Developing Internal Regulatory Expertise
How to Design a FIH IND Enabling Program
This course prepares particpants to design high quality IND enabling development plans based on ICH M3 and associated ICH guidelines that will leave you with a comprehensive understanding of regulatory requirements in all major geographies. Case studies and real world examples are used to demonstrate principles and ensure concepts are well understood. The course is designed to be a full day. COST: $7500 USD
How to Assess Regulatory Risks
This course presents a detailed framework for assessing regulatory risk in any scenario following a set of core principles that can be universally applied to arrive at a mitigation plan for any regulatory challenge. This course is 2 hours. COST: $375 USD
How to Develop a Regulatory Strategy
This course presents a detailed framework for developing a regulatory strategy that takes into account the unique attributes and characteristics of your asset, your organization's objectives, and the current phase of development. This course is 3 hours. COST: $500 USD