pharmaphorum

MAY 27, 2022

Once stakeholders are confident that technologies are adequately validated, selection based on scientific and ethical considerations can be presented to regulators in accordance with applicable legal and regulatory frameworks. There is a huge opportunity for pharma companies to capitalise on by focusing on increased DEI in clinical trials.

Clinical Trials 80

Clinical Trials Clinical Trials Trials Packaging 80

Advarra

JULY 19, 2022

The standard for the audit used depends on the type of vendor and would include the applicable regulations and ICH guidelines. Q: What is the typical time period between the submission of the briefing package and the pre-IND meeting? The sponsor-initiated IND is conducted by a pharma company seeking commercial approval.

Packaging 52

Packaging Packaging Drugs Containment 52

Drug Discovery World

MARCH 29, 2023

The commission is looking to put more pressure on pharma companies to report such shortages, and to offer a drug’s marketing authorisation to another company before withdrawing it from the market. She also does not believe that the problems with Europe’s medicines can be solved with regulation.

Clinical Trials 52

Clinical Trials Clinical Trials Production Medicine 52

pharmaphorum

MAY 26, 2022

While many pharma companies are actively working on initiatives to improve diversity in clinical trials, we still have a long way to go. A risk-benefit approach underpins the decision-making process to evaluate human drugs, drug/device combinations and advanced therapy medicinal products for licensing of human medicines.

Clinical Trials 143

Clinical Trials Clinical Trials Trials Medicine 143