Topic

Ghada Haddad, PhD, is executive director, Global Quality Transformation Global Quality Shared Services & Regulatory Intelligence Merck & Co.

Darshana Patel is an associate director in Global Quality at Merck & Co., Inc.

Articles

The degree of formality in a risk management process should be customized to the organization’s particular needs and the risks involved.

Navigating the Formality Spectrum in ICH Q9(R1)

Lei Lei is senior R&D director of Cutia Therapeutics, Shanghai, China, and he was principal scientist of Shanghai Johnson & Johnson Pharmaceutical Company

FDA’s new guidance on in-vitro permeation test studies published in October 2022 gives technical and statistical requirements for conducting these tests to compare topical generic drugs with their reference products.

In-Vitro Permeation Test Data Analysis with MS Excel as per FDA’s Guidance

Data from environmental monitoring can assist in keeping sterile environments sterile.

Monitoring for Microbes

Chris Spivey is director of Industry Relations and Strategic Partnership, MJH Life Sciences.

Automation can be balanced with operator oversight.

Good Practices for Data Integrity

Mark Lane is vice president of Development Consulting and Scientific Affairs at PharmaLex.

Preparation is essential for regulatory meetings—it not only crystallizes what is needed from the regulators, it helps them better understand the development programme and potential challenges.  

Top 10 Considerations when Meeting with Regulators

Bianca Piachaud-Moustakis is lead writer at Pharmavision, Pharmavision.co.uk.

Changes to PRIME scheme are set to drive greater harmonization across major pharmaceutical markets.

Improvements to EMA’s PRIME Designation Scheme

Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

The UK and EU have negotiated a new draft deal for Britain to re-join the Horizon Europe research programme.

New Deal on the Horizon

Jill Wechsler is Pharmaceutical Technology's Washington Editor, jillwechsler7@gmail.com.

Problems continue despite actions by regulators to better prevent and address drug shortages.

Drug Shortages Continue to Plague FDA and Manufacturers

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

FDA Warning Letters and Form 483s can offer a path to better compliance, says Siegfried Schmitt, vice president, Technical, at Parexel.

Quality Systems