ISPE

SEPTEMBER 8, 2022

The Next Horizon for Therapy Innovations. iSpeak Blog. The Next Horizon for Therapy Innovations. At the 2022 ISPE Annual Meeting & Expo , we devoted one content area, titled "Therapy Innovations," with a focus on the new and unprecedented developments in therapy methods. Trudy Patterson. Thu, 09/08/2022 - 13:05.

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Packaging FDA 93

ISPE

AUGUST 1, 2023

A Member’s Guide to the 2023 ISPE Annual Meeting & Expo Trudy Patterson Tue, 08/01/2023 - 13:51 iSpeak Blog iSpeak A Member’s Guide to the 2023 ISPE Annual Meeting & Expo Edyna Miguez 1 August 2023 The 2023 ISPE Annual Meeting & Expo is just around the corner, taking place at Mandalay Bay in Las Vegas, NV from the 15th to the 18th of October 2023.

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Blog: Ask a Student Pharmacist

DECEMBER 12, 2023

BE ME: Being Equipped for My Excellence eomizowh Tue, 12/12/2023 - 14:44 BE ME: Being Equipped for My Excellence is a program designed for students from under-represented backgrounds. We will embrace our college values of diversity and inclusion; integrity; excellence; joy; curiosity, creativity and innovation during the BE ME program!

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DiversifyRx

AUGUST 18, 2023

Guest Blog by DiversifyRx CRO, Heather Haro In a constantly evolving independent pharmacy landscape, staying up-to-date with the latest products, services, and strategies is vital for pharmacy owners. Diversity: Diversity is a fantastic way to gain new patients and an excellent way to speak to your patients already walking through your door.

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Independent Pharmacies Packaging Patient Care Immunization 52

ISPE

SEPTEMBER 21, 2023

Join the First Discussion after the 25 August Effective Date Trudy Patterson Thu, 09/21/2023 - 08:38 iSpeak Blog iSpeak Annex 1 in Force! Moreover, Gilabert's insights into balancing cost and quality standards will be invaluable to industry professionals striving for excellence. Annex 1 in Force! The 2023 ISPE Pharma 4.0™

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Documentation FDA 98

ISPE

NOVEMBER 2, 2022

2022 ISPE Annual Meeting: Transform, Collaborate, & Innovate for the Path Forward. iSpeak Blog. 2022 ISPE Annual Meeting: Transform, Collaborate, & Innovate for the Path Forward. The industry is in the process of a transformation that was sped up by the pandemic, which enhanced innovation and collaboration.

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ISPE

DECEMBER 7, 2022

iSpeak Blog. The hour-long virtual event welcomed speakers Teresa Minero, Founder & CEO of LifeBee, and Dr. Frank Thielmann, Head of Lean in Global Operational Excellence at Takeda – each of whom brought their expertise and passion for a more sustainable pharmaceutical industry to the conversation. Trudy Patterson. 7 December 2022.

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ISPE

SEPTEMBER 8, 2023

The Drug Shortages Prevention Model describes three foundational areas for accountability: quality and manufacturing maturity, regulatory, and technology and innovation. The ISPE Drug Shortages Team developed the model as a follow-up to the ISPE Drug Shortages Prevention Plan that was released in 2014.

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Documentation 91

ISPE

JANUARY 31, 2023

The Culture Club: Upskilling - A Skill of Survival – Part 3 of 4 Trudy Patterson Tue, 01/31/2023 - 15:24 iSpeak Blog iSpeak The Culture Club: Upskilling - A Skill of Survival – Part 3 of 4 Michelle Vuolo Levi Schenk Andre L. Walker, CPIP Brandi M. As Linder/Undheim stated in Augmented Lean1, “.

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Roots Analysis

SEPTEMBER 1, 2023

In this blog post, I’ll explore how pharma / biotech companies can leverage the blue ocean and red ocean strategy to make waves in the market. In the fiercely competitive landscape of the pharma and biotech industries, standing out from the crowd is crucial for success.

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Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

MARCH 21, 2023

™ DACH Emerging Leader Hackathon Trudy Patterson Tue, 03/21/2023 - 15:57 iSpeak Blog iSpeak 2022 ISPE Pharma 4.0™ The biopharmaceutical company's facilities provided a live experience in the on-site labs where participants could work on innovative solutions for specific industry problems. 2022 ISPE Pharma 4.0™

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DiversifyRx

NOVEMBER 23, 2022

In this blog, our good friend Kris Rhea from Biolyte will help us dive into ACOs and their impact on the independent pharmacy owner. Since these services are critical for the survival of the ACO, it presents an excellent opportunity for pharmacies to provide these services. About Kris. What is an ACO? Now, that’s not sustainable.

