This course covers the requirements for conducting Clinical Studies across the EU via the requirements of the EU Clinical Trial Regulation (for Drugs & Biologics). The course also covers recent updates on EU-GCP associated with the new regulatory framework and highlights of the new EU Pharmacovigilance Directive, as it relates to studies and helpful tips into working with the European regulators. The webinar covers the impending changes coming with the EU Parliament passage of the EU Clinical Trial Regulation, which will affect all trials conducted across the EU [new and ongoing].
This course also covers the various licensing methods (for Drugs, Biologics & Combination Products) by which applicants can file for product licenses (Marketing Authorizations) in one or multiple Member States [and EEA], as well as fully across all Member States of the European Union. This course specifically outlines and discusses the structure of the regulatory agencies at the EU-level and across specific Member States. Course content will explain which procedures are available for which products and then will follow the license processing steps for each pathway.Learning Objectives
Attendees will leave the Course clearly understanding the requirements under the current Regulations. In addition, this Course has been updated to provide participants with competitive insight into:
- How the EU and individual countries within Europe interact
- Which registration procedure to use
- How regulations effect product development strategies
- Understanding the concerns/issues of European Regulatory Personnel
- How to negotiate with the regulators
- Information necessary for effective submissions
- Strategies for streamlining the registration application process for faster approval
- The advantages and disadvantages of various registration procedures
- How to efficiently initiate trials first patient, first visit
- How to link the strategy of Country Selection to an ultimate EU registration pathway
- How to stay compliant What can make the difference in your data passing Regulatory scrutiny
- Related area-GCP and PV-reporting updates
- Impending Changes of the EU Clinical Trial Regulation and timing for Implementation
- Business Management
- Project Team Members
- Legal Team Members
- Clinical Operations Staff
- Quality Assurance, Monitors, CRAs
- Regulatory Affairs
- Investigators & Site Study Staff
- CROs, Consultants, Insurers
GlobalCompliancePanel is a training source that delivers diverse, high quality regulatory & compliance trainings. These trainings are simple while being relevant and cost-effective while being convenient.
GlobalCompliancePanel imparts knowledge of best practices across a broad range of user-friendly mediums such as webinars, seminars, conferences and tailored, individualized consulting. These help organizations and professionals implement compliance programs that meet regulatory demands and put business processes in place.GlobalCompliancePanel focuses primarily on providing extensive and quality training in these core areas and anything related to them:
- Risk Management
- Regulatory Compliances
- Corporate Governance
- Quality Management
Through the mediums by which we offer trainings, namely webinars, seminars, conferences and consulting, we bring together the regulators or experts on regulation on the one hand, with the community that needs to learn or be aware of those regulations, on the other.
Professionals who undergo trainings from GlobalCompliancePanel exhibit a vastly improved quality of life in which there is increased productivity and professional growth. In the 10 years for which it has been in the professional trainings industry; GlobalCompliancePanel has developed a rich legacy of courses. It boasts an amazingly large repertoire of 5000 courses, which consist of over 2000 in-person seminars. ...