PHM321 (Industry) - Final Exam Questions with Correct Answers Already Passed

PHM321 (Industry) - Final Exam Questions with Correct Answers Already Passed List questions which regulatory affairs help pharmaceutical companies answer. - Answers - When can studies occur? - What trials are required to seek approval? - What claims can we make? - How fast can we get to market? - What do we need to do to stay compliant? List different types of regulations. - Answers - Laws/regulations (???) - Guidance documents - Policies - Position papers - Solicited advice List the original founding members of the ICH (International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use). - Answers USA, European Union, Japan. [Canada was added in 2016] LIST the different guidelines that are a part of the ICH guidelines. - Answers - Quality guidelines - Safety guidelines - Efficacy guidelines - Multidisciplinary guidelines [LIST] the 5 steps in the ICH procedure. - Answers 1. Consensus building (forming a Technical Document by Expert Working Group) 2. a) ICH parties consensus on Technical Document b) Draft guideline adoption by Regulators 3. Regulatory consultation and Discussion (wide ranging) 4. Adoption of Harmonised guideline 5. Implementation List the different directorates of the Health Product and Food Branch of Health Canada. - Answers - Therapeutic Products Directorate (responsible for regulating drugs, medical devices, and clinical trials) - Marketed Health Products Directorate (post-market surveillance) - Biologics and Genetic Therapies Directorate (similar to therapeutic products, but with biologics) - Health Products and Food Branch Inspectorate (compliance monitoring, verification, investigation, establishment licensing) - Food directorate - Natural and Non Prescription Health Products Directorate - Policy Planning and International Affairs Directorate - Veterinary Drugs Directorate ~List~ common regulatory skills. - Answers - Communication - Analytical - Science-based - Project management - Sensitivity (Confidential Approval strategies, work within regulations) List the key responsibilities for regulatory affairs. - Answers 1. Strategy (obtain regulatory approvals as quickly as possible) 2. Submissions (negotiate best label for appropriate patients) 3. Labelling (ensure post-approval compliance) When are clinical trial applications (CTA) required to conduct a study in Canada? - Answers When a trial is conducted with: - a medicinal product not authorized for sale - an authorized product where use is outside its approved parameters (new indication, patient population, dosage, route of administration, etc.) List the different types of market submissions. - Answers New drug submission (1 year to review, or 7 months if priority review). Supplemental new drug submission (1 year to review). This is completed when adding a new indication, changing dosage form, etc.