AMCP Format for Formulary Dossiers Series – Use of Companion Diagnostic Tests

In the Special Content Considerations section of the AMCP Format for Formulary Dossiers, the third topic is Companion Diagnostic Tests. There are many ways to define companion diagnostic tests (CDTs), and manufacturers may or may not have a relationship with the CDTs associated with their product, which can affect how they proceed with their dossier.

Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with your dossier, let us know: 877-477-0977 or https://medcommunications.com/contact-us/

#AMCP #dossierwriting #managedcare

AMCP Format for Formulary Dossiers Series – Use for Clinical Laboratory Tests and Medical Devices

In the Special Content Considerations section of the AMCP Format for Formulary Dossiers, the second topic is Dossier for Clinical Laboratory Tests and Medical Devices. While the AMCP format can be used for medical devices, “it is recommended that medical devices that are most directly related to the use of a drug are most relevant and applicable for the AMCP Format.” Indeed, the AMCP Format encourages medical devices to create dossiers, keeping in mind that some areas of the format may not be applicable for medical devices. Further, the FDA’s Use of Real-world Evidence to Support Regulatory Decision-making for Medical Devices may be helpful in determining what types of real-world evidence and data to include.

Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with your medical device dossier, let us know: 877-477-0977 or https://medcommunications.com/contact-us/

#AMCP #dossierwriting #managedcare

AMCP Format for Formulary Dossiers Series – Inclusion of Comparative Effectiveness Research

In the Special Content Considerations section of the AMCP Format for Formulary Dossiers, the first topic is Comparative Effectiveness Research. While most manufacturers provide evidence from randomized, controlled trials as an essential step in the product’s life cycle, It is recommended that manufacturers provide evidence from comparative effectiveness research (CER) as soon as it’s available.

Short intro: AMCP Format v4.1 Posts_CER

Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with adjusting your dossiers to meet the new guidance, let us know: 877-477-0977 or https://medcommunications.com/contact-us/

#AMCP #dossierwriting #managedcare

Remote Working

Med Communications has a high percentage of workers who normally work from their own home offices. We believe this allows us to get the best people for the job and offers the benefit of work-life balance to our employees. At this time, close to 100% of Med Comm staff is now working at home, and we have continued to provide seamless support to our clients while ensuring the safety of our staff during this difficult time.

So, how do we do it? As far as tools, all of our employees have laptops, access to essential files on our company shared servers, and headsets and RingCentral for calls and meetings. But more importantly, we hire talented, smart people; we train them well and often; and we over-communicate to make sure everyone is on the same page (lots of 1-on-1s, team meetings, and company meetings).

If you are new to remote working, there are many webinars to assist you and your teams in adjusting to the new (and hopefully short-lived) normal. A well-known offering is from LinkedIn Learning, which is offering a free learning path of sessions to get you and your teams comfortable with working remotely: https://www.linkedin.com/learning/paths/remote-working-setting-yourself-and-your-teams-up-for-success

If you need any assistance or advice, contact us: 877-477-0977 or https://medcommunications.com/contact-us/

We are here for you

During these complex and trying times, we are here for you, the client, the patient, and each other. If your company is in need of additional support in medical call center, medical writing, or pharmacovigilance, please contact us to discuss how we can support you.

Med Communications will continue to remain open, ensuring uninterrupted support to our biopharmaceutical company partners who are working diligently to develop treatments all around the globe.

In our family of team members, our first priority is the well-being of our employees, our clients, and customers that we interact with every day. Communication is vital at this point, and we are constantly monitoring the situation as it evolves, making appropriate changes to our business as needed, while providing you timely updates as the situation unfolds.

With over 15 years of remote, work-from-home experience, we are very familiar with what it takes to successfully support and provide remote coverage. We continue to work diligently each day to assist our partners in implementing this approach without disruptions. Our goal is to continue to deliver the highest caliber of service in this unprecedented time.

Thank you for being part of our mission. We are committed to keeping our staff, you, and the community safe. If you have questions or specific needs, please contact us: 877-477-0977 or https://medcommunications.com/contact-us/

Need High-quality, Timely, and Accurate Scientific Information?

At Med Communications, we specialize in presenting high-quality, timely, and accurate scientific information, so we appreciate getting facts from scientific experts. If you’re looking for high-quality and accurate scientific information about the current state of COVID-19, we’ve assembled some resources:

If you need help launching a COVID-19 product, please contact us: 877-477-0977 or https://medcommunications.com/contact-us/

DIA Medical Affairs and Scientific Communications Forum

The DIA Medical Affairs and Scientific Communications Forum has been moved to May 6-7, 2020 and will be a virtual event, with both speakers and attendees participating remotely via a digital platform. But the preconference Medical Communications Primer: Fundamentals of Medical Communication will still be taking place on Sunday, March 22. Our Director of Medical Communications, Ellen Whipple, will be participating as an instructor as she has for many years. There’s still time to register for the main conference, and Med Communications will be there.

If you can’t make it to DIA MASC and need an Excellence in Medical Affairs Workshop for your team, please contact us: 877-477-0977 or https://medcommunications.com/contact-us/

#DIAMASC #MedComm #medicalaffairs

DIA Medical Affairs and Scientific Communications Forum

Are you attending the DIA Medical Affairs and Scientific Communications Forum next week? You’ve probably heard it’s gone virtual, but for our Director of Medical Communications, Ellen Whipple, the show must go on!

As she has for many years, she will participate as an instructor for the Medical Communications Primer: Fundamentals of Medical Communication during the preconference sessions on Sunday, March 22. She will also be part of a session called A Whole New World: Real World Evidence (RWE) on March 24 (9:10 – 10:25 am PT /12:10 – 1:25 pm ET) with Donna Booth.

You can still register for the conference to participate virtually in these and other sessions: https://www.diaglobal.org/en/cart

If you can’t make it to DIA MASC and need an Excellence in Medical Affairs Workshop for your team, please contact us: 877-477-0977 or https://medcommunications.com/contact-us/

#DIAMASC #MedComm #RWE

AMCP Format for Formulary Dossiers Series – Table of Highlights for Unapproved Products

The formats for Unapproved Product and Unapproved Use Dossiers are new with the latest AMCP Format for Formulary Dossiers. Because manufacturers cannot make claims about an unapproved product or use, the Unapproved Product Sections Dossiers have a Highlights and Overview section instead of an Executive Summary detailing the clinical and economic value of the product, The recommended length of the Highlights and Overview section is 2 pages (4 pages max), and it is recommended that much of the information be presented in a Table Of Highlights. It is acknowledged that much of this information may not be available yet, but if it is, it should be provided, and if it’s later available, the dossier should be updated with it.

Check back for more information on changes in the new AMCP Format for Formulary Submissions. If you need any assistance with adjusting your dossiers to meet the new guidance, let us know: 877-477-0977 or https://medcommunications.com/contact-us/

#AMCP #dossierwriting #managedcare