INDIVIRTUS Solutions (P) LTD https://validator.w3.org/feed/docs/rss2.html Management Team Home Our Specializations slider testing Insurance Services Home Data Management Services Accounting Services About Us What is a Development Safety Update report (DSUR)? Could Occupational Exposure Limits (OELs) or Occupational Exposure Bands (OEBs) be used to support assessment of products to determine whether they may be highly hazardous? What is a Risk Management Plan? Is the application of the Threshold of Toxicological Concern (TTC) as applied in the guideline of mutagenic products of 1.5 µg/person/day concept an acceptable default approach to establish an HBEL? What is a Signal? What is a Periodic Benefit-Risk Evaluation Report (PBRER)? What is a Periodic Safety Update Report (PSUR)? What is REMS? What is an ICSR? What is a Suspected Unexpected Serious Adverse Reaction (SUSAR) Where products for paediatric populations are manufactured in shared facilities with products intended for administration to adults or to animals, do the HBELs need adjustment? What are Good Pharmacovigilance Practices (GVP) and GVP modules? What is Adverse Drug Reaction (ADR)? How can inspectors determine the competency of the Toxicology expert developing the health-based exposure limit? What is an Adverse Event? What is Pharmacovigilance (PV) or Drug Safety? What role do HBELs play in meeting the requirements of GMP Chapter 5 section 20? How can limits for cleaning purposes be established? Is it acceptable to simply segregate products of a common therapeutic classification in a dedicated area as a means of controlling risk of cross contamination? Should the HBEL be re-assessed throughout the phases of development of Investigational Medicinal Products (IMPs)? Medical Dictionary for Regulatory Activities (MedDRA) How can the HBEL model be applied to early phase Investigational Medicinal Products (IMPs) where limited data is available? Can calculation of HBELs be based on clinical data only? What are the regulatory expectations with respect qualification and experience of a toxicologist? What competencies are required for the person developing the Health-Based Exposure Limits (HBEL)? Is the use of LD50 to determine health based limits acceptable? What is a product quality complaint? Do companies have to establish Health Based Exposure Limits (HBELs) for all products? What purpose PDE is used in the context of cleaning validation? What are the six seriousness criteria for a Serious Adverse Reaction? What is PDE and why it is needed in the context of cleaning validation? What is cleaning validation? What is an Unexpected Adverse Drug Reaction?