The pharmaceutical and biotech industries are the most regulated in the world due to the nature of the product. Patient safety is central to all decisions, processes, procedures, guidance and regulations. Regulatory agencies such as the MHRA and EMA are in place to ensure new and existing products meet stringent safety requirements. As a professional working in the sector it is important for you to fully understand the regulations
This introductory course will provide you with a grounding knowledge of regulatory affairs in Europe. Over 4 weeks and 8 modules you will gain a clear understanding of the EU regulatory structure and a solid grasp of the submission process including the standards required by the regulators.
This course will give you a practical insight into the European regulatory environment throughout the whole product life cycle including: non-clinical and clinical studies, the various submission procedures, labelling and packaging, post-MAA obligations and activities. and more.
Sophie has over 20 years of experience in the pharmaceutical industry. She gained her Master’s degree in analytical chemistry from Manchester University and her Chemical Engineer degree from Montpellier School of Chemistry. She went on to work in pharmaceutical development and post-marketing CMC regulatory compliance in companies such as Bayer, Stragen, PregLem and Laboratoires Galderma. She gained a strong experience in the worldwide regulatory environment for the manufacture and control of the medicines.
She now runs her own consultancy, delivering consultancy and support in writing IMPDs, CTD Module 3 and QOS, preparing variations and answering questions from health authorities.
Sophie also delivers training courses on European regulations for pharmaceuticals, writing of the Module 3, how to achieve global regulatory compliance, managing transfers of manufacturing sites and preparing variations for the ASEAN region.
Those new to Regulatory Affairs or wishing to update their knowledge on European regulatory affairs
Online academy is a new online, interactive and engaging education tool designed to maximise learning for professionals with busy schedules and/or small training budgets.
The online academy brings alike professionals together and gives you the opportunity to share ideas and questions via the discussion forum creating your own professional community. Our on-demand feature means the content is available as and when you need it allowing greater flexibility to your professional development and learning.
The online sessions allowed me flexibility to fit training into my busy work schedule.
This course suited me perfectly in a busy time period. The possibility of completing each module around my schedule was very appealing. If you have little or no experience of the regulatory world, I would recommend this course as it gives a good overview of the full regulatory dossier.
Once you have registered you will be given login details to access the course