European Pharmaceutical Review

MARCH 5, 2024

The four analytica forums offer practical best-practice lectures, with the Occupational Safety and Security Forum highlighting dangers in daily laboratory work through impressive live demonstrations. Visitors can gain insights into compliance with industry-specific validation guidelines and requirements such as GMP , GLP, REACH and FDA.

Consulting 88

Consulting Pharmaceutical Transportation Safety 88

Pharmaceutical Technology

JULY 7, 2022

While just two gene therapy products have been approved by the FDA, a number of companies are nearing the market with therapies targeting rare diseases, including 14 candidates in Phase III plus three in the pre-registration phase, according to GlobalData.

Medicine 98

Medicine Transportation Manufacturing Biopharma 98

pharmaphorum

JULY 28, 2022

These supply chain issues raise significant risks for the industry due to shortcuts being taken that are not based on product safety and quality. That means maintaining regulatory readiness – because having cGMP compliance problems with the FDA can significantly exacerbate the problem. Tackling shortages. About the Author.

Pharma 104

Pharma FDA Consulting Manufacturing 104

Pharmaceutical Technology

AUGUST 24, 2022

To ensure samples arrive at the lab intact, robust sample transportation and global logistics are critical. A central lab with a global footprint provides both the efficient transportation arrangement and scientific rigor required to unlock the valuable information contained within patients’ biological samples.

Transportation 52

Transportation Patients Safety Marketing 52

Pharma Marketing Network

MARCH 25, 2022

80% provide transportation 1. The FDA has studied the importance of caregivers to drug development and regulatory decision-making. Caregiver observations of the patient experience over the progression of the disease may inform the safety and efficacy of a particular therapeutic. 98% provide emotional support 1.

Pharma 98

Pharma Education Transportation Training 98

Pharmaceutical Technology

OCTOBER 28, 2022

They inform industrial scientists what is necessary to ensure that their product meets the safety and efficacy requirements to get a product approved in humans. For companies in the US, if the results show bioequivalence, an abbreviated new drug application (ANDA) containing the results is sent to the FDA to review and potentially approve.

Manufacturing 52

Manufacturing Safety Medicine Pharmaceutical products 52

PM360

AUGUST 9, 2022

The industry has been limited in its ability to implement creative solutions to engage and motivate patients because the FDA has strict guidelines for what pharma companies can communicate with patients. Measuring and monitoring adherence in clinical trials would add valuable information about the effectiveness and safety of drugs.

Medical 105

Medical Electronics Patients Healthcare 105

Pharmaceutical Technology

JANUARY 10, 2023

The erosion of Januvia is due to patent expiry in that had been expected in 2022 and physicians’ preference for sodium-glucose linked transporter-2 inhibitor (SGLT-2I) therapies such as Farxiga (dapagliflozin) and Jardiance (empagliflozin) due to their ability to improve glycemic control and address cardiorenal comorbidities.

Marketing 52

Marketing Physicians Leads Sales 52

Clarify Health

DECEMBER 13, 2022

Prior to him walking in, the sponsor and pharmacy already have a holistic view of his patient journey and understand factors affecting his lifestyle, such as whether he buys cigarettes or lacks transportation. Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence?

Recruitment 52

Recruitment Retail Patients Education 52

Clarify Health

DECEMBER 13, 2022

Prior to him walking in, the sponsor and pharmacy already have a holistic view of his patient journey and understand factors affecting his lifestyle, such as whether he buys cigarettes or lacks transportation. Question: What’s the FDA’s approach to unlocking the full promise of real-world evidence?

Recruitment 52

Recruitment Retail Patients Education 52

pharmaphorum

OCTOBER 26, 2022

There are many challenges in the development of therapies for rare diseases due to several unique factors, including small target patient populations, lack of long-term safety and efficacy data or natural history data, and often complex administration, dosing, and patient monitoring requirements,” Chiesi says.

Patients 88

Patients Pharma Consulting Transportation 88

PM360

SEPTEMBER 15, 2022

With a more patient-inclusive approach focused on DEI, clinical research can promote health equity and the safety and effectiveness of new treatments for all patients. In April, the FDA released an updated draft guidance identifying steps to improve diversity in clinical trials. Michael Zilligen.

Patients 98

Patients Healthcare Healthcare Marketing 98

Pharmaceutical Technology

MAY 11, 2008

RFID has other advantages in that it can be used to monitor conditions such as temperature during transport of the drugs. The pilot scheme for this has been observed by the FDA and EU Commission. The trial was promoted by Dr Barry White, director of the NCHCD, after he became concerned about the safety of medication for haemophiliacs.

Electronics 52

Electronics Transportation Pharmaceutical manufacturing Pharmaceutical 52