Whitepaper

Pharmaceutical companies need to follow regulations set forth by respective regulatory agencies right from the pre-clinical to post-marketing phases of clinical development. Each and every regional agency has a wide range of stringent guidelines for various processes to ensure patient safety and product quality. New regulations are bound to be set to further enhance medical research as per changing industry trends. If any change occurs in regulatory regime, it is sponsors’ responsibility to track the revisions/modifications from time to time to adapt and align with them.

This Whitepaper discusses about

Current Challenges in Regulatory Affairs for Sponsors

• Process Challenges
• Technical challenges
• New Trends in Regulatory Affairs to Expedite Review Process

Notable changes in different types of regulations

• Framework to Use Real-world Evidence to Mitigate ‘Off-label’ Drug Usage
• CMC Post-approval Changes for Biologics
• Clinical Trial Regulation (CTR) & CTIS Portal
• IDMP Implementation Guide