Building Regulatory Preparedness in Latin America: What is the Relevance of Business Continuity Plans for Health Authorities?
New Date and Time Tuesday, January 31, 2023, 10:00–11:30AM ET
*The primary language is English.
Ensuring the continuity of the activities of regulatory authorities is of high relevance, once disruptions in the activities and performance of the health authorities can greatly impact patients' access to products that support the prevention, diagnosis and treatment of diseases. Threats that can affect the continuity of the functionality of regulatory agencies are multiple and of diverse origin - and the development of business continuity plans represents a high-value alternative to mitigate the effects of adverse situations. This promotional webinar will explore concrete examples of measures taken by regulators and industry in times of crisis, formulating ideas that can support Latin America and the Caribbean to address future challenges that influence the normal course of regulatory operations.
Attendees will hear about the role of the International Coalition of Medicines Regulatory Authorities (ICMRA) in global health crisis preparedness, including its work in defining an updated Standard Operating Procedure for Crisis Management. ANVISA will share its role regarding crisis preparedness and management, focusing on tools to ensure business continuity and the communication strategy adopted in response to the COVID-19 emergency. These will be complemented by real-life cases from industry when addressing crisis situations.
Meeting Designed For:
- Benefit-Risk Assessment and Communication
- Clinical Research and Development
- Clinical Operations
- Drug Regulation
- Drug Safety/Pharmacovigilance
- Global Submission/Project Management
- Government Affairs
- Medical and Scientific Affairs
- Medical Communication
- Medical Information
- Medical Product Safety Assessment
- Policy and Intelligence
- Post-Market Studies
- Quality Assurance and Compliance
- Real-World Evidence
- Regulatory Agencies
- Regulatory Affairs, Operations, and Strategy
- Research and Development
- Risk Management, including Risk Evaluation and Mitigation Strategies (REMS)
- Strategic Sourcing/Planning
- Define the importance, structure and scope of business continuity plans for regulatory activities
- Summarize experiences and learnings from regulators that have faced crisis situations
- Formulate alternatives to maintain, recover and/or restore the functions of regulatory authorities after unforeseen disruptions in their activities