Vendor/CRO Management and Oversight MasterClass

Overview With regulatory inspectors increasingly finding issues with vendor oversight by sponsor organisations, it is becoming even more important for the pharmaceutical industry to employ efficient and accurate strategies for managing outsourced activities. A company’s ability to identify and select the right CRO/ vendor for the right project [...]

The OECD Principles of Good Laboratory Practices (GLP) MasterClass

Overview The understanding, development, implementation, follow-up and improvement of the GLP Principles is fundamental for the application of non-clinical health and environmental safety studies. The GLP Principles are mandatory for non-clinical safety testing of test items in pharmaceutical products, pesticide products, cosmetic products, veterinary drugs as well as [...]

The EU Clinical Trial Regulation MasterClass

Overview The new EU Clinical Trial Regulation (536/2014) will replace the European Clinical Trials Directive (2001/20/EC) in 2022. Key aims of the new Regulation are to harmonise procedures for carrying out clinical trials across the EU and to simplify the clinical trial approval dossier by submission through a [...]

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 [...]

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 [...]