Registration and applications within the European Union can follow various procedures depending on the type of product and the objectives of the sponsor. The pharmaceutical industry is one of the highly regulated industries, with many rules and regulations enforced by the government to protect the health and well-being of the public. Therefore, the aim of the pharmaceutical industry is to identify and develop a generic drug product which can be tailor made to meet the diverse market requirements. This webinar will review each type of application, when it is required and when it is recommended, along with pros and cons of each type.
An experienced ex-regulator will deliver this course and provide a comprehensive overview of the regulatory filing requirements in Europe. The course will be of value to both those who are new Regulatory Affairs in the pharmaceutical, biopharmaceutical industries, as well as experienced professionals wishing to refresh their regulatory knowledge. Personnel whose responsibilities require knowledge of the EMA and European country regulatory environment, such as Project Managers and those in Clinical, Non Clinical, Manufacturing and Quality areas will also find this training highly relevant.
- How to choose the appropriate pathway to drug approval in the EU
- Steps required prior to submission of a marketing authorization application (MAA)
- Key timelines before, during, and after submission of an MAA
- Expectations of the sponsor during the review process
- Follow up on applications after approval
- Life cycle management of the MAA
- Vice Presidents, Directors, & Managers of regulatory, clinical and manufacturing areas
- Employees involved in any area providing information for a MAA
- All Regulatory affairs personnel working on EU submissions
- All companies developing drugs or biologics for approval in the EU