intERAactions
IntERActions is a division of the ERA Consulting Group that has been established to provide training and continuing education events in biopharmaceutical regulatory affairs. ERA has broad experience in the field of biotech and other biological products and is able to share this wealth of knowledge and expertise with clients and other regulatory affairs professionals via educational and training events. As well as speaking at conferences, such as those organised by BIO, DIA and RAPS, we provide our own seminars and courses, which can be designed on request to meet individual needs. ERA regularly offers training courses in regulatory affairs, particularly relating to biotech products and other biological products. Our speciality is the European scenario. Courses can also be geared to a client’s particular needs and be held at the client’s own facilities.
can include the following topics:
Introduction to European regulatory affairs
- The history of harmonisation in the EU and the evolution of European regulatory procedures
- The EU system of directives, regulations and guidelines
- The Centralised and Decentralised (Mutual Recognition) Procedures
- The European dossier
- The structure of the conventional EU dossier with expert reports and tabulated formats
- Changes to the EU dossier in the light of ICH and the Common Technical Document (Cli)
Recent developments in Europe
- Procedures for filing variations on existing marketing authorisations in Europe
- Concepts of quality, consistency and comparability in Europe
- EU approaches on biosimilar (pseudo-generic) products
Other issues
- Requirements relating to minimising risks associated with Transmissible Spongiform Encephalopathies
- Requirements relating to the European Pharmacopoeia and the quality of starting materials