Articles by Sean Milmo - Pharmaceutical Technology

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Articles by Sean Milmo

Extending the Scope of Pharmacovigilance Comes at a Price

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.
Sep 2, 2014

As the pharmacovigilance infrastructure becomes more entrenched in Europe, drug manufacturers are beginning to feel the burden of its high cost.

Collaboration and Innovation in European Medicine Regulation

Aug 1, 2014

The European Union has developed a system for evaluating, approving and monitoring the safety of medicines that has also encouraged innovation.

Regulating the Environmental Impact of Pharmaceuticals

Concern by environmentalists, regulators and manufacturers rises over the environmental impact of pharmaceuticals.
Jun 2, 2014

Concern by environmentalists, regulators and manufacturers rises over the environmental impact of pharmaceuticals.

EU Steps Up Inspection Efforts

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.
May 2, 2014

The rising incidence of medicine defects and shortages stemming from sub-standard manufacturing is forcing Europe to give higher prominence to more effective inspections procedures.

Quality by Design—Bridging the Gap between Concept and Implementation

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.
Apr 2, 2014

As Europe strives to firmly incorporate quality-by-design principles, there are several key issues that still need to be addressed.

European Union Packaging Safety Features Come into Effect

Manufacturers are taking measures to comply with new package safety rules.
Mar 2, 2014

Manufacturers are taking measures to comply with new package safety rules.

EMA Collaborates with HTA Assessment Networks

High technology assessments are having an impact on biosimilars development in Europe.
Feb 2, 2014

High technology assessments are having an impact on biosimilars development in Europe.

Early Communication with Regulators is Essential for SMEs

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.
Jan 2, 2014

With SMEs gaining wider recognition as the powerhouse of research and innovation in Europe, regulatory agencies are urging companies to engage with regulators early in the drug-development process.

Regulation of Biosimilars: A Matter of Variability, Similarity, and Comparability

As the European Union takes a closer look at its biosimilars guidelines, some key issues are proving difficult to resolve.
Dec 2, 2013

The European Union is strengthening its pioneering role in the regulation of biosimilars by further developing the basic rules for determining the levels of compatibility for this group of drugs. There are, however, some key issues that are not easy to resolve, as evident in a recent workshop on biosimilars organized by the European Medicines Agency (EMA).

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FDASIA was signed into law two years ago. Where has the most progress been made in implementation?
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Jill Wechsler Regulatory Watch Jill Wechsler Data Integrity Key to GMP Compliance
Sean Milmo European Regulatory WatchSean MilmoExtending the Scope of Pharmacovigilance Comes at a Price
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