redaction of clinical documents in accordance with EMA Policy 0070, Health Canada Public Release of Clinical Information (PRCI...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
cure. To date, over 43 therapies conducted at START locations have obtained FDA/EMA approval. Incredibly, while Academic...
of all interactions with patients via EMA. 5. Speaks with patients or patient representatives to give biopsy and lab results. 6. Obtains...
. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing. Must be action-oriented and proficient...
of relevant cGMP experience. Experience in FDA/EMA regulations in biopharmaceuticals or cell therapy manufacturing is preferred...
agencies such as FDA (including advisory committees), EMA, CDC, AHRQ, and WHO; and at scientific conferences. Maintains...
(preferred) Thorough knowledge of all related systems including EMA ModMed & eClinicalWorks preferred Maintain strict... confidentiality and adhere to all HIPAA guidelines Thorough knowledge of all related systems including EMA ModMed & eClinicalWorks...
, and biotechnology industry is required. Solid understanding of relevant regulations and guidelines (e.g., FDA, EMA). Demonstrated...
development process, including strong knowledge of international standards (GCP/ICH), health authorities (FDA/EMA), local/National...