European Pharmaceutical Review

MAY 16, 2023

2 the global stem cell therapy market is estimated to reach $928.6 million by 2031″ Looking ahead to the next decade, the global stem cell therapy market is estimated to reach $928.6 This was compared to four percent of patients who took medication. million by 2031.

Hospitals 83

Hospitals 83

pharmaphorum

DECEMBER 2, 2022

Enrolling for clinical trials has become more challenging in recent years, with trial competition, increasingly complex protocols, and precision medicine targeting more niche patient populations. These potential study risks can lead to costly deviations and amendments, enrolment difficulties, and reduced patient compliance.

Compounding 98

Compounding 98

pharmaphorum

JULY 8, 2022

Preliminary research suggests that hybrid DCTs can reduce trial timing and resources , improve patient-centricity and patient engagement , and expand access and recruitment and increase diversity , mitigate bias, and reinforce inclusion in clinical trials. Regulatory support and clarity on DCTs guidance is essential.

FDA 83

FDA 83

ISPE

FEBRUARY 16, 2023

Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View Trudy Patterson Thu, 02/16/2023 - 09:23 iSpeak Blog iSpeak Regulatory Panel Discussions: Annex 1 Implementation from the Regulators’ Point of View Mark Birse Jean-Francois Duliere Alfred W. equipment is not available)? Pharma 4.0

Documentation 52

Documentation FDA 52

PharmaShots

MARCH 6, 2023

Shots: Iris shared the specifics of the launch of the UCB’s Innovators campaign. Iris Loew-Friedrich: Over the last decade, patients have been increasingly active and empowered when it comes to decisions concerning their health. As a result of this progression, our industry developed the notion of patient-centricity.

Immunization 40

Immunization Pharmaceutical Companies Pharmaceutical Companies Hospitals 40

pharmaphorum

MARCH 30, 2021

Chris Gray leads Innovation and Ventures for Adelphi’s Healthcare Communications agencies, whose long-running Renaissance series has been discussing the implications of ‘ transformational value ’. We are starting to see a more pragmatic approach to design of clinical trials, by for example looking at the whole patient journey.

Communication 62

Communication Labelling 62

ISPE

JULY 19, 2023

™ Is Gaining Momentum and Driving Innovation Trudy Patterson Wed, 07/19/2023 - 08:17 Online Exclusives July / August 2023 Pharma 4.0™ ™ Is Gaining Momentum and Driving Innovation Thomas ZIMMER, PhD 19 July 2023 The fifth Pharma 4.0™ has taken on significantly increasing momentum in the pharmaceutical industry. transformations.

Documentation 98

Documentation FDA Labelling Communication 98

ISPE

OCTOBER 31, 2022

FOYA is about innovation, creativity, and facility design.” ISPE President Tom Hartman added, “These are stories of people in the pharmaceutical industry as they endeavored to overcome seemingly impossible odds.”. CRISPR won the award for creating a flexible, digitally-enabled facility that brings the promise of innovation to life.

Vaccines 52

Vaccines Packaging 52

pharmaphorum

MARCH 31, 2021

Technology has enabled us to broaden the conversation and reach a far wider audience than previously possible,” commented panelist Charlotte Moseley, executive director of client engagement, McCann Health Medical Communications. The cancellation of live events in 2020 has demanded a different means of data communication.

Communication 98

Communication Pharmaceutical Companies Pharmaceutical Companies Vaccines 98

ISPE

OCTOBER 31, 2022

FOYA is about innovation, creativity, and facility design.” ISPE President Tom Hartman added, “These are stories of people in the pharmaceutical industry as they endeavored to overcome seemingly impossible odds.”. CRISPR won the award for creating a flexible, digitally-enabled facility that brings the promise of innovation to life.

Vaccines 52

Vaccines Packaging 52

ISPE

OCTOBER 31, 2022

FOYA is about innovation, creativity, and facility design.” ISPE President Tom Hartman added, “These are stories of people in the pharmaceutical industry as they endeavored to overcome seemingly impossible odds.”. CRISPR won the award for creating a flexible, digitally-enabled facility that brings the promise of innovation to life.

Vaccines 52

Vaccines Packaging 52

European Pharmaceutical Review

JUNE 16, 2023

With the adoption of digital technologies gaining traction in many industries, pharmaceutical companies must take advantage of digitalisation within its research and development (R&D) sector. Using digital means we can streamline communications, facilitate better patient engagement, and ultimately improve retention rates.