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Health and Personal Care Stores Independent Pharmacies Patient Care Immunization 98

ISPE

MAY 22, 2023

A preview was given of the new ISPE Drug Shortages Prevention Model in which drug shortage prevention focus areas such as quality and manufacturing, regulatory and technology, and innovation align with ISPE’s Communities of Practice and other resources.

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Communication FDA 98

Omnicell

JANUARY 10, 2023

Always pushing the envelope on innovation, Sentara RMH Medical Center is an example of a hospital that never stops striving to adapt and adopt to achieve operational excellence with modern medication management solutions. Inevitably a medication management error will happen. Sentara is not one of those hospitals.

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Hospitals Omnicell Inventory Control Packaging 52

ISPE

MARCH 3, 2023

Trudy Patterson Fri, 03/03/2023 - 13:15 iSpeak Blog iSpeak ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track! Computer System Validation should not be a hindrance to innovation. ISPE Europe Annual Conference, 8th to 10th May 2023 - What You Need to Know about the GAMP® Track!

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Documentation FDA 98

ISPE

JULY 21, 2023

ICH Q9 (R1): The Next Frontier Trudy Patterson Fri, 07/21/2023 - 11:53 iSpeak Blog iSpeak ICH Q9 (R1): The Next Frontier Christopher John Potter, PhD 21 July 2023 A one-day seminar titled ICH Q9(R1): The Next Frontier was hosted by the Pharmaceutical Regulatory Science Team (PRST) at the Technological University Dublin (TU Dublin) on 1 June 2023.

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Documentation 98

Roots Analysis

NOVEMBER 3, 2023

NAMPT inhibitors are a class of drugs that target the enzyme nicotinamide phosphoribosyltransferase (NAMPT). This enzyme plays a crucial role in the production of nicotinamide adenine dinucleotide (NAD + ), a molecule that is essential for cellular metabolism. Several trials focused on evaluation of such drugs were discontinued in the past.

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FDA 40

ISPE

JUNE 27, 2023

Korakianiti started by referring to the EMA Quality Innovation Group (QIG), which contains EMA assessors and some academics. This is a good starting point for sponsors to have discussions regarding regulatory approaches and questions as well as an opportunity to teach regulators about the proposed new, innovative technology.

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Communication FDA Vaccines 52

Roots Analysis

JUNE 30, 2023

Upon realizing the potential of digital biomanufacturing over traditional processes, players are actively undertaking initiatives to adopt advanced platforms to drive operational excellence, visibility, control and synchronization in bioprocessing. Industry 4.0: technologies.

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Roots Analysis

JANUARY 2, 2024

By analyzing feedback from competing apps, developers can identify areas for improvement and innovation. Patient engagement refers to a strategic collaboration between patients and their treatment providers to offer all the relevant resources to patients in order to enable them to make appropriate decisions for their health.

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Health and Personal Care Stores Medical Records Prescription Management Communication 40

ISPE

SEPTEMBER 28, 2022

iSpeak Blog. In addition to the keynote presentations from industry and regulatory leaders from organization such as Takeda, Pfizer, or FDA, we take a deep dive into the five content areas: Digital Transformation, Manufacturing Trends, Regulatory and Quality, Supply Chain Optimization, and Therapy Innovations. Tue, 09/27/2022 - 13:39.

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PQA

MARCH 1, 2023

Jazz Pharmaceuticals use deep knowledge of and commitment to these fields to innovate and identify new solutions where none previously existed. New organizations regularly join PQA throughout the year. Below is more information on each of our new members and a link to their website. News & World Report.

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Board Vitals - Pharmacist

JANUARY 18, 2023

Many of these technology-based innovation are part of national drive to modernize medical education via the AMA’s Accelerating Change in Medical Education Initiative. Or imagine if our apps gave expert or Olympic-athlete feedback and coaching—all while we’re actually jogging in our local park? these are not futuristic or “what-if” scenarios.

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Medical Schools Patient Care HIPAA Communication 52

ISPE

JUNE 14, 2023

It has become apparent that complementary approaches are necessary to address supply and demand driven shortages, including the need to innovatively transition from lagging indicators such as Quality Defect reports, inspection data, and application data to leading approaches driven by QMM ratings and appropriate Quality Metrics (QM).

