The Aggregate Safety Assessment Course

Do you want to enhance the ability to detect safety signals earlier in clinical development?

Do you want to ensure a more efficient and systematic characterization of the safety profile of your product which minimizes key missing data and ad hoc assessments?

Do you want to be better prepared for internal stakeholder communications and regulatory submissions and provide a convincing assessment of the product’s safety risks?

Many scientists (including statisticians/data scientists and clinical safety professionals) want the same and struggle with having a good process in place to achieve this.

The Aggregate Safety Assessment Course will enable you to comply with regulatory requirements for aggregate safety assessments throughout the development process.

• Greg Ball, PhD (Safety Statistician) – 36 years of experience; helping top 10 pharma companies to build their safety assessment process and pioneering many cross-pharma initiatives around aggregate safety assessments and cross-disciplinary scientific engagement.
• Barbara Hendrickson, MD (Drug Safety Physician) – 19 years of experience in drug safety across multiple therapeutic areas in both clinical development and post-marketing along with extensive regulatory submission experience.

Through the Aggregate Safety Assessment Course, you will be able to communicate the safety story of your compound consistently and authoritatively:

• When your safety profile emerges: Documented in the Development Core Safety Information and Investigators Brochure (Communicated out in the DSUR, ISS, CTD…) and
• When the iterative process of learning and decision-making continues: Documented in the Company Core Safety Information and Product Label (Communicated out in the RMP, PBRER…).

The course will cover:

• The Value and Implementation of an Interdisciplinary Safety Evaluation Framework,
• Scientific Evaluation of Safety Data,
• Aggregate Safety Assessment Planning,
• Assessment of Safety Topics of Interest, and
• Ongoing Aggregate Safety Evaluation.

The course will include:

• 4 weekly 60-minutes life zoom sessions starting in September 2023 (including Q and A)
• Recording of these sessions (live-time access).

Invest in yourself and enrol now into The Aggregate Safety Assessment Course.