Planning, timing, and coordination. These three words may be the magic formula that Sponsors will have to adopt when the European Clinical Trials Regulation comes into force. Sponsors will have to prepare their timelines well to...
For many scientists and healthcare professionals involved in developing new medicines, patients, the people who represent the unmet need, are a primary motivating factor. To ensure that patients and physicians can make full use of a product’s potential, conveying...
[Fill out the form below to register] Abstract: When planning an Investigational New Drug (IND) or Clinical Trial Authorization (CTA) submission, navigating FDA, EMA, and other regulations can be challenging and creating scientifically-sound strategies are...
Regulatory document quality is of the utmost importance in the pharmaceutical, biotechnology, and medical device industries to ensure data accuracy and provide confidence in drawing reliable conclusions. A great quality control process ensures that the writing is...
The European Medicines Agency (EMA) recently announced the European Union (EU) Portal, a database for obtaining a clinical trial authorization, will be activated by the end of January 2022. The EU Portal will trigger the enforcement of the EU Clinical Trial...
The US Food and Drug Administration’s (FDA) Vaccines and Related Biological Products Advisory Committee (VRBPAC) met on Thursday, October 22, 2020, to discuss the development, authorization, and/or licensure of vaccines to prevent COVID-19. The committee heard from...
[Fill out the form below to register] Abstract: The Global Clinical Research Organization (CRO) market is expected to grow to $71.7 billion in 2024. Within that growth, Functional Service Provider (FSP) relationships are expected to grow at a CAGR of 5%-6%. Sponsor...
Remote audits are crucial for auditors and auditees in the pharmaceutical industry to help reduce health risks since the advent of the COVID-19 global pandemic. On-site inspections across pharma and other industries may not be possible due to multiple factors,...
[Fill out the form below to access the whitepaper] The Orphan Drug Act, established in 1983, provides incentives to sponsors for promoting the development of drugs for the prevention, diagnoses, and treatment of rare diseases or conditions that affect fewer than...