San Francisco, California
London, United Kingdom
This in-person training program on the new Clinical Trials Regulation and regulatory affairs aspects of medicinal product development in the EU will discuss:
- All regulatory aspects to ensure a smooth development, including how to obtain orphan medicinal product status from the EMA, as well as when to ask for scientific advice.
- How to integrate paediatric studies in the development plan and information regarding the special regulatory aspects of advanced therapy medicinal products and oncology medicinal products.
- The current system for clinical trials applications in the EU as well as the changes under the new Clinical Trials Regulation.
- How to avoid the current situation where a common protocol is proposed in all EU Member States that participate in a clinical trial but requests for amendments may result in country-specific changes that require subsequent amendments in other countries to maintain a common protocol.
- How the new regulation will change the way pharmaceutical companies handle the clinical trial approval process.
- Timelines for companies to start preparing for these changes and implementations to allow optimal preparation.
Upon completion of this course, each participant will have a comprehensive knowledge and understanding of development regulatory affairs. Participants will have learned the following:
- How to create a comprehensive regulatory plan
- How to obtain orphan medicinal product status from the EMA
- When to ask for scientific advice and how to do this
- How and when to integrate paediatric studies in the development plan
- What are the special regulatory aspects of advanced therapy medicinal products and oncology medicinal products
- How the clinical trial approval process in the EU works and how this will change
Who will Benefit:
This course is specifically designed for:
- Regulatory affairs officers and managers
- Clinical trial associates
- Clinical operations personnel
- Personnel in the pharmaceutical and biotech industries who need a thorough understanding of the regulatory issues involved in the development of new medicinal products within the European Union
- Individuals who are seeking to update their knowledge of recent regulatory changes and their impact on product development
Note: Use coupon code NB5SQH8N and get 10% off on registration.
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When & Where
Enhancing global compliance, creating a world where quality and compliance professionals, regulators, and government agencies come together to help the world comply with the intent and the spirit of laws, policies and mandates, ensuring continuous improvement in global operations, quality & safety.
Making sure that we are responsible corporate citizens helping our constituents build a more responsible enterprise, one which operates with high quality , under a code of ethics, and with process discipline to ensure greater shareholder returns.
Keeping things simple and straight forward , so that we all can indeed improve the quality of our processes, our work, our businesses and enhance compliance globally.
Being inclusive, giving the process experts ( & novices! ), compliance professionals, quality champions, and regulatory agencies a voice so that all of us can contribute and make a difference.