Pharma Serialization: Regulations Summary

“By 2018, over 40 countries and more than 75% of global medicine supply will be covered by one or more serialization track and trace regulations”, according to few reports.

Bio/pharma players have to postulate with challenges halting from supply chain security which goes by (product recalls, diversion) counterfeiting and rigidly accurate regulations.Moreover apprehension of safety pertains.

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Centralized Monitoring: A Smarter, Cost- Efficient Approach to Clinical Quality Published in Clinical Leader.

The life sciences industry is faced with the daunting challenge of developing and introducing new drugs and therapies in a quicker and more cost‐effective ma nner. The clinical phase is the most complex part of the drug development process, and it requi res efficient planning, conducting, and monitoring of cl inical trials to achieve the de sired quality and obtain reliable study data that is appropriate for regulatory submission. Clini cal monitoring cost is one of the major costs, accounting for one‐t hird of the overall cost of clinical trial management.

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Risk-based Monitoring: Moving Forward

After issuance of the final guidance document by FDA on Oversight Of Clinical Investigations - A Risk-based Approach to Monitoring, bio pharmaceuticals, medical device companies and CROs are actively embarking on this paradigm shift in clinical research to reap the benefits of risk-based monitoring (RBM). The correct identification of study-specific risks, their sources, categorisation and implementation of risk-based study-specific monitoring strategies, plans are the critical components in implementation of the RBM approach to ensuring high quality, integrity of data, and enhanced human subject protection.

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