Welcome to Chasing Compliance, the Global Regulatory Writing and Consulting podcast where we discuss all aspects of medical device and pharmaceutical regulatory and clinical strategy from bench to bedside. Today we are chatting with Beth Meier and Luke Baker about how to prepare airtight CERs.

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.

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 and completion Software tools for technical writers How to better leverage the tools you use each day When to involve your teammates How to improve the review process

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 shares what she has learned throughout her 15+ years of technical writing experience. In this episode, we cover a wide range of topics, such as: Why you should always follow directions, The role and value of templates and rubrics, The importance of clarity, proper word choice, and succinctness, and How to get unstuck or overcome roadblocks when working on long, complex documents.

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 States referred to as xUS companies. Sandra and Jamie discuss why having strong US agent for xUS companies is important. While this advice is focused on xUS companies, it also rings true for US companies as well.

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 considered one of the most challenging and nuanced aspects Chemistry, Manufacturing, and Controls (CMC) regulatory activities. Sandra discusses this in detail in the second half of the episode, providing her perspective on agency communication and some tips for success. Sandra is a Director in the CMC Division of Global Regulatory Writing and Consulting. Sandra started her career as a chemist in the FDA. After leaving the FDA, Sandra helped several companies establish and maintain regulatory and quality systems. Throughout her 20 year career in the industry, Sandra supported a wide verity of regulatory pathways, however, one of her principal focuses was on CMC-related submissions and submission strategy, including ANDAs. Sandra She holds a B.S. from the University of Montevallo and PhD in Chemistry from UNC Chapel Hill.

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 site through selection, accelerating the process. Build your team around the protocol! Therapeutic area experts are needed on both the CRO/Sponsor side and the site side. Anticipation and foresight are key. An experienced Clinical Research Associate (CRA) or Clinical Research Coordinator (CRC) will deeply review the protocol to identify resourcing gaps and determine how to close those gaps early in the site selection process. They will also take the initiative to bring on internal experts or support staff early in the process to address action items within their expertise. Ensure the site has access to the patient population and that the population is willing to support the study. Make sure the site has the infrastructure to set run the study and identify any mismatches or pain points early. Establishing clear lines of communication and setting out roles and responsibilities will make the evaluation process much faster. Yes, checklists are worth it. Both the Site and the Sponsor/CRO will use them as valuable tools and the process will benefit from their use. Contact advocacy groups – they are involved with local, regional, and national communities. Use epidemiological data or incidence data to find areas where the disease is moderately or highly prevalent.

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 support the study. Make sure the site has the infrastructure to set run the study and identify any mismatches or pain points early. Establishing clear lines of communication and identifying roles and responsibilities early will make the evaluation process much faster. Set realistic expectations. Teaching is much more effective than telling. Take the time to help the site or the CRO understand the process or problem. Use checklists!

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 wanted to get into medical writing and what brought them to Global. Then Arun, Kristina, and Jamie discuss what it was like during the first few weeks and months of the internship, what they learned at each phase, which parts were challenging, and how they feel now after they have completed it. We also discuss what it takes to be successful through the program and Arun and Kristina give their tips for those applying to and entering the program. A more detailed list of the topics covered and when they were covered can be found below. If you would like to learn more or apply for the internship, visit us a www.globalrwc.com and navigate to the careers page. Arun holds a PhD in Bioengineering from Rice University. There he studied cell-cell communication during neural development. He moved onto a post-doctoral fellowship at the University of Pennsylvania where he studied neuroimaging and systems neuroscience. .Kristina started her post-graduate education in dental school at Rutgers. Her passion for science took over and after a year she found herself in the PhD program studying mechanisms of apoptosis or cell death. She continued her basic science training at the University of Florida where she studied the protective effects of vitamin D on the lungs.

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 extensive Chemistry Manufacturing and Controls (CMC), Clinical, and Medical Device expertise to create a new resource for professionals within and outside of regulatory affairs and strategy. They also discuss their favorite upcoming blog topics. The blog can be found at www.globalrwc.com/the-global-blog and within the education center.

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 degree in regulatory affairs and brings years of experience in pharmaceutical development, generic development, pharmaceutical testing, and regulatory compliance. Rebecca Lynch is one of Global’s resident generic drug experts. She has a background in analytical method development and 25 years of experience in the generic pharmaceutical industry.

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. For over a decade, Linda has been leading clinical trials, directing clinical departments, and working with all involved in clinical trials. Sarah Schaul is a Clinical Trial Manager at Global. Sarah started her research career at the bench and transitioned into clinical research several years ago. She has worked on the site side and the sponsor side and now leads clinical studies for Global. Kari Gibney’s primary appointment is at the University of Colorado Anschutz Medical Campus as a Clinical Research Coordinator. For the last 5 years Kari has been a core piece of the clinical research team in the School of Medicine and the Department of Oncology at the University.

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.

In this episode, host Jamie Hijmans discusses GLOBAL's new CER Writing Internship Program with colleagues Jacob Hoffman, DPT, and Juliet Pena, MD. The path to becoming an excellent CER writer can be steep, but the guests discuss how GLOBAL's internship program provides the mentorship and education to help writers reach new professional heights.

In this episode, host Jamie Hijmans discusses GLOBAL's new CER Writing Internship Program with colleagues Dan Sheidy, PhD, and Beth Meier, PhD. The path to becoming an excellent CER writer can be steep, but the guests discuss how GLOBAL's internship program provides the mentorship and education to help writers reach new professional heights.

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]

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. 

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.