

Strategic Supply-Chain Management for Pharma and Biologics MasterClass

13 October - 14 October

Training OverviewSupply-chain management is now front and centre in the Pharma industry, as the CoVid-19 pandemic has revealed major shortcomings in response, flexibility and availability of products and materials. This training takes a strategic view of much needed improvements, tracing back to the early stages of drug development that often lead to issues in the…

Medicinal Global Regulations MasterClass

19 October - 20 October

Training OverviewThe expansion of global markets has resulted in increasing regulatory demands for the pharmaceutical industry. Many pharmaceutical companies are expanding their activities to new markets and regions. During this process, companies are facing challenges of coping and keeping compliant to diverse regulatory requirements and operating standards when it comes to Clinical trials and post…

Data Monitoring Committees MasterClass

26 October - 27 October

Training OverviewThis course will focus on practical issues around the workings of data monitoring committees (DMCs) including a review of group sequential methods and FDA and CMHP guidance on DMCs. Throughout the course, mock DMC sessions will be convened where various scenarios will be considered and discussed, and decisions have to be made. Key Takeaways:…

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…

Segmenting Pharma Markets in the Social World MasterClass

19 November - 20 November

Training OverviewFor many years, Pharma has been moving away from it’s ‘one-size fits all’ model towards a more bespoke, patient-centric model. The rise of new, highly targeted and specific medications, Biologicals and Bio-Similars has made segmentation an ever more important phenomenon for the Pharmaceutical industry. The rise of Social Media and particularly Social Listening has…

Biosimilars in the EU MasterClass

01 December - 02 December

Training OverviewThe market share of drug products manufactured by means of modern biotechnology is constantly increasing. In Germany, it is close to 25% in value. This means that there will be a major cost saving potential for the healthcare systems by introduction of Biosimilar competition. New therapeutic options are opened for treatment of severe medical…

Healthcare automation from Machine Learning to AI MasterClass

09 December - 11 December

Training OverviewThis 3-day online live course is intended to go through the complete roadmap that leads to the immense universe of Artificial Intelligence. It starts from ground zero, a quick overview of basic statistics and data analysis, pillars upon which both “supervised” and “unsupervised” Machine Learning evolved and became at their turn the inevitable backbone…

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