ISPE

NOVEMBER 23, 2022

The PIC/S Deputy Chairperson, Susan Laska, US FDA, outlined the evolution of pharma industry and PIC/S, including background information on the operations of PIC/S. The initial phases of the initiative would involve concurrent pilot projects of collaborative hybrid inspections and collaborative assessments of CMC.

Documentation 98

Documentation FDA Communication 98

ISPE

DECEMBER 1, 2022

The “Graziella Molinari Women in Pharma Award” Announced for 2022 Edition at the ISPE Italy Affiliate. The “Graziella Molinari Women in Pharma Award” Announced for 2022 Edition at the ISPE Italy Affiliate. The Graziella Molinari Award fits into the context of the activities of the Italian branch of Women in Pharma. iSpeak Blog.

98

98

ISPE

JULY 20, 2023

The 36 participants were then split into six teams and the problem statement was revealed to them along with a short crash course into ATMPs and Pharma 4.0™ Throughout the 24-hour period, the hackers had the luxury of calling upon esteemed coaches in the field of ATMPs and Pharma 4.0 ™ to level the playing field.

52

52

ISPE

FEBRUARY 15, 2023

To reinforce globally harmonized implementation of ICH guidelines that are functionally necessary to advance innovative technology and approaches such as Pharma 4.0, for example a globally agreed control strategy.

Dosage 95

Dosage FDA 95

Pharmaceutical Technology

NOVEMBER 9, 2022

The legacy of this disruption has been a rethink in the way pharma companies do business. The pharma supply chain is emerging strongest and most sustainable where there is a high level of automation and digitalization. Pharmaceutical commentators are heralding the advent of “Pharma 4.0.” what it means for you.

Vaccines 52

Vaccines Packaging Communication 52

ISPE

NOVEMBER 30, 2022

Making Maintenance a True Asset in Pharma Manufacturing Through Digitalization. Making Maintenance a True Asset in Pharma Manufacturing Through Digitalization. In a recent report by AspenTech, in collaboration with FT Longitude, PPM was cited among the top four digital initiatives to improve operational agility and efficiency.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

pharmaphorum

JANUARY 8, 2021

The use of real-world evidence (RWE) has grown rapidly in pharma over the last few years, as healthcare payers and regulatory agencies have tried to get a deeper understanding of the impact medicinal products have in actual practice, rather than just within clinical trial settings.

105

105

ISPE

MARCH 30, 2023

Greenfield facilities that have been the first to embrace the tools of Pharma 4.0 Industry 4.0, The digital thread view will provide attendees with a roadmap template they could use to initiate their digital transformation assessment.

Documentation 98

Documentation 98

pharmaphorum

JULY 22, 2022

Advances in Pharma 4.0 Stringent regulatory standards for product approvals, technological advancements in cleanrooms, initiatives taken by private organisations to create awareness regarding cleanroom and growth of the healthcare sector globally are among the few factors expected to drive the market.

Compounding Pharmacies 52

Compounding Pharmacies Compounding 52

ISPE

FEBRUARY 16, 2023

Regulators discussed those changes and how they impact manufacturing practices during panel discussions held 7 - 8 December 2022 at the ISPE Pharma 4.0™ Do regulators see benefits that Pharma 4.0 Pharma 4.0 In Europe, there is Quality Innovation Group (QIG) which could support such initiatives.

Documentation 52

Documentation FDA 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.

52

52

ISPE

SEPTEMBER 8, 2023

The Initiative This initiative is consistent with ISPE’s mission and vision and is aligned with the advancement of the Pharma 4.0™ Diverse regulatory expectations create additional burdens and challenges in carrying out continual improvement initiatives.

FDA 52

FDA Dosage Documentation Communication 52

ISPE

NOVEMBER 2, 2022

2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives. 2022 ISPE Annual Meeting: New Chair, New Year of ISPE Initiatives. Vetter Pharma-Fertigung GmbH & Co. Jörg Zimmermann, International Board Chair for 2021–2022 and Vice President, Vetter Development Service, External Affairs, Vetter Pharma-Fertigung GmbH & Co.,

Documentation 52

Documentation Compounding Communication FDA 52

ISPE

MAY 2, 2023

First, this conference has been developed by the best possible program committee: the committee members have deep knowledge of the content areas, are attuned with the latest industry trends, and come from all aspects of the broad pharma and life sciences community. Resources, Organization, Culture, and Information Systems. To make it real.

