Instructions: Please respond to the two scenarios below in a PowerPoint presentation format 15-20 minutes (20-25 slides) to present the first scenario and 5-10 minutes (6-10 slides) for the second.
Scenario 1: In order to remain compliant with increasingly complex, global regulatory requirements and meet client expectations for efficiency, describe a submission strategy for a phase II clinical trial planned to launch in 15 countries in Asia-Pac, Europe and North America (below are additional details).
Identify the top three risks associated with the submission strategy and how you could mitigate them.
Specifications from the study proposal:
• Study drug, ALMV-001, is a biologic with a novel mechanism of action
• The Phase I Health Volunteer study is currently ongoing with top line results expected by 31 August 2021
• The Sponsor’s target first submission date for the Phase II study is 30 September 2021
• It is a 12-week induction study + 40-week open label
• 3 months of toxicology data is available with long-term tox data expected by end of 2021
• The following countries are proposed for the study:
o North America Canada & USA
o Asia-Pac Australia, India & South Korea
o Eastern Europe Belarus, Russia, Serbia, Ukraine
o Europe Belgium, France, Germany, Hungary, Poland, United Kingdom
Scenario 2: Metrics and key performance indicators can help to measure your team’s success. Identify 2 or 3 key metrics related to regulatory affairs activities and describe how you use these to measure the health of your team/department.