RSS Feed
Search Ask-Cato.com
Tags
adverse events biologics biosimilar biotech cancer Cato BioVentures Cato Research CDER clinical investigator clinical research clinical trials CMC conference CROs DIA drug development eCTD efficacy FDA funding GlobalSubmit guidance Health Canada IND in vitro diagnostics labeling manufacturing marketing application medical devices NDA NIH nonclinical research oncology Phase 1 Phase 2 postmarketing protocol regulatory affairs safety statistical analysis toxicology transparency venture capital warning letters webinarCategories
- Clinical Trials (52)
- Conferences and Meetings (34)
- eCTD (26)
- FDA (71)
- Guest Posts (5)
- Health Canada (6)
- Industry News (56)
- Project Management (1)
- Publications (7)
- Regulatory Strategy (36)
- Social Media (6)
- Statistics (9)
- Uncategorized (1)
- Venture Capital (10)
- Webinars (24)
Tag Archives: regulatory affairs
New Informed Consent Requirements Improve Transparency in Clinical Trials
Trust, honesty, humility, transparency and accountability are the building blocks of a positive reputation. Trust is the foundation of any relationship. – Mike Paul Transparency of clinical research to participants and patients is what the FDA is going for with … Continue reading
Posted in Clinical Trials, FDA, Industry News, Regulatory Strategy
Tagged biologics, clinical trials, drug product, FDA, FDAAA 2007, IND, regulations, regulatory affairs, safety, transparency
1 Comment
Download the Slides from the Data Quality and Integrity Webinar
Yesterday’s free webinar, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval,” was a great success! For those who would like them, the slides from the presentation are now available for download here (PDF file). Stayed tuned Ask-Cato.com for … Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged Cato Research, clinical study report, clinical trials, data standards, drug development, marketing application, regulatory affairs, webinar
Comments Off
Data Quality and Integrity: From Clinical Monitoring to Marketing Approval
At 2:00 PM ET on Thursday 18 November 2010, Cato Research will host a webinar titled, “Data Quality and Integrity: From Clinical Monitoring to Marketing Approval.” The webinar will be presented by Nancy Detich, Ph.D., a Senior Clinical Strategy Scientist … Continue reading
Posted in Clinical Trials, Regulatory Strategy, Webinars
Tagged Cato Research, clinical study report, clinical trials, data standards, drug development, marketing application, regulatory affairs, webinar
Comments Off
Vendor Selection – All that Glitters is Not Gold
One of the most important, and difficult, decisions a company has to make is selecting the right contract research organization (CRO) for outsourcing its nonclinical, manufacturing, clinical and regulatory activities. Several variables determine what makes a good outsourcing partner – … Continue reading
Posted in Clinical Trials, Regulatory Strategy
Tagged biotech, clinical trials, CMC, CROs, drug development, funding, IND, manufacturing, nonclinical research, outsourcing, pre-IND, regulatory affairs
Comments Off
RAPS Preconference Workshop – EU Regulatory Affairs Essentials
Image via Wikipedia The 2010 RAPS Annual Conference and Exhibition will be from Sunday, 24 October to Wednesday, 27 October at the McEnery Convention Center in San Jose, CA. While the “main event” kicks off on Monday, 25 October at … Continue reading
Posted in Conferences and Meetings, Regulatory Strategy
Tagged Cato Research, conference, EU, marketing application, pharmacovigilance, RAPS, regulatory affairs
Comments Off
