ISPE Boston Area Chapter的动态

Why ISPE: The International Society for Pharmaceutical Engineering offers a wealth of information and invaluable resources for professionals in the pharmaceutical healthcare industry. I've come to appreciate the unlimited purposes that ISPE serves. ISPE plays a pivotal role in fostering development, collaboration, knowledge exchange, and innovations. ISPE ISPE Boston Area Chapter

? 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

?? During Roundtables I and II at our “Bridging the Gap: The New Pan-European Observatory as a Catalyst for EHDS implementation” event last 26 September, experts from EU HTA agencies, researchers, and patient representatives came together to discuss how standardized patient data can revolutionize health research and policymaking. These insightful conversations explored how the H2O Pan-European Observatory (PEO) can support the European Health Data Space (#EHDS) legislation and bridge the gap between stakeholders. ?? Want to find out the key takeaways? Watch the full panel discussion now and see how we’re shaping the future of health data in Europe. ?????? ?? https://lnkd.in/eub25BkX #HealthData #H2O #PEO #patientoutcomes #digitalhealth EFPIA - European Federation of Pharmaceutical Industries and Associations; Innovative Health Initiative (IHI); European Patients' Forum, Trial Nation, JDRF International, Teamit ???

Are you in the Life Sciences Eco-system and in the GTA? Here is an event to look into!

Join me for an insightful panel discussion at the BIO International Convention in San Diego on June 5. Our session, "Evolution of the IRA: A New-Year, a Potential New Administration, Yet Tackling the Same Access and Affordability Challenges," will feature expert panelists like William Roth, Gerry Gleeson, Albert Thigpen, and William Sarraille. They will demystify how IRA will change the landscape for emerging pharmaceutical companies and put recent developments in plain language. Don't miss out on this opportunity to stay ahead of the curve in the ever-changing world of drug pricing and Medicare negotiation. #BIO2024 #IRA #drugpricing #medicarenegotiation

Great to be in included in this CPHI NA roundup article, highlighting insights from top Pharma industry leaders. Torbay Pharma CEO Emma Rooth shared her valuable perspectives on our plans to strengthen our presence in the US market as a contract manufacturer. The interview conducted at the event offers a comprehensive look into our CEO's vision and the strategic steps we are taking to expand further into the US. Gain valuable insights to our exciting journey ahead by reading the article... #pharmainterviews #industryinsights #torbaypharma

?? Looking back to World Drug Safety Congress Europe that took place now three weeks ago and reflecting on the thought provoking discussions and networking that took place. Check out the highlights video and the post-event report below to hear more about this year's congress.

How can we help you? For example, is there one #MES issue you, your team, and your organization are tired of talking about? Stop by Exhibit W226 at ISPE Boston, and let’s talk about what you’re tired of talking about. #ISPEBoston?#ISPE?#Biotechnology?#Pharma #LifeSciences

Excited to be representing Rho at #octeastcoast this year! As the clinical trial landscape transforms, I'm eager to showcase Rho's strategic solutions that can chart the course for your successful drug development journey. Are you attending OCT East Coast? Let's connect and discuss how Rho's expertise can help you navigate the complexities of clinical trials and achieve your development goals faster. Comment below or send me a DM!