98

98

ISPE

FEBRUARY 17, 2023

FDA has two programs that are helping to support early-stage development, working toward accelerated approval and areas such as advanced manufacturing: INitial Targeted Engagement for Regulatory Advice on CBER ProducTs (INTERACT) and CBER Advanced Technologies Team (CATT). They followed many concepts from Pharma 4.0™.

FDA 98

FDA Vaccines 98

ISPE

JULY 26, 2023

In parallel with these efforts, the ISPE Drug Shortages Initiative team has developed expanded guidance on drug shortage prevention, addressing the quality, technical, and regulatory aspects. By coming together at the 2023 ISPE Annual Meeting & Expo, pharmaceutical professionals can collaboratively Shape the Future of Pharma™.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

OCTOBER 31, 2022

The fast-track project included designing and building a new facility in 9 months and securing regulatory approval for the initial commercial batches in 12 months. Project Execution - Janssen Biologics, BV for their Vaccine Launch Facility Expansion in Leiden, the Netherlands. Previous Slide ?? Next Slide ??.

Vaccines 52

Vaccines Packaging 52

ISPE

SEPTEMBER 11, 2023

These new operating models can help enable and accelerate the efforts of Pharma 4.0™ These new operating models can help enable and accelerate the efforts of Pharma 4.0™ Industry 4.0 Technologies Description Industry 4.0 ™ toward the implementation of smart manufacturing, digitization, and automation.

Health and Personal Care Stores 52

Health and Personal Care Stores Vaccines Packaging Documentation 52

ISPE

NOVEMBER 1, 2022

Vetter Pharma-Fertigung GmbH & Co. All of this energy has been channeled by the International Board into a rewriting of the ISPE Strategic Plan for 2023–25 with a “more confident position: Shaping the Future of Pharma.”. Industry 4.0 Jörg Zimmermann. Vice President, Vetter Development Service, External Affairs. President & CEO.

FDA 98

FDA Insurance Chemotherapy Documentation 98

European Pharmaceutical Review

OCTOBER 2, 2023

CPHI Barcelona, the renowned global pharma event, is set to take centre stage from 24 to 26 October 2023 at Fira Barcelona Gran Via, Spain. CPHI creates connections and inspires partnerships across the global pharma community. CPHI creates connections and inspires partnerships across the global pharma community.

Packaging 102

Packaging 102

ISPE

FEBRUARY 7, 2023

The two-day conference on 31 January–1 February featured a range of sessions on topics including biomanufacturing, cell and gene therapy, digital transformation and Pharma 4.0™, Initiatives in the pharmaceutical industry include the NIIMBL consortium. ™, emerging technologies, and facility design and construction.

Vaccines 88

Vaccines Dosage Hospitals 88

PharmaShots

JUNE 6, 2023

With the impelling Pharma 4.0, Diagnosis: A major spike is witnessed in partnership initiatives among tech companies and the pharmaceutical industry to provide early diagnosis of diseases. With this integration, companies can recalibrate their strategies and focus more on potential drugs with higher success ratios.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Mayo Clinic Data Entry 40

ISPE

OCTOBER 31, 2022

The fast-track project included designing and building a new facility in 9 months and securing regulatory approval for the initial commercial batches in 12 months. Takeda Pharma. Project Execution - Janssen Biologics, BV for their Vaccine Launch Facility Expansion in Leiden, the Netherlands. Previous Slide ?? Next Slide ??.

Vaccines 52

Vaccines Packaging 52

ISPE

OCTOBER 31, 2022

The fast-track project included designing and building a new facility in 9 months and securing regulatory approval for the initial commercial batches in 12 months. Takeda Pharma. Project Execution - Janssen Biologics, BV for their Vaccine Launch Facility Expansion in Leiden, the Netherlands. Previous Slide ?? Next Slide ??.

Vaccines 52

Vaccines Packaging 52

ISPE

JUNE 27, 2023

Question: How do individual agency regulatory initiatives and flexibilities align to ensure that MRA agreements are not undermined? Question: What levels of co-ordination are happening regarding different innovation initiatives? Question: At the 2022 ISPE’s Pharma 4.0 As Rosa commented “be prepared to teach us”.

