In this podcast we introduce one of Global’s latest ventures, the Global Regulatory Technology Operations (GRTO) team and discuss their newest applications, the Advanced Deficiency Data Management (ADDM) Trend and the Advanced Document Data Management (ADDM) Track applications. Managing regulatory communication and feedback from Competent Authorities or Notified Bodies can be much more than a […]

This episode of Chasing Compliance is for those working on regulatory submissions for in-vitro diagnostic (IVD) medial devices. Today we talk to our resident Performance Evaluation Report (PER) expert, Bethany Hosford provides suggestions on how to improve your EU IVD regulatory submissions including PERs and their associated documents. 2:15 – Brief background of the In vitro Diagnostic Regulation (IVDR) and the Performance Evaluation Report (PER) 3:15 – Items to tackle prior to...

Ready to take your technical writing to the next level, but not sure where to start? Would you like to learn some tips to freshen up your writing approach? In this episode and the next we share more of our favorite tips and tricks for technical writing. Our guide, Jennifer Petrie Signore, PhD has spent years working to become the best and most versatile technical writer possible, and she shares her tips with you. In this episode, we cover a wide range of topics, such as: Document review...

Ready to take your technical writing to the next level, but not sure where to start? Would you like to learn some tips to freshen up your writing approach? In this episode and the next we dive into some of our favorite tips and tricks for technical writing. Our guide through the next two episodes is Jennifer Petrie Signore, PhD. From the start of her graduate training, Jenn was focused on becoming the best and most versatile technical writer she possibly could be. In this short series, Jenn...

This episode is Part 2 of a two-part episode on Abbreviated New Drug Applications (ANDAs). We continue our conversation with our ANDA expert Sandra Kircus. In this part, Sandra provides advice on how to manage ANDA projects, the importance of strong project management, and provides suggestions for project management tools. She also shares her thoughts on how to regulatory leaders can optimize the ANDA writing process and how to optimize the ANDA process fro companies outside of the United...

Chasing Compliance: The Global Regulatory Podcast kicks off season two with a two-part episode on abbreviated new drugs applications (ANDAs). Our guest today, Sandra Kircus, walks us through the basics of ANDA submissions, the ANDA approval process, and common challenges associated with ANDA submission. She also touches on the differences between drug applications (NDAs), traditional ANDAs, and petitioned ANDAs. Following this, we discuss agency communication. Agency communication is often...

Welcome to clinical site selection and evaluation Part 2, where we continue the conversation on optimizing clinical site selection and evaluation. In this episode Linda Peterson and Julie Sheidy share recommendations on how to approach site selection, how to build teams, how to communicate within organizations and across teams, and their approach to site identification. Key takeaways include:  Sites often look to the CRO or Sponsor for expertise and support. A strong CRO will help the...

This is part 1 on our conversation on optimizing clinical site selection and evaluation. In this episode Linda Peterson and Julie Sheidy provide some background on the process of site selection from both the sponsors or clinical research organizations (CROs) perspective and the site’s perspective. Key takeaways include: Site workload is important. Make sure the site has capacity for your study.Ensure the site has access to the patient population and that the population is willing to...

This episode of Chasing Compliance features two first-hand accounts of what it was like to participate in the Global Clinical Evaluation Report (CER) Internship Program. This is Part 3 of our series on the Global CER Internship Program.   Arun and Kristina, two members of the very first cohort of Global CER Interns take us through their experience in the program and provide some insight on how they feel now that they are done. In the first part of the discussion, they address why they...

We are excited to announce the launch of the official Global Regulatory and Consulting Blog. To celebrate the release of the first blog posts we are sharing a conversation Jamie had with two people heavily involved with getting the blog off the ground, Rebecca Lynch and Sarah Schaul. They discuss why Global wanted to start a blog, the core subject matter covered, and what we would like for individuals to get out of the blog. Rebecca, Sarah, and Jamie discuss how we plan to leverage Global’s...

In this episode of Chasing Compliance, Jamie talks with Brandi Quinlin and Rebecca Lynch about generic drugs. The discussion ranges from what a generic drug is to how generic drugs are made, tested, and approved. Brandi and Rebecca also share their knowledge of drug formulation with some “delicious” analogies. Who knew chocolate chip cookies could reveal so much about generics? Lastly, they discuss regulatory requirement for getting a generic to market. Brandi Quinlin holds a master’s...

In this episode of Chasing Compliance, Linda Peterson, Sarah Schaul, and Kari Gibney discuss how to maximize the relationship with your CRO from the Sponsor’s and Site’s perspectives. Each member of the panel shares their thoughts on what makes a CRO great and why communication, flexibility, and teamwork are essential. The show wraps up with some important, but rarely considered, tips for maximizing the relationship with your CRO. Linda Peterson is the VP of Clinical Development at Global....

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...

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 and where...

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...

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...