Rx-to-OTC switch refers to the transfer of proven prescription drugs (Rx) to nonprescription, OTC status. Rx-to-OTC switch is a data-driven, scientifically rigorous, and highly regulated process that allows consumers to have OTC access to a growing range of medicines. For a medicine to be granted OTC status, it must have a wide safety margin and be effective, and must bear understandable labeling to ensure proper use. Rx-to-OTC product movement is consistent with a long-term lifecycle strategy strategy that many brands have successfully employed for over two decades and more brands are likely to follow in the near future.
This self paced study module provide effective understanding of this strategy in detailed and explain in step by step how brands should go Rx to OTC. Detailed practical process is explained in the course.
Who should attend this course?
- Those who are in regulatory affairs and related department
- Professionals from drug discovery development and pharmaceutical strategic management professionals
- Anyone requiring an overview of drug regulatory affairs
Duration: Access Available for 7 days
Course Code: KPE-C-054
Course Fees: 5850 Indian Rupees / 90 USD
Course Syllabus | Course Flow | Content
|Part 1||Overview of Drug Discovery process||Lecture – 1 | PDF STUDY MODULE |Test – 1||1.30 HR|
|Part 2||Introduction to Strategic Management||Lecture 2 | Test – 1||2.00 HR|
|Part 3||Rx Vs. OTC – Introduction||Lecture – 1 | PDF STUDY MODULE |Test – 1||1.00 HR|
|Part 4||Characteristic OTC pharmaceuticals||Lecture – 1 | PDF STUDY MODULE |Test – 1||1.00 HR|
|Part 5||What is Prescription to OTC switch||Lecture – 1 | PDF STUDY MODULE |Test – 1||2.00 HR|
|Part 6||Regulatory and Strategic issues in Rx to OTC switch||Lecture – 1 | PDF STUDY MODULE |Test – 1||2.00 HR|
|Part 7||FAQs – Rx to OTC Switch||Lecture – 1 | PDF STUDY MODULE |Test – 1||1.00 HR|
|Part 8||Case Studies||Lecture – 1 | PDF STUDY MODULE |Test – 1||2.00 HR|
|Part 9||Other Evergreening Strategies||Lecture – 1 | PDF STUDY MODULE |Test – 1||1.00 HR|
Certificate will be issued at the end of successful completion of the course.