Signal and Risk Management in Pharmacovigilance MasterClass (3.0)

Overview The 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 [...]

Advanced Stability Testing of Pharmaceuticals MasterClass

Overview This public training course will cover the scientific principles of chemical and physico-chemical degradation of active substances and pharmaceutical products as well as the regulatory requirements to establish a retest period or shelf-life Who should attend? The course will provide practical advice for chemists and pharmacists [...]

Risk Based Monitoring – During & Beyond Covid MasterClass

Overview The principles of Risk-Based Quality Management (RBQM) and Risk-Based Monitoring (RBM) were introduced in the ICH E6 (R2) guidance several years ago and have been strongly encouraged by regulatory bodies since 2011. This training will explore lessons learned, challenges, and best practices for remote and centralized monitoring [...]

Design Effective Incentives MasterClass

Overview This course is designed to equip human resources professionals in developing and improving the use of variable pay to support annual business results. While management may oppose raising fixed costs such as base salary and allowances, owners and leaders of organizations generally embrace the use of variable [...]

Data Transparency in Clinical Trials and Fake News In-house Training

Some of the hot topics Become aware of the impact that falsified studies or data can have on the scientific community, public opinion, and the credibility of companies   Understand the principles of clinical data sharing & manage correlating needs   Assess the resources required to address data [...]

Safety Data Exchange Agreements (SDEAs) and PV Arrangements with External Vendors MasterClass

Overview It is common in our globalized world that, according to their specific and particular strengths and interests more than one pharmaceutical is involved in the marketing of a pharmaceutical product, even in the same geographical area or country. It is crucial and tightly required by the Regulatory [...]

CMC Readiness Challenge in case of Expedited Programs for Biotechnological Products MasterClass

Overview To ensure that therapies for serious conditions are approved and available to patients as soon as it can be concluded that the therapies’ benefits justify their risks, regulatory agencies have developed specific processes to speed the availability of new therapies, especially when there are no satisfactory alternative [...]

Advanced ESG: Principles and Practice MasterClass

Overview Environmental, Social, Governance (ESG) investing is gaining traction as mainstream players are now considering the financial and risk management benefits of adhering to some form of ESG integration and monitoring, while at the same time find the need to respond to the increasing demand for responsible investments [...]

Advanced Forecasting In-house Training

Introduction 2020 was a stark reminder of just how unpredictable the world is. As events unfolded and policy makers responded it was necessary for banks and other economic agents to continuously update their outlook on how the economy would respond. Markets initially lurched downwards, stocks, commodities [...]

Pharma Contract Drafting MasterClass

Overview The Contract and legal document drafting seminar is an intensive training event for lawyers, and paralegals,working in the the pharmaceutical industry, held over 4 consecutive half-day sessions. It will improve participants’ skills of writing clear, concise contracts with specific relevance to the pharmaceutical Industry, including collaborative research [...]