FMD K&L – Upcoming Conferences

by Andrei Shpak

June 13, 2019 The DIA Annual Meeting is approaching quickly! We hope to see you at our booth, # 724, in San Diego, June 24-27. Use our Promo Codes for a discount: VIP19203 for $100 off registration, and HALL19203 for $150 off a day pass. FMD K&L is delighted to be attending PharmaSug 2019, June […]

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Predicine Partners with FMD to Accelerate Biomarker‐driven Clinical Trials and Regulatory Approvals in the U.S. and China

by Andrei Shpak

FMD-Predicine press release. May 30, 2019 Predicine today announced a strategic partnership with FMD to help biopharma companies accelerate biomarker‐driven clinical trials and concurrent New Drug Application (NDA) submissions in the U.S. and China. The collaboration structure allows for global development of novel oncology therapies for biopharmaceutical companies, including global clinical trial support, regulatory support, […]

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Artificial Intelligence for Quantitative Signal Detection Methods in Pharmacovigilance and Drug Safety

by Andrei Shpak

Signal detection and risk management is an important area for pharmaceutical companies for safety surveillance and benefit-risk monitoring of approved products. Marketing Authorization Holders (MAH) are using various signal detection methods and systematic empirical assessments (i.e. quantitative methods) to identify signals.

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A Practical Risk-Based Approach to Computerized System Validation

by Andrei Shpak

Computerized System Validation (CSV) is a process of achieving and maintaining compliance with applicable GxP regulations and fitness for intended use by the adaptation of principles, approaches and life cycle activities within the framework of validation plans and reports & by the application of appropriate operation controls throughout the lifecycle of the system.

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Leverage the Favorable Regulatory Reforms in China to Accelerate Global Drug Development Programs. Watch Recorded Webinar.

by Andrei Shpak

FMD has successfully hosted a webinar titled “Leverage the Favorable Regulatory Reforms in China to Accelerate Global Drug Development Programs“. Dr. Dan Zhang, Executive Chairman of FMD, and Emil Fu, SVP International Integration of FMD, discussed the regulatory reform in China and the strategies biopharma companies can take to make your programs more efficient. In […]

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