Quality Systems

Articles

Connect with pharmaceutical and healthcare regulatory authorities around the world via this directory.

Regulatory and Standard Setting Organizations

J. Mark Wiggins is owner and compendial consultant with Global Pharmacopoeia Solutions LLC.

Joseph A. Albanese, director of Analytical Strategy and Compliance at Janssen Research and Development, LLC

Monographs are developed based on the submission of information and materials from a company having regulatory approval for the product, and this submission feeds into the pharmacopoeia revision process.

Monograph Development: Why and When to Participate (eBook)

This final article in the series has two purposes: to summarize all the considerations that go into a company’s compendial affairs program and to look ahead at topics that will likely result in further evolution in the pharmacopoeias around the world.

Pharmacopoeia Compliance: Putting It All Together; What Is on the Horizon (eBook)

This article returns to the topic of complying with pharmacopoeial requirements with a case study at the intersection of monograph development and compliance.

A Practical Approach to Pharmacopoeia Compliance (eBook)

The National Institute for Health and Care Excellence (NICE) has issued a positive recommendation for Teva Pharmaceutical’s migraine therapy, Ajovy (fremanezumab).


NICE Issues Positive Recommendation for Teva’s Migraine Therapy

EMA, along with its partners across the European medicines regulatory network, are keeping a close watch on the pharmaceutical supply chains in the European Union as a result of the potential impact of COVID-19.


EU Regulators are Closely Monitoring Potential Impact of COVID-19 on Supply

European Union and national authorities are continuing to work on the prevention and management of nitrosamine impurities in medicines.

European Authorities Continue Work to Prevent and Manage Nitrosamine Impurities

The global safety organization of Novartis is in the process of conducting a comprehensive review of a limited number of cases where patients treated with Beovu (brolucizumab) have experienced severe vision loss, inflammation, and potential retinal vasculitis.


Novartis in Process of Conducting a Comprehensive Product Review of Beovu

Siegfried Schmitt, PhD, is Vice President Technical at Parexel International, Siegfried.Schmitt@parexel.com.

No matter why change may be needed, it is important to comply with all the relevant regulatory requirements, says Siegfried Schmitt, PhD, vice-president, technical, Parexel Consulting.

Embracing Change Management

Sean Milmo is a freelance writer based in Essex, UK.

EU regulators have accelerated their efforts to use the mass of data emerging from the lifecycles of drugs as an effective basis for both the development and control of medicines.


Regulatory/GMP Compliance, Europe