Electronic Product Information (ePI) refers to the electronic version of the Patient Information Leaflet (PIL) that is provided with medicines. The ePI contains important information about the medicine, such as its active ingredients, indications, contraindications, dosing instructions, side effects, precautions, and storage conditions.
- March 16, 2023 Pharmaceuticals, Regulatory Labeling
- March 16, 2023 Publishing & Submissions, Regulatory Software & Services
Electronic submissions have taken the life science industry's Regulatory space by storm. Majority of the Regulatory submissions are now made using the eCTD format globally. The benefits of eCTD are undeniable - faster, more efficient, and standardized. But transitioning from non-eCTD electronic Submission (NeeS) to eCTD isn't always a cakewalk.
- March 15, 2023 Pharmaceuticals, Compliance, Audit and Validation, Regulatory Affairs
Audits and adherence to dynamic regulations have posed serious challenges for various pharmaceutical organizations. To list down the forthcomings of pharma audits, FDA warning letters and compliance adherence letters are endpoints, thereafter the compliance bridging is in the hands of pharmaceutical companies.
- March 10, 2023 Medical Devices, Regulatory Affairs
Post-approval change management is the process of monitoring and maintaining the safety, effectiveness, and performance of a medical device after it has received Regulatory approval and has been placed on the market. This process involves continuous evaluation and management of changes to the device, including changes to its design, labeling, manufacturing, and usage.
- March 10, 2023 Medical Devices
ANVISA comes up with a new resolution, RDC 751, effective from March 01, 2023. The Resolution defines the risk classification rules for medical devices, labeling requirements and Instructions For Use (IFU), and the procedures for notification, registration, amendment, revalidation, and cancellation of notification or registration of medical devices. It revokes RDC no. 185/2001, RDC no.15/2014, and RDC no. 40/2015.
Meta-analysis is a subset of systematic reviews that combines pertinent qualitative and quantitative study data from several selected studies to develop a single conclusion with greater statistical power. This conclusion is statistically more significant than the analysis of any single research due to the increased numbers of subjects, greater diversity among subjects, or accumulated effects and results.
- March 9, 2023 Regulatory Contract Staffing, Regulatory Affairs, Regulatory Consulting
Are high-interest rates, rising inflation, and unpredictable economic climate influencing your organization’s downturn? According to one of the reports, the medical science industry will necessitate seventy thousand (70,000) Regulatory roles over the next decade. Filling these positions has been and will continue to be a challenge for the industry.
- March 9, 2023 Regulatory Affairs, Publishing & Submissions
The electronic Common Technical Document (eCTD) is an internationally recognized format for electronic submissions to Regulatory Agencies. The latest version of eCTD, eCTD 4.0, includes several new features and enhancements that can help streamline the Regulatory submission process. However, adopting eCTD 4.0 can be challenging for organizations that are used to older versions or paper-based submission systems.
- March 3, 2023 Pharmacovigilance
Pharmacovigilance (PV) involves activities for detecting, assessing, understanding, and preventing adverse drug effects/adverse events (AE) of drug products to ensure the safety of the patients.
- March 1, 2023 Food and Food Supplements, Regulatory Affairs
The Food Safety and Standards Authority of India (FSSAI) has released comprehensive Regulatory standards to identify basmati rice. This is the first time in the country that FSSAI has come up with a regulation that will establish ethical trading standards for basmati rice, which will also safeguard consumers' interests both domestically and internationally.