CMC Group’s Post

10 years ago today Running On Air came into being. After my TV interview the day before, and being a patient speaker at a drug company's annual meeting and speaking at the FDA the previous month, showed me I could make a difference. Running On Air has been making a difference for 10 years now, and we're only just beginning. View our 10th Anniversary Impact Report here: https://lnkd.in/gk6Y8zy5

▪ It was great to catch up with old friends and colleagues, seeing them now in these positions of influence, hugely successful careers, taking ownership, protecting our two-legged and four-legged public. ▪ It was great to connect with FDA in this relaxed setting - instead of during an inspection or regulatory meeting! 😉 ▪ It was also great to meet folks for the first time! The networking opportunities were great, though I did miss quite a few of you! A few take-aways: 🔹 Basic, fundamental GMP issues continue to be seen by FDA across the industry, despite the tools, technology, resources, policy, guidance documents, history of observations, warning letters and enforcement, training, industry groups. 🔹 Bare feet in an ISO-classified suite?!?! 🔹 FDA’s Top Ten Issues cited in 483s have not really changed over 20+ years; rankings have shifted up or down, but it is still the same things 🔹 Similarly, DI (data integrity) is not a new concept. As Dr. Cavazonni said, “Get away from paper.” 🔹 “Reading an SOP is not training” – Alonza Cruse 🔹 “The battle is won and lost at the Supervisor level” – Kevin O’Donnell, (HPRA) 🔹 Have we forgotten about the patient? Have we forgotten who the patient is? Do we not realize we are The Patient? 🔹 “Cost of Quality” Why do we use this term? Why don’t we ever speak of the Cost of HR? The Cost of Supply Chain? of Technical Services? 🔹 Leadership sets the tone: it is the determiner of success. 🔹 Leadership is responsible for issues – whether they know it, or not. 🔹 Training, training, training. Real, intentional, training. Designing your org to be effective over the product life cycle should be your goal, not just for the next quarter’s results. Isn’t there a company out there that can help with this? 🔷 Eliquent – from thought to finish 🔷 Christie Bielinski; Karin Baer; Ileana Barreto-Pettit; Linda Evans O'connor;William (Al) Kentrup; Gerard (Jerry) Greco; Donald Ashley; Grace McNally ; Barbara Clendenen; Carmen C. Araujo; Elaine Shannon; Magaly Aham, MSc, RAC-US; Christina M. Mazzella; Domenic Veneziano; Sumaiya Reza; Zhenzhen Liu; Arlene Wolny; Arie Menachem; Saundrea Munroe; Jerome Chal; Maria McCaffrey; Cathy Burgess; Beth Weinman; Greg Levine ; Darrin Schellin; Brendan Carroll; Ben Wolf; Anthony Fanucci, PharmD, JD; Quality & Regulatory Network; Alonza Cruse; Michelle Toro, ASQ CQA, CSQP; Judy Zdanowicz; ELIQUENT Life Sciences; Eliquent Japan, Inc; Eli Shani; Ori Landau; Kimberly Garko; Jenna McCarthy

Transparently measuring and acting on your customers' experience is essential for a long-term vision !

learn more about cannabis regulations and the industry in Massachusetts. great job, Comms!

Honoring the brave souls who sacrificed for our freedom. 🌺 Today, we remember and thank those who served. Lest we forget. #remembranceday #rxconnectspecialtypharmacy #rxconnect #specialtypharmacy #pharmacylife #lestweneverforget #lestweforget2024 #pharmacy #rxconnectspecialtypharmacy #rxconnectcares #november11 #RemembranceDay2024 #November2024

Excited to be at this year’s RAPS Convergence! If you’re attending, be sure to schedule time with our team of regulatory experts to discover how ELIQUENT simplifies regulatory complexity and drives success for their clients. Looking forward to engaging discussions on the latest industry trends and innovations. #RegulatoryAffairs #RAPSConvergence #LifeSciences #ELIQUENT #RegulatoryExcellence #Compliance #ClarityInComplexity

The Ducks are number one! No one really thought that this could happen. 🦆 They had been close before when part of the Pac12 conference 🦆 They were now in the BIG10 conference, competing with Ohio State, Michigan and other powerhouse teams 🦆 Their chance for success this year was around 50% in some people’s minds The Head Coach believed in the team and was clear on their plan 🦆 Show everyone that they belonged in this conference 🦆 Show up and focus on each game as a team 🦆 Learn from the game they just played to make the next one better 🦆 Play for the championship The plan was a success! The Ducks 🏆 Are ranked number one in college football, with a 13-0 season 🏆 Won the Big10 conference 🏆 Are in the quarterfinals for the College Football Playoffs That’s nice, but what does this have to do with drug development? In drug development, like college football, companies that have a new drug they want to develop need to have a plan for success. They need to 🏆 Show that the drug is safe and that it works 🏆 Understand the plan and show up as a team 🏆 Adjust the plan based on data 🏆 Determine how to make the drug successful commercially As the Head Coaches (Chief Medical Officers, Heads of R&D, Pharma CEO’s, etc), do you have a plans that will get you to the championship (commercialization) and beyond? Let's connect! ***************************************************************************** Hi! My name is Wendi Carroll and I partner with biopharma companies to transform today’s trials into tomorrow’s therapies. Click on “Book an Appointment” ☝ and let’s have a conversation. Picture courtesy of Ilene Morrisette

Registration is now open for CLEAR’s recently re-designed 3rd Tier NCIT program, "Drug Diversion Investigations," which will be offered March 19-27, 2025. This program provides a comprehensive overview of identifying, addressing, and preventing drug diversion in healthcare settings. The course covers regulatory frameworks, investigative techniques, and collaborative approaches necessary to combat drug diversion effectively. Learn more- https://lnkd.in/ecCCTFDJ

🚀 Excited to announce that the Cognizant team will be participating and presenting at the upcoming EU World Drug Safety Congress in Amsterdam this October! 🎉 We will discuss two key topics that are crucial for the future of pharmacovigilance: 1️⃣ Why It’s Time to Bring Real-World Data into Pharmacovigilance to Enhance Patient Safety: We’ll explore the growing importance of incorporating real-world data into our safety practices, and why the industry must urgently adopt this approach to ensure better outcomes for patients. 2️⃣ Leveling the Playing Field in Pharmacovigilance for Mid-Sized and Small Pharma Organizations in 2024: This session will address the unique challenges smaller organizations face when trying to adopt automation and innovation due to cost and complexity. We'll delve into how a Full Service Provider (FSP) model can democratize access to these critical advancements. These discussions will cover both the strategic and operational aspects of pharmacovigilance, underscoring the need for industry-wide access to innovation and the critical role of real-world data in enhancing patient safety. Looking forward to engaging with fellow industry leaders and driving these conversations forward!

🎄 LDTs for the Holidays? Well, sort of... 🎄 Association for Diagnostics & Laboratory Medicine just launched an accredited online course on LDTs and the upcoming changes to FDA oversight. The course covers everything you need: planned regulatory updates, what to expect, and how to prepare for what's ahead. ✨ And here's the best part: it's FREE for ADLM members! ✨ Wishing everyone a happy holiday season. https://lnkd.in/gFvrzNME