MMS Holdings Expert Insights Blog
Experts at MMS share their insights on trending
topics in the pharmaceutical industry.
EMA Policy 0070: Much Awaited Revamp for Clinical Trial Transparency
On May 16th, 2023, EMA conducted a much-awaited webinar to address the phased restart of EMA Policy 0070 after almost five years of suspension. The restart will come into effect in September 2023. The EMA initially introduced the clinical data publication Policy 0070...
The Role of Quality Assurance in Outsourcing: Ensuring Regulatory Compliance and Quality
The role of Quality Assurance (QA) in outsourcing is important for sponsors to reduce business risk, time and effort. In the pharmaceutical industry, vendors can support any aspect of the product's manufacturing, testing, labeling, or distribution. However, the...
5 Reasons to Get Excited About the FDA DSUR Format
Are you working on annual submissions that utilize the current FDA Annual Report format? Are you concerned about the mandatory adoption of the FDA DSUR (development safety update report)? Below are five reasons to embrace the change and place the DSUR at the center of...
FDA REMS Programs, Considerations, and Compliance
The Food and Drug Administration (FDA) Amendments Act of 2007 authorized the FDA to require a Risk Evaluation and Mitigation Strategy (REMS) Program. The REMS program is required if it is determined that specific safety measures are needed to ensure that a drug’s...
Impact of ICH E6(R3) on the Future of Clinical Trials: What You Need to Know
ICH E6(R3), a significant development on the regulatory horizon, is a revision to the International Council for Harmonization's guidelines for Good Clinical Practice and is slated for release in August 2023. As the healthcare industry continues to evolve, it's...
Preparing for a GxP Audit Interview: Tips and Considerations for Auditors and Auditees
When it comes to undergoing a GxP audit interview within the regulated GxP industry, it's important to be well-prepared by understanding the objectives and scope. This is particularly true for clinical research audits, which involve assessing compliance with both...
MMS Named Great Place to Work in the UK as Growth in the Region Doubles
LONDON (18 April 2023) – MMS Holdings, a data-focused contract research organization (CRO), has been named a Great Place to Work-Certified™ organization in the UK. This comes as the number of MMS colleagues based in the UK has doubled in just one year. “We are...
A Comprehensive Guide to Preparing for a Successful Good Laboratory Practice (GLP) Inspection
Good Laboratory Practice (GLP) compliance is an important aspect of research and development, as it creates trust and transparency between stakeholders in the process. When inspections occur, it is important to have all the necessary preparations in order, so the...
New 2023 FDA Guidance on REMS: What’s New?
The Risk Evaluation Mitigation Strategy (REMS) is a drug safety and risk management program established in 2007 by the U.S. Food and Drug Administration (FDA). Under the program, FDA might require manufacturers to implement specific safety measures for certain...