In this webinar...
This webinar will give an overview of an article published in the Journal of Public Health Policy in September 2020 entitled "Registration Pathways to Accelerate Regulatory Assessment of Innovative Medicines in Latin America."
At the conclusion of this webinar, participants should be able to:
- Know which Latin American countries (out of 19 countries assessed) have pathways to accelerate regulatory assessment of innovative medicines
- Identify if these new innovative registration pathways are effective to shorten regulatory review timelines based on the author's experience
- Know which countries require CPP in the context of the available accelerated regulatory pathway
- Know which countries accept Phase 2 studies in the context of the available accelerated regulatory pathway
- Identify opportunities to further improve the current regulatory landscape related to the accelerated regulatory review pathways in Latin America
- The scope of the survey includes most countries in Latin America (19 countries).
- The publication consists of identifying and assessing registration pathways to accelerate regulatory dossiers reviews including practical experiences from authors.
- Ana Padua, Global Regulatory CMC Intelligence Associate Director, EMD Serono