Understanding regulatory legislation is vital for successfully navigating the complex global clinical trials market and ensuring the timely supply of your Investigational Medicinal Products (IMPs). In Europe, the Qualified Person (QP) plays a crucial role in bringing safe and timely products to the market. For pharmaceutical companies based outside of Europe, it is important to understand European GMP requirements and the role and responsibilities of the QP. Supplying into these countries requires planning, regulatory experience, GxP compliant facilities, robust processes and critically a QP named on the licence in region, that is conversant on the environment and on how to get your novel or well-established medicine to market. How do you ensure that the QP certification is swift and efficient?
Watch this webinar to learn more about:
- Expectations and responsibilities of the QP for release of drug product for clinical trials and commercial supply in EU
- New regulatory horizons in the UK & how to ensure supply continuity across Europe
- Best practices required to efficiently gain QP release – for clinical and commercial products manufactured in North America and other countries outside the EU
- Case studies to demonstrate the seamless process of QP release and timely supply