Communication 52

Communication FDA Vaccines 52

European Pharmaceutical Review

JULY 5, 2022

Oncoral (Ascelia Pharma) is a novel patented tablet formulation of irinotecan, currently in Phase II clinical development, for daily dosing at home. The initial indication for Oncoral is stomach cancer, but it could offer the potential of improving treatment for other types of cancer in the future. International License ( [link] ).

Chemotherapy 90

Chemotherapy Dosage Labelling Compounding 90

ISPE

NOVEMBER 23, 2022

A presentation on ISPE’s Pharma 4.0® ® program was delivered by the chair of that program, Christian Wölbeling, Executive Industry Advisor, Körber. Djamila Harouaka, an advisor in the Office of Pharmaceutical Quality, USFDA/CDER, presented FDA’s Quality Management Maturity Program.

FDA 52

FDA Documentation 52

ISPE

NOVEMBER 10, 2022

Later in my career, I started to realize and apply myself to the many gaps that exist between the initial R&D of treatments and how to scale them in manufacturing to bring these products to patients. There are examples and inspiration generally in the pharma industry for point use cases such as in biofermentation and continuous manufacturing.

Documentation 98

Documentation Compounding Hospitals Immunization 98

ISPE

JULY 6, 2023

Several of these drugs, such as Pfizer’s oncology drug Daurismo (glasdegib), were initially approved with a batch production process and then transitioned to CM afterward. Pharma Investment Trend Report: What We’re Watching in 2023.” End-to-End: Can Pharma Finally Make the Dream of Continuous Manufacturing a Reality?”

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

OCTOBER 27, 2022

Just as with language, translating our habits and expert knowledge requires initiative, practice, and immersion for full learning. So let’s dive into some real questions and start working out those creative muscles here and now… (answers may vary depending on where in the industry you work: CRO, biotech, big Pharma, medical devices, etc.).

Documentation 52

Documentation 52

ISPE

MAY 9, 2023

There are so many other biotech and pharma companies in this region that all the necessary departmental needs are here, including manufacturing technicians, facility mechanics, process and automation engineers, supply chain, validation specialists, and those experts in QA and QC.” As automation and Pharma 4.0

Vaccines 94

Vaccines Pharmaceutical Companies Pharmaceutical Companies Medical Schools 94

ISPE

JULY 5, 2023

To address the regulatory framework for these additional technologies, CDER began an initiative called the Framework for Regulatory Advanced Manufacturing Evaluation (FRAME) to prepare a regulatory framework to support the adoption of prioritized advanced manufacturing technologies that could bring benefits to patients. Outsourced Pharma.

FDA 52

FDA Dosage Documentation Pharmaceutical Companies 52

ISPE

JULY 6, 2023

At the business unit level, the risk appetite approach could be leveraged in product development and new initiatives such as manufacturing technology investments. It starts with identifying all the risks associated with a CM initiative. Engineering cost uncertainty presents another source of financial risk to pharma manufacturers.

Insurance 52

Insurance Documentation Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

OCTOBER 27, 2022

These equipment design elements also allow a system to operate in a different geographic setting or service conditions than its initial establishment and validation. Finally, such comprehensive digital initiatives as Industry 4.0 Pharma Manufacturing website. Utility Panel Design and Optimization. 7 Langhauser, K.

Packaging 52

Packaging Communication Immunization Vaccines 52

PharmaShots

FEBRUARY 27, 2023

Through Global PHT Summit, it was for the first time that the pharma, healthcare, and technology veterans, pioneers, and professionals converged on the same platform to impart their knowledge on the best & futuristic PHT practices. Mr. Sethu then took over, describing the benefits of Pharma 4.0—a

Packaging 40

Packaging Hospitals FDA Pharmaceutical Companies 40

PharmaShots

MAY 1, 2023

Moreover, pharmaceutical companies constantly evolve with ongoing innovations, such as the integration of Pharma 4.0, In 2020, AstraZeneca reduced its workforce by 700 in the US and UK as part of a cost-saving initiative.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Vaccines 40

PharmaShots

MAY 1, 2023

Moreover, pharmaceutical companies constantly evolve with ongoing innovations, such as the integration of Pharma 4.0, In 2020, AstraZeneca reduced its workforce by 700 in the US and UK as part of a cost-saving initiative.

Pharmaceutical Companies 40

Pharmaceutical Companies Pharmaceutical Companies Vaccines 40