Articles by Sean Milmo - Pharmaceutical Technology

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Articles by Sean Milmo

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).

European Union Introduces GMPs for Excipients

Regulators hope new standards will stop illegal drug imports, but manufacturers fear they may stifle innovation.
Nov 2, 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?

The aim of the European Falsified Medicines Directive is to improve the quality of imported APIs, but does the pain now outweigh the gain?
Sep 2, 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?

Seeking Harmonization in Nanomedicines Regulatory Framework

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.
Aug 2, 2013

Nanomedicines have been authorized by European licensing agencies for more than 30 years but are still posing regulatory difficulties.

EU Battles Medicine Shortages

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.
Jul 2, 2013

European governments are under pressure to take regulatory action, but solving the problem of medicine shortages is not as straightforward as it seems.

A Lifecycle Approach to Process Validation

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.
Jun 2, 2013

A science- and risk-based approach to verify and demonstrate that a process operating within predefined specified parameters consistently produces material that meets all its critical quality attributes.

Should Regulation of Combination Products Become More Centralized in Europe?

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.
May 2, 2013

While there are those who want combination products to be controlled by a centralized pharmaceutical-type approval system, the majority of the medical technology industry wants to retain a decentralized device-focused approach.

Advancing QbD in the EU

The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.
Apr 2, 2013

The European Union authorities are stepping up their efforts to incorporate quality-by-design principles into their regulations and guidelines.

Europe and the United States to Negotiate a Free-Trade Agreement

Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.
Mar 2, 2013

Discussions are underway as the pharmaceutical sector calls for greater consistency in the global monitoring of GMP compliance and quality testing of APIs and finished medicines.

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Jim Miller Outsourcing Outlook Jim MillerCMO Industry Thins Out
Cynthia Challener, PhD Ingredients Insider Cynthia ChallenerFluorination Remains Key Challenge in API Synthesis
Marilyn E. Morris Guest EditorialMarilyn E. MorrisBolstering Graduate Education and Research Programs
Jill Wechsler Regulatory Watch Jill Wechsler Biopharma Manufacturers Respond to Ebola Crisis
Sean Milmo European Regulatory WatchSean MilmoHarmonizing Marketing Approval of Generic Drugs in Europe
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