Articles by Sean Milmo - BioPharm International



Articles by Sean Milmo

Sean Milmo

Extending the Scope of Pharmacovigilance Comes at a Price
September 1, 2014

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

EU Steps Up Inspection Efforts
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
April 1, 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
March 1, 2014

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

EMA Collaborates with HTA Assessment Networks
February 1, 2014

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

Early Communication with Regulators is Essential for SMEs
January 1, 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
December 1, 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).

European Union Introduces GMPs for Excipients
November 1, 2013

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.

EU Raises API Standards: A Curse in Disguise?
September 1, 2013

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?



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