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Session 4: Regulatory Cooperation and Reliance
Session Chair(s)
Justina Molzon, JD, MS
Consumer Services
Consumer Services, United States
This final session of Day One will explore global regulatory trends relevant to biosimilars and how those trends have impacted local or regional regulations. We will continue to address opportunities for recommendations to improve such regulatory cooperation and reliance in other international regions. Specific emphasis will be given to recently published guidances and draft guidance recommendations that are coming from WHO, FDA, International Pharmaceutical Regulators Forum (IPRF), and other LATAM Countries. The following questions will be addressed:
- What are the building blocks of good regulatory practice?
- What is regulatory reliance?
- How do you establish it, measure it, and communicate it?
- What have been the results of regulatory cooperation and reliance in other international regions?
Speaker(s)
WHO GRP Guideline
Daniela I. Decina, MSc
Mapi Group, Canada
Senior Director, Regulatory Affairs, CMC
Hot Topics on Biosimilars
Thomas Schreitmueller, DrSc
F. Hoffmann - La Roche AG, Switzerland
Global Head Regulatory Policy; F. Hoffmann - La Roche Ltd.