Communication 101

Communication Pharmaceutical Companies Pharmaceutical Companies Patient Care 101

ISPE

NOVEMBER 10, 2022

An interview with Shin Kawamata of Japan’s Foundation for Biomedical Research and Innovation (FBRI) highlights exciting work to move cell therapy toward reliable and scalable commercialization. Foundation for Biomedical Research and Innovation At Kobe. Pharmaceutical Engineering® recently spoke with Kawamata about his work.

Documentation 98

Documentation Compounding Hospitals Immunization 98

Pharma Marketing Network

APRIL 30, 2021

Clinical trials may be one of the very last bastions of a non-customer-focused approach within the pharmaceutical industry. Protocols, which have remained substantively unchanged for over 30 years, often impose an immense burden on patient participants, largely due to the frequency of site visits.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Documentation FDA 52

pharmaphorum

JULY 9, 2021

Digital technologies are proving their value by allowing for better care, improved adherence and a more connected ecosystem between doctors, patients and pharma. In an ideal world, we’d like every patient to have their own pain specialist, psychologist, dietitian, etc.,

Hospitals 69

Hospitals Communication Immunization Pharmaceutical Companies 69

pharmaphorum

JANUARY 12, 2021

2020 was a big year for market access initiatives in the UK, many of which are only just starting, and their impact will come through in 2021 and beyond. Whilst regulatory approval is only a starting step on market access, the UK has made steps to put the UK on the priority list for companies seeking marketing authorisation.

Documentation 68

Documentation 68

ISPE

SEPTEMBER 8, 2023

It is incumbent for industry to modernize manufacturing processes to improve efficiency and increase confidence in quality assurance for the benefit of patients while introducing novel technology and modalities as the science advances. Representatives from regulatory authorities are also encouraged to complete the survey.

FDA 52

FDA Dosage Documentation Communication 52

ISPE

FEBRUARY 15, 2023

It is incumbent for industry to modernize and innovate pharmaceutical manufacturing to improve efficiency and increase confidence in quality assurance for the benefit of patients. However, global implementation of new, innovative technology faces significant challenges that create barriers to implementation.

Dosage 95

Dosage FDA 95

ISPE

JULY 6, 2023

This article provides a review on the current state of CM implementation, offers insights into life cycle management and regulatory aspects, and explains how a data- and knowledge-centric approach to risk management can help CM achieve its full potential. This is demonstrated by the rise from $1.05 billion US in 2021 to $1.9

HIV Treatment and Prevention Agents 52

HIV Treatment and Prevention Agents Dosage Pharmaceutical Companies Pharmaceutical Companies 52

ISPE

MARCH 7, 2023

For decades, the pharmaceutical industry has worked to transform the lives of patients by researching, developing, and manufacturing medicines for a wide variety of common and rare diseases, something that will continue for many years to come. Global regulators are assessing drug products for quality, efficacy, and safety.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Hospitals 52

ISPE

MARCH 6, 2023

Challenges for Net Zero Carbon Pharmaceutical Manufacturing Trudy Patterson Mon, 03/06/2023 - 12:40 Features March / April 2023 Challenges for Net Zero Carbon Pharmaceutical Manufacturing Keith M. C global warming scenario by 2030, which is widely acknowledged to be necessary to avoid the worst impacts of climate change.

Packaging 52

Packaging Pharmaceutical Companies Pharmaceutical Companies Compounding 52

ISPE

AUGUST 29, 2022

Postapproval change management of pharmaceuticals is an essential part of life-cycle management but is associated with regulatory challenges. Regulatory submission and evaluation of chemistry, manufacturing, and controls (CMC) data may be required for changes that have a higher risk to impact product quality. Michael Abernathy.

Documentation 52

Documentation FDA Communication Packaging 52

ISPE

MARCH 29, 2023

to effectively convey the control strategy and clearly identify the established conditions (ECs) or regulatory binding elements that “are considered necessary to assure product quality and therefore would require a regulatory submission if changed post approval.” ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.”

Documentation 52

Documentation Dosage Packaging Communication 52

ISPE

MARCH 29, 2023

to effectively convey the control strategy and clearly identify the established conditions (ECs) or regulatory binding elements that “are considered necessary to assure product quality and therefore would require a regulatory submission if changed post approval.” ICH Harmonised Tripartite Guideline Q10: Pharmaceutical Quality System.”

Documentation 52

Documentation Dosage Packaging Communication 52

pharmaphorum

FEBRUARY 16, 2022

Patients were given access to Tagrisso before NICE finished their appraisal on a budget-neutral basis to the NHS. That gave patients the first access in Europe. More Project Orbis approvals may yet come in 2022, but industry should not expect that deals will always deliver faster access.

Pharmaceutical Companies 52

Pharmaceutical Companies Pharmaceutical Companies Vaccines 52