Developing a drug product, biological or device has become more complex and costly than ever, and with a typical program spanning over many years, few people ever get to experience the entire drug development lifecycle of a product; yet knowing the requirements and interactions across each phase of drug development is critical to ensuring a successful submission, marketing, extensions and evergreening of a product. This Drug Development cycle course will consist of 9 different eLearning modules that will be about 45 minutes each:
Module 1: Overview of Drug Development - Available
Module 2: Research: the first step in identifying the target - Coming soon
Module 3: Non-Clinical Development or how to Prepare for First-In-Man - Coming soon
Module 4: Human Pharmacology - Coming soon
Module 5: Therapeutic Exploratory - Coming soon
Module 6: Therapeutic Confirmatory - Coming soon
Module 7: Registration: Filing - Coming soon
Module 8: Launch to Market - Coming soon
Module 9: Post-Marketing Activities - Coming soon
Documents and materials related to this course are included
Globally recognised certificates awarded after test completion
This course has been granted PharmaTrain Recognition
By better understanding the entire Drug Development lifecycle, and the trials and regulations surrounding drug development, pharmaceutical professionals will have a greater chance of success, whilst minimizing poor decision-making. Ultimately, understanding the entire drug development process, rather than its parts, will give you a better understanding of the basic requirements needed to obtain approval from a regulatory authority and bring the product to the market, hopefully helping to reduce time to market and maximise value and quality.This course will take you on a journey over the entire Drug Development Lifecycle and provide you with a general understanding of all the phases of drug development as well as the typical timing, cost, and resources needed to develop a product. A key component of this training highlights the critical points in the drug development process where enough data or scientific knowledge is gained to make the critical decision as to whether to move onto the next phase of development.
Being able to understand the entire journey of developing a drug product, from product concept until post-marketing activities and learn to anticipate what will be needed at each phase of development and what questions should be answered at each phase.
Understand the concept of “critical path” and milestones and decision points, leading to faster decision-making.
Learn the importance of identifying your key stakeholders, such as commercial, non-clinical, clinical, regulatory, and technical, and how to bring them together towards a common goal.
Who should attend
Biopharmaceutical professionals looking to better understand the entire journey of Drug Development, especially for the ancillary departments such as legal, HR or IT
Those looking to move into a different phase of Drug Development or looking to move into a more senior role where the overview of product development is necessary
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