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 have a solid grasp of the submission process and 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: clinical trials requirements, the structure of the registration dossier, biotech regulations, labelling and PV obligations.
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.
Salma Michor, PhD, RAC is the founder of Michor Consulting providing services to the pharmaceutical and medical device sectors, specializing in regulatory affairs, regulatory compliance, quality assurance, risk management and interim management. Michor Consulting is an established and licensed entity, and can act as your European Authorised Representative for CE marked medical devices. Dr.Michor serves as an independent expert for the European Commission since 2004, evaluating and reviewing industrial research projects for Small and Medium sized Enterprises(SMEs) and the Marie Curie Fellowships programme for the 6th and 7th Framework programmes.
Those new to Regulatory Affairs or wishing to update their knowledge on European regulatory affairs
Once you have registered you will be given login details to access the course
This online academy course can be accessed from Monday 6th November. Two modules will be uploaded per week, allowing you to study at your own pace. Your trainer will welcome any questions that arise throughout your course.
Please note that full payment must be made prior to the course start date in order to receive your login details to begin the course.