and qualification of new mechanical systems, ensuring they meet all GMP, FDA, and EMA requirements. Implement continuous improvement... and Biomedical Laboratory (BMBL) guidelines Knowledgeable in FDA, EMA, GxP and ICH regulatory requirements. Good working knowledge...
for each member. o Assess and evaluate member’s initial needs through the EMA screening tool. o Educate members about Case...-site programs to ensure quality standards are met. o Abide by NASW code of ethics, HIPPA and Atlanta EMA Case Management...
methodologies Extensive knowledge of GMP, ICH and FDA/EMA regulations Excellent technical writing skills including but not limited...
methodologies Extensive knowledge of GMP, ICH and FDA/EMA regulations Excellent technical writing skills including but not limited...
for clinical trial disclosure rules (EMA Policy 0070, Health Canada, USFDA) such as FDAAA 801, EudraCT for Data Sharing. Subject...
regulations, guidelines, and/or specifications (eg, FDA, EMA, ICH, eCTD, IDMP, UDI, etc). Knowledge and practical experience in...
and external contract test lab operations is preferred. · Comprehensive knowledge of FDA and EMA regulations and experience in...
into the Central Nervous System (CNS penetrant) that has received Orphan Medicinal Product Designation from the EMA... Authorization Application (MAA) has been validated and is currently being reviewed by the EMA’s Committee for Medicinal Products...
with participants, including collect anthropometric, survey data, ecological momentary assessment (EMA) data, video-recorded meals...
to other staff members. Scan appropriate documents into EMA. Verify insurance benefits and eligibility. Collect outstanding...