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Press Releases

June 28, 2016 Merck Expands Industry-Leading Emprove® Program to Include Filtration and Single-Use Products 
September 14, 2015 Merck Introduces Enhancements to its Emprove® Program of Pharmaceutical Raw Materials to Facilitate Risk Assessment  

White Paper

Satish Kumar Mohanvelu, Marketing Manager, Emprove® Program, MilliporeSigma, Jessica Shea, Global Technical Support, on: The Role of BPOG Extractables Data in the Effective Adoption of Single-Use Systems

Douglas Bowman, Program Manager, Emprove® Program, on: Identifying Appropriate-Quality Raw Materials in an Evolving Regulatory Environment

Janmeet Anant, Regulatory Advocate, on: Risk Assessment for Single-Use Pharmaceutical Manufacturing Systems

Janmeet Anant, Regulatory Advocate, on: Biosimilars: Regulatory Trends and Manufacturing Considerations

Dr. Ulrich Reichert, Head of Pharma & Food Materials, Regulatory Management, on: Elemental Impurities: Implications for Manufacturers of Drug Products, APIs, and Excipients, published in American Pharmaceutical Review

Articles & Interviews

European Pharmaceutical Manufacturing

Heike Michaelis, Director of the Emprove® program, and Frithjof Holtz, Head of Advocacy and Surveillance for Regulatory Management, on: Risky business: Establishing quality risk assessments

PDA Letter

Frithjof Holtz, Head of Advocacy and Surveillance for Regulatory Management, on: Establishing a Formalized Risk Assessment for Excipients

Contributions in “Go Beyond Today’s Biopharma” Blog

The recent survey by the Economist Intelligence Unit asked biopharma execs about their hopes and concerns for the future of the industry. The results showed there was great excitement about the emergence of new markets and novel therapies, but this was tempered by worry over the complex maze of regulatory requirements.

In our “Go Beyond Today’s Biopharma” Blog, Frithjof Holtz, Director of Advocacy and Surveillance, explores the interplay of emerging markets and regulatory harmonization, while Heike Michaelis, Director of the Emprove® Program, shares her thoughts on the industry’s regulatory needs, what companies sometimes miss about compliance, and why regulatory uncertainty can sometimes be a good thing:

Frithjof Holtz: Speaking the Regulatory Language

Heike Michaelis: Finding a New Regulatory Balance in Biopharma