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The FDA Law Blog

DECEMBER 6, 2023

filed comments on behalf of the Coalition to Preserve LDT Access and Innovation in response to FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices. Javitt — On Monday, Hyman, Phelps & McNamara, P.C. Weighing in at nearly 60 pages, the comments detail extensive flaws in the proposed regulation.

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FDA 59

ISPE

NOVEMBER 23, 2022

iSpeak Blog. Discussions on Addressing Divergent Global QOS Requirements were a highlight of the session Regulatory Considerations to Boost Innovation and Supply Chain Resilience which was led by track leads Ciby Abraham and Connie Langer. Regulatory Insights from 2022 ISPE Annual Meeting. Trudy Patterson. Wed, 11/23/2022 - 12:32.

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FDA Documentation 52

Viseven

NOVEMBER 9, 2022

Many healthcare professionals opt to become KOLs because it allows them to share and increase their knowledge about the latest innovations, better treat their patients, widen their professional circle, and receive handsome compensation. These professionals are known as the KOL (key opinion leader) in pharma industry.

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Pharma Marketing Network

MAY 13, 2022

The award honors their commitment to excellence and the valuable contributions to their company’s success. Beth has continuously leveraged her medical expertise and business acumen to further to innovation of medicine and improve patient outcomes. This was my first WOTY and my first in person event in 2 years! What Is WOTY All About?

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Roots Analysis

SEPTEMBER 5, 2023

The early stages of research related to drug discovery, including the identification of a relevant biological target and a viable lead compound, play a crucial role in the overall success of a drug candidate in preclinical and clinical studies. In recent years, quantum computing technology potential has evolved to revolutionize various industries.

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PQA

AUGUST 21, 2023

Learn more about them in this Q&A blog. Leonard brings her passion and unique perspective to the innovative PQA team and aims to further advance the healthcare quality landscape. PQA and its Executive Fellowship program have been a beacon of excellence and innovation in healthcare quality.

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Patient Care FDA 40

ISPE

OCTOBER 10, 2022

iSpeak Blog. Meet the 2022 FOYA Honorable Mention Winner: lovance. Trudy Patterson. Mon, 10/10/2022 - 10:16. Meet the 2022 FOYA Honorable Mention Winner: lovance. Marcy Sanford. 10 October 2022. Until now this treatment has proven to be a challenge to deliver to patients in a scalable, timely commercial manner.

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Hospitals Immunization 98

ISPE

OCTOBER 31, 2022

iSpeak Blog. FOYA is about innovation, creativity, and facility design.” We receive a lot of excellent submissions this year and it was incredibly difficult to narrow down to these select winners. CRISPR won the award for creating a flexible, digitally-enabled facility that brings the promise of innovation to life.

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ISPE

OCTOBER 31, 2022

iSpeak Blog. FOYA is about innovation, creativity, and facility design.” We receive a lot of excellent submissions this year and it was incredibly difficult to narrow down to these select winners. CRISPR won the award for creating a flexible, digitally-enabled facility that brings the promise of innovation to life.

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Vaccines Packaging 52

ISPE

OCTOBER 31, 2022

iSpeak Blog. FOYA is about innovation, creativity, and facility design.” We receive a lot of excellent submissions this year and it was incredibly difficult to narrow down to these select winners. CRISPR won the award for creating a flexible, digitally-enabled facility that brings the promise of innovation to life.

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Vaccines Packaging 52

ISPE

OCTOBER 27, 2022

iSpeak Blog. We are The Culture Club, a self-formed cross-CoP group of individuals who came together to discuss the quality/validation challenges encountered as we transition into the digital world and identify ways to influence cultural changes needed within our industry to better enable innovation. Trudy Patterson. Michelle Vuolo.

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Documentation 52

Colors Make me Happy

APRIL 3, 2021

The term “co-dependency” was initially coined by Alcoholics Anonymous in 1950 to describe those individuals whose unhealthy choices enable and encourage their partner with addiction. While this is still true, co-dependency more recently has a much broader definition. Enmeshment simply means growing up in a family system that lacks boundaries (e.g.,

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Packaging 52

ISPE

MAY 25, 2023

Moving from a compliance mindset to a quality mindset includes shifting away from precisely matching the phraseology of the regulations to focusing on meeting the intent of the regulations through critical thinking and pragmatic approaches leveraging the innovative technologies available to us now that were so lacking in 1997.

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FDA 96