Strategy for submission of the Clinical Trials; Metrics -- 2

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.

Kemahiran: Penyelidikan, Powerpoint

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Tentang Majikan:
( 1 ulasan ) Magurele, India

ID Projek: #30038364

10 pekerja bebas membida secara purata €74 untuk pekerjaan ini


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