The webinar by Scendea provides an awareness of the regulatory environment for medicinal products and an appreciation of some of the main regulatory processes.
The global regulatory landscape is ever-changing in line with updates to scientific guidance, legislation and regulatory precedent. Product development and regulatory strategy should be informed by knowledge of global drug development pathways and tailored to the product type, intended therapeutic indication, and the target pathway for registration.
During the webinar Scendea share:
- An overview of drug development and regulatory pathways in the EU/UK and US.
- Key considerations for clinical trial development, product classification and licencing for an early-stage Biotech.
- Insight into EMA, MHRA and FDA programs to support development and expedite time to market.
- Approaches to regulatory interactions.
Webinar attendees will gain knowledge of drug development, regulatory pathways, agency interactions, and structure of the eCTD, as well as an understanding of the benefits of regulatory strategy and how this can optimise product development.
Register here (a link to the webinar will be sent to registered participants):
About Scendea: A leading product development and regulatory consulting practice serving the pharmaceutical and biotechnology industry. Read more here.
