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The podcast currently has 18 episodes available.
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 beginning to write PER
4:15 – Bethany’s recommendation for starting the PER process
6:30 – Tips for finding clinical data or addressing gaps for challenging IVDs. Bethany answers the question, what do you do if you device is mentioned in several articles, but it isn’t a focus?
9:15 – Do you need to consider your audience when preparing a PER? If yes, how should you do that?
10:30 – What is the best approach for reviewing and summarizing data? Should it be done piecemeal or holistically.
12:00 – Tips for writing associated documents such as the Analytical Performance Report (APR), Scientific Validity Report (SVR), and Clinical Performance Report (CPR).
14:10 – What is required to determine scientific and clinical validity in the case of a companion diagnostic (CDx) or other IVD? Where is this information found? BRCA – Gene which is highly associated with the development of breast cancer
18:00 – When is enough data enough? How do you know you have enough clinical data? What if you don’t have clinical data, what should you do?
20:45 – Bethany’s tips for preparing to write a PER. Key takeaways:
24:45 – What to do if you find you are missing data or have data gaps during the writing process.
28:45 – What should you do if you don’t fully understand the device you are working on or how to best summarize clinical or analytical data?
30:15 – Summary of topics discussed up to this point and Bethany’s tips for staying organized throughout the PER writing process.
33:45 – Generally, how long does it take to write a PER? What are your tips for pacing?
35:15 – Bethany’s tips for finalizing a PER.
40:00 – What is the value of templates in the PER writing 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 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:
1:30 – Recap of last episode.
2:30 – What is Jenn’s process for finishing a document.
5:15 – How to make Microsoft Word work for you and speed up your writing process. Jenn discusses tools within word which help improve the writing process, such as:
9:45 – Other types of software which may help your writing process, such as:
17:30 – Jenn provides her tips for finalizing documents including how to conduct final editing and revision activities. In summary:
22:00 – Review as a team effort: tips for leveraging teammates and colleagues. When is it time to hand a document over? When is it appropriate to reach out for feedback?
31:45 – Final thoughts, summary, and wrap-up
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:
We cover a lot of information in this episode. If you miss something, we’ve summarized the key points below.
2:00 – Jennifer’s provides some background on her technical and scientific writing training and experience. Jamie and Jenn briefly discuss the importance of writing quality and skill in the technical disciplines and options for training.
10:00 – Are there any general misconceptions or mistakes you would like to address right out of the gate?
13:25 – Starting the process: how to use templates and instructions to create a strong foundation. Use the template to guide your writing. Make sure you follow the instructions and providing the information the reader is looking for.
19:25 – How to know how much detail to include? When is it time to “go down the rabbit hole?” When is it appropriate to provide a high-level summary? Look for rubrics and previous work. Don’t hesitate to reach out to the client or the audience.
29:10 – The importance of clarity in technical writing. Tips and tricks for improving clarity.
37:40 – Jennifer’s tips for getting unstuck or moving through challenging sections. Leave yourself landmarks.
41:00 – Overall episode summary.
44:00 – What are we going to cover in part 2?
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.
2:30 – Tips for general approach to writing ANDAs
5:40 – Tips for the ANDA writing process
8:00 – Software for Program Management
10:30 – Proportion of applications from US companies and outside or xUS companies. Implications for xUS companies and role of US agents.
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.
2:05 – ANDA Basics
5:05 – What’s the difference between an NDA and ANDA? Sandra provides additional Background on ANDAs.
9:50 – In the case where two companies are simultaneous developing a drug, can one company file an ANDA soon after the other receives approval on a NDA?
12:05 – What are petitioned ANDAs?
15:35 – What does the ANDA approval process involve? What can one expect?
18:55 – Sandra provides several tips for agency communication.
20:15 Tips for 1st time ANDA Submissions
24:15 Communication with the FDA
30:10 – Sandra’s first tips on improving the ANDA preparation and submission process. To be continued in Part 2.
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:
3:00 – How can the site and sponsor work together to accelerate site selection?
5:15 – Julie describes the traits, skills, and characteristics of a “dream team” from CRO or Sponsor perspective and from the site’s perspective.
8:45 – In the event that a CRO or Sponsor identifies a lack of resources at a particular site, is there an advantage to the CRO or Sponsor supplementing those resources?
10:50 – The importance of strong communication within and between the CRO and site “dream teams.”
14:15 – Tips for maintaining a good working relationship and culture through turnover or staffing changes.
16:30 – Best practices for site identification and site selection in the case of rare disease trials and/or common chronic disease trials.
19:15 – How do you address potential site-related bias or the impact of advanced expertise when considering major center or world-class research institutions? How do you ensure the findings are applicable to all care settings if you are conduct research at elite institutions?
20:15 – Can or should sites advocate for altering a protocol or research question to better fit the population or their specific patient population?
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:
3:30 – What is the site selection process and what are sponsors looking for?
5:50 – How do you put together a site feasibility questionnaire and where do sponsors begin the selection process?
9:30 – What are the most rate-limiting steps of site selection?
14:30 – What happens if a site does not have the facilities or expertise you need to complete the study? Is it the sponsor’s responsibility or the site’s responsibility to secure that functionality or expertise?
16:25 – Recommendations for what to look for in a clinical site. How do sites evaluate studies they are bringing in?
19:00 – Why it is important to evaluate the community around the site during site selection and do sites search for studies?
20:00 – How do sites facilitate site selection and qualification?
22:00 – A protocol-based workload estimation tool.
24:30 – How do sponsors evaluate how busy sites are? Is it realistic for sponsors to try to evaluate sites workloads during site selection?
28:10 – Julie provides recommendations on how the sponsor or CRO can help with site selection from the site’s perspective.
32:30 – Tips for staying organized and productive during site selection, evaluation, and study startup.
35:00 – How can the sponsor motivate sites to move things forward?
Abbreviations:
CRO = Clinical Research Organization
IRB = Institutional Review Board
CRC = Clinical Research Coordinator
CRA = Clinical Research Associate
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.
2:30 – How Arun and Kristina got into Medical Writing
6:10 – What was the first week of the program like
9:30 – Was it challenging to work remotely
11:00 – How did you feel during the first few months of the internship?
13:00 – Do you feel as though you use the skills you learned in the internship
15:30 – Kristina and Arun’s thoughts on how they were evaluated and challenges within the program.
17:40 – What were the following months like? When were you writing your own CERs?
18:50 – Is writing a CER like writing an academic paper?
21:10 – How do you feel about the progression and environment. Was the internship challenging?
22:30 – Do you recommend the internship? If so, who should apply?
26:30 – What are the characteristics or skills of the ideal CER candidate.
28:45 – What tips would you give Internship candidates?
29:45 – Now that you’ve completed the internship how do you feel about your future? Do you feel as though you have the necessary experience?
31:30 – Favorite Fridays.
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.
2:25 – Why did Global start a blog?
4:30 – Details on blog post themes, length, and frequency
7:40 – Clinical Aspects of the GRWC Blog
12:10 – What can readers expect to get out of the blog
19:30 – Blog topics we are all excited about
The podcast currently has 18 episodes available.