
References
- Clinical Trial Facilitation Group CTFG. Q&A document – Reference Safety Information. CTFG November 2017
- Reference Safety Information for Clinical Trials – MHRA Inspectorate. Weblink: https://mhrainspectorate.blog.gov.uk/2016/03/02/reference-safety-information-for-clinical-trials/
- A GUIDELINE ON SUMMARY OF PRODUCT CHARACTERISTICS (SmPC). September 2009. EUROPEAN COMMISSION
- Guidelines for Preparing Core Clinical-Safety Information on Drugs. Second Edition. Report of CIOMS Working Groups III and V. 1999
About Soterius
Soterius is a global industry leader in providing comprehensive drug safety and medical affairs services. We are a customer-focused organization, with a proven commitment to finding solutions for the people it serves, to driving excellence in compliance, and to improving patient outcomes. Soterius has its headquarters in New Jersey and offices in North America, Europe, and Asia. Our team has worked with some of the top global corporations across the world, handling diverse regulations and requirements. We are passionate about finding solutions and providing excellent quality services to our clients. Our quality systems are compliant, we are 24×7 available and always inspection ready.
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