Drug Development Cycle
Book a session
| Date | Product | Location | Price | |
|---|---|---|---|---|
| Module 1 : Overview of Drug Development | eLearning | EUR 100 | Book | |
| If you would like to have this course as an in-house session click here | ||||
About this course
Reasons to attend
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
What's included?
- Documents and materials related to this course are included
- Globally recognