Chasing Compliance, presented by Global Regulatory Writing & Consulting, is a podcast focused on regulatory strategy, achieving and maintaining regulatory compliance, and the influence of regulation on healthcare overall. Guests include highly accomplished regulatory professionals, medical writers, scientists, engineers, and clinicians giving their take on some of the most complicated and challenging topics in clinical development.
Chasing Compliance is hosted by Jamie Hijmans, PhD, a physiologist deeply passionate about scientific innovation, maximizing regulatory efficiency, and improving the quality of life for regulatory professionals, manufacturers, and patients. Jamie is a Manager at Global, where he works with medical device and biotech clients to optimize their EU regulatory strategies. Prior to joining Global, he spent over 10 years in academic research, studying all aspects of cardiovascular disease, from endothelial dysfunction to pediatric heart failure, and from bench to bedside.
Chasing Compliance is freely available on most podcast services. If you enjoy the podcast, subscribe to ensure that you never miss an episode, and be sure to leave a review. If you have questions or ideas for future show topics, please send them to email@example.com.
Marysa Mezzetti - Risk Documentation and MDR
Have you considered the impacts of the Medical Device Regulation (MDR) on your current risk documentation and management strategies? You may be wondering, what devices can be grouped together? Should you group your devices at all? How will these changes impact your Clinical Evaluation Report? In this episode of Chasing Compliance, Marysa Mezzetti, a Manager on the Medical Device team, and Jamie discuss how risk management and documentation practices must be considered for each device individually, implications of device lifetime, life cycle, and safety and performance objectives, and changes in the risk documentation language. While there is no clearly defined path forward for manufacturers, this episode provides some guiding principles that will help develop a sound MDR remediation strategy. Marysa ends their conversation with some tips and best practices regarding MDR-related changes to risk documentation. As always, Jamie wraps things up with Favorite Friday.
Basic overview of risk documentation, QMS, and MDD – 2:10 Who is responsible for writing risk documents – 6:45 Initial discussion of MDR – 8:05
New risk documentation considerations for device families - 12:20 MDR, Article 10, ISO 14971, and the Notified Body - 17:30 Changes in language in risk documentation and emphasis on overall risk compared to overall benefit - 22:30 Impact of risk documentation changes on clinical evaluation and Clinical Evaluation Report strategy – 27:20 How the CER writer can help the risk process - 29:00
Marysa’s tips and best practices for achieving and maintaining compliance - 31:15
CER = Clinical Evaluation Report
dFMEA = design failure modes and effects analysis
FMEA = failure modes and effects analysis
MDD = Medical Device Directive
MDR = Medical Device Regulation
PMS = Post Market Surveillance
QMS = Quality Management System
Part 2 - Overview of Global's CER Internship and Stories of Entering Regulatory Writing with Jacob Hoffman and Juliet Peña
Part 1 - Overview of Global's CER Internship and Stories of Entering Regulatory Writing with Beth Meier and Dan Sheidy
Sarra De Valence - Senior Manger of CER Writing on Systematic Literature Search and Screening
On this episode of Chasing Compliance, host Jamie Hijmans and Sr. Manager Sarra De Velance discuss systematic literature search and screening. They discuss the importance of robust literature searches and screening processes and the consequences of poorly constructed search terms. Sarra describes her process and provides tips for developing robust searches. They discuss the pitfalls and benefits of using search operators such as Medical Subject Heading (MeSH) terms and not operators, as well as where to look for help if you get stuck. Sarra also provides insight into surmounting the challenges of literature screening, including developing comprehensive and clear inclusion and exclusion criteria, common errors made during literature screening, and best practices for creating rigorous, reproducible literature screening processes. As always, they wrap up the episode with Favorite Fridays.
Sarra and Jamie cover:
The consequences of suboptimal systematic literature searches [6:03]How search terms are used and methodology for creating robust search terms in the context of the literature review [8:05]Why manual searches don’t work in a regulatory environment [10:42]How poorly constructed search terms influence search results [13:30]Common errors in search term construction [16:57]The value of not quires and the risk of misuse [18:50]MeSH terms - what they are and how to use them [25:20]How to develop search terms and where to get help [29:19]Techniques for combining search terms [36:12]Using adjacencies to search for phrases [39:15]How to structure inclusion and exclusion criteria [43:32]Challenges of and best practices for rigorous and unbiased literature screening [46:47] Use of the “other” exclusion criteria [51:10]Common errors in search screening, including overuse of the find tool [53:29]Sarra’s last two tips for screening [58:20]
John Jolly - Manager of CER Writing Discusses Medical Device Post Market Surveillance (PMS)
In this episode of Chasing Compliance, host Jamie Hijmans sits down with John Jolly, a Manager in Global’s Medical Device Department to discuss medical device post-market surveillance (PMS). Over the course of the episode, John and Jamie discuss John’s path from biomechanical engineer to PMS guru, the value of academic research experience in the world of regulatory affairs, what PMS is and why it matters, and the differences between the United States and European Union. Perhaps most importantly, John discusses what the pending European Union Medical Device Regulation (MDR) means for manufacturers in terms of PMS, and he provides a brief overview of 7 aspects of PMS that are going to be affected by the beefed-up regulations. On the lighter side, John and Jamie wrap up the episode with recurring segment, Favorite Friday Nights. John talks about movie night with his family and how working from home has improved his quality of life.
Carrie Eklund - Senior Manager of CMC
In this episode of Chasing Compliance, host Jamie Hijmans sits down with Carrie Eklund, Senior Manager of Chemistry, Manufacturing, and Controls or CMC at Global. Over the course of the episode, Carrie discusses how her start as a research scientist prepared her for a career in CMC regulatory affairs. A self‑described “lab rat” who loves her job because she gets to “nerd out” every day, Carrie’s passion for science and regulatory affairs is apparent as she discusses her role at Global and how she and her team have used their combined experience to surmount the challenges associated with working as 3rd party CMC writers and consultants. She also discusses her team’s experience with a wide range of regulatory documents, such as, biological licensing applications, investigational new drug applications, drug master files, agency correspondence, biosimilars, first‑in‑class treatments, vaccines, and more. She provides insight on some common mistakes made by CMC writers, tips for navigating challenging regulatory scenarios, and the value of teamwork and a great team culture. On the lighter side, Carrie discusses why she loves working at Global, work in the time of COVID, her ideal Friday night, and how she maintains her work-life balance.