DSCSA Requirements and Responsibilities for Drug Manufacturers (Sponsor vs CMO)
With the final deadline for complete compliance with the FDA's Drug Supply Chain Security Act (DSCSA) looming on the horizon, where do you find your organization? Although the FDA has now issued two...
Meet the Expert: Kamila Rocha
Our "Meet the Expert" series introduces you to our team of experts around the world. This "behind the curtain" view will help you get to know who we are on a professional and personal level, and...
What is the Drug Supply Chain Security Act (DSCSA)?
Update: The FDA has recently granted a one-year extension until November 27, 2024, for the enforcement of system-wide electronic interoperable systems that track products throughout the supply chain....
Artificial Intelligence in the Medical Information Industry: Transforming Healthcare with AI and Automation
The rapid advancement of artificial intelligence (AI) technology has revolutionized various industries, including the medical information sector. One notable AI-driven tool is ChatGPT, developed by...
Patient and Healthcare Provider Satisfaction Surveys: Maximizing Response Rates
Customer perception and satisfaction play a pivotal role in shaping the success and reputation of pharma companies. Given the significance of these factors, it's understandable that many pharma...
The Quality of Your Medical Writing Matters (And Here’s Why)
Medical writers need to meet a few critical criteria before they publish their work. First and foremost, people want to see accuracy and explicit knowledge of the field when they’re seeking out...
Rapid and Responsive Implementation the Right Way
During the COVID-19 global pandemic, Medical Information (MI) and Pharmacovigilance (PV) teams are providing an extremely valuable service to deliver current and accurate product information to...
4 Key Parts to a Complete Product Complaint Handling Program
4 Key Parts to a Complete Product Complaint Handling ProgramAccording to 2012 FDA statistics, drug company’s Product Complaint handling systems (21 CFR 211.198) were cited in 142 Turbo EIR...