Expert Insights

Developing Treatments for Rare Diseases – Reviewing Recent FDA Draft Guidances

By Amanda Beaster, PhD, et al, June 13, 2019
Every day, new and updated regulatory guidances from the US Food and Drug Administration (FDA), European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA) in Japan, and other global health authorities are reviewed on a monthly basis internally to identify which deliverables are impacted and to determine which processes or trainings need to be created or updated as a result.

Eleven Experts Discuss the Leadership Mindset of SOUL

by Staff writer
SOUL stands for bringing a Sense Of Urgency and Leadership to work each day. The SOUL of MMS comes to life as project work is completed on time and as risks and solutions are identified proactively. At MMS, each colleague takes responsibility for the success of every project.

Part 2: 505(b)(2) NDA – The Importance Early-Stage Planning

by Ben Kaspar, May 23, 2019
The unique aspects of the 505(b)(2) submission structure and label claims are perhaps best illustrated at the pre-IND planning stage. Whereas for a new chemical entity, pre-IND discussion is generally focused on the determination of a safe starting dose in humans, the 505(b)(2) discussion will be focused around unsupported label claims and getting FDA agreement on the plan to address those claims in clinical development.

Part 1: 505(b)(2) NDA – Navigating the Regulatory Pathway

by Ben Kaspar, May 16, 2019
The 505(b)(2) is a New Drug Application (NDA) containing full reports of safety and effectiveness, where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference for use.

FREE DOWNLOAD: Lay Summary Whitepaper

Kasim McLain, et al, May 9, 2019
This whitepaper will explain the ins and outs of lay summary writing, the importance of starting a pilot program, a checklist for lay reviewers, and strategic advice for becoming more transparent.

Being Inclusive, the Open Door Policy, and True Success: A Conversation with Diederik Van Niekerk

by Staff writer, April 11, 2019
In this Expert Insights interview, we sit down with our South African leadership, Diederik Van Niekerk, Operations Manager at MMS in Bloemfontein, South Africa, to discuss his detailed approach for effective team-building, his views on work/life balance, and growth. Diederik’s leadership and excellent insights has strengthened MMS South Africa and he is an award-winning executive business coach in his own right.

PhUSE: Retrospective vs. Proactive Anonymization of Narratives

by PhUSE, March 14, 2019
This White Paper focuses on two approaches to produce anonymized narratives – retrospective and proactive. The retrospective section sheds light on the challenges faced with qualitative methods like redaction and what impact it has on data utility. The second part of this White Paper offers a perspective on proactive anonymization and how to operationalize it.

 

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