BIO Professional Development
Through a curated network of education alliance partners, BIO offers industry professionals executive training and development resources for accelerating career growth
FDA Risk Communication
Effectively communicate risk information, such as the definition and execution of fair balance in promotional materials. Learn common terms such as Brief Summary, Boxed Warning, Important Safety Information, Adverse Event reporting - plus enforcement letters illustrating the application of these requirements.
Takeaways
The communication of risk information is critical for promotional compliance
There are specific ways to communicate risk: Fair Balance, Brief Summary, Boxed Warning, Important Safety Information (ISI) and Adverse event (AE) reporting
Enforcement letters illustrate the application of risk communication requirements
What are the FDA requirements for prescription drug advertising versus promotional labeling? Can secondary endpoints be used in product promotion? Learn the FDA regs and more.
A first-time CEO's playbook to empower you to navigate the commercialization journey effectively.
Explore drug approval process for small molecules & biologics: regulatory bodies, application process, preclinical to clinical studies, final approval.
Explore cGMP benefits & challenges. Learn about pillar requirements: QMS, Premises, Personnel, Materials, Documents, Validation. Understand audits & remediations with case studies.
Learn about AAV viral vector platforms, Triple Transient Transfection, upstream & downstream bioprocessing, packaging, & CMC regulatory aspects.