Regulatory: Pharma

This seminar looks at the latest guidance on how to prepare a clinical overview and summary in accordance with regulatory expectations and to comply with the requirements of the Common Technical Document (CTD).

This must-attend event will provide an essential overview of the opportunities and challenges presented by orphan drug regulation.

A comprehensive overview of FDA procedures, requirements for marketing authorisations and recent developments affecting the drug approval process in the US

A two-day event that will provide an invaluable overview of the EU system for variations, with practical advice on the preparation and submission of variation applications using the various European procedures.

The regulatory requirements for Biological drug products are complex, and pharmaceutical companies are continuously under pressure to ensure regulatory compliance from drug discovery to post-marketing surveillance. This course has been designed to help you navigate the complex regulatory requirements for biological drugs, including ATMPs. It will clearly depict the differences between small and large molecules and the development approaches which reflect the type of molecule. It will address the key aspects of the CTD, look at the CMC regulatory requirements during different stages of development, and discuss the importance of change control.

This course will allow participants to explore the regulatory landscapes governing AMR, discover innovative solutions and understand the challenges AMR poses across different sectors.

This introductory course provides a clear and practical foundation in toxicology. It covers key principles, terminology and testing methods, helping participants confidently interpret and apply toxicological data in chemical safety and compliance contexts.

Whether you’re looking to optimise existing processes or lay groundwork for a digital transformation, the course will teach the tools to leverage Digital CMC as a cornerstone of Pharma 4.0 success.

In this webinar, we will discuss the major requirements and strategies for nitrosamines, a hot topic that is on the forefront of many company's minds.