of FDA and/or EMA Regulations (or relevant local regulations), ICH Guidelines, and GCP governing the conduct of clinical...
regulatory guidance (especially ICH, FDA, and EMA) relevant to clinical and safety data Comprehensive understanding of the drug... (eg, PubMed, DailyMed, FDA and EMA sources and guidelines) for literature and information mining to support document...
Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility...
universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved facility, at approximately 200,000 sq. ft., houses...
EMA and FDA approved facility, at approximately 200,000 sq. ft., houses 10 CGMP manufacturing suites, fill/finish, central...
is close to Washington, DC’s I-270 Technology Corridor, top universities, and government agencies. The Harmans/BWI-1 EMA and FDA approved...
with interacting with medical diagnostic regulatory bodies (e.g. FDA, PMDA, EMA). Experience with Python programing and Python data...
: Ensure that all clinical data management activities are compliant with regulatory requirements, including FDA, EMA... Knowledge: Deep understanding of regulatory standards, including FDA, EMA, and ICH-GCP guidelines...
: Ensure that all clinical data management activities are compliant with regulatory requirements, including FDA, EMA... Knowledge: Deep understanding of regulatory standards, including FDA, EMA, and ICH-GCP guidelines...
of FDA, EMA, ICH, USP, and EP guidelines and regulations associated with the quality control of biological products...