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Biosimilars briefing Event Time: 2:00 - 3:00 p.m. ET Event Location: Virtual The National Health Council invites you to join us for a webinar on the latest developments with biosimilars on Monday, June 12 at 2 p.m. This briefing will focus on the value biosimilars hold for patient communities and our health care system.
ASBM Advisory Board Chair Philip Schneider, MS, FASHP, FFIP gave a presentation entitled “Key Factors for Improving Sustainability in Biosimilar Markets”. The presentation reflected the findings from a recent webinar ASBM held on this subject with GaBI Journal. Read the GaBI Journal report of the webinar here.
The webinar largely consisted of summarizing the general requirements under Parts 803, 806 and 820.198, which we do not reproduce here ( but see another of our prior blog posts discussing these requirements and their applicable to LDTs in greater detail; you can also find FDA’s slides from the webinar here ). By Steven J.
NHC Events Provide Connection and Content July 27, 2023 By: Bhriana Smith, Senior Coordinator, Communications The National Health Council (NHC) has brought diverse organizations together to forge consensus and drive patient-centered health policy for more than 100 years.
For example, a pharma company launching a new biosimilar for rheumatoid arthritis can publish a whitepaper detailing clinical comparisons with the branded biologic. Webinars & Virtual Conferences HCPs value expert insights and peer discussions. This is where content marketing campaigns make a difference.
Add to that the competition from generics and biosimilars, and the stakes couldn’t be higher. Tools like telehealth platforms, mobile apps, and digital detailing enable seamless communication with HCPs and patients. Using email, social media, in-person meetings, and webinars to deliver a consistent message across platforms.
Communicate with patients and caregivers-at-home in a simple language Communicate with patients and caregivers-at-home in a very simple manner. which sells sophisticated products using simple communication. I love the way Ogilvy sends automated reminders for their webinars! Do not be myopic.
Communication in this area included on-line videos, webinars, summits, conferences, and international outreach. Recalls, warning letters to online pharmacies, and drug-related import alerts were key tools for OC’s efforts to safeguard the drug supply chain from adulterated products over the prior fiscal year.
FDA offers a flexible approach to achieve this goal, suggesting that some information may be suitable for inclusion on an implant ID card for the patient or caregiver, while other information may be better communicated in a different format (e.g., separate patient labeling).
Model cards are used in the broader AI-industry and may be helpful to communicate information about an AI-enabled device. FDA plans to host a webinar to discuss the Draft Guidance. A Model Card is noted as a means of providing appropriate information in both places. Comments on the Draft AI Guidance are due by April 7, 2025.
While not terribly informative, under the prior administration, FDA held a webinar to outline the requirements of this Stage. The materials from this webinar are still available on FDAs website ( here ). Since the new administration took office, however, the webinar page has been taken down from FDAs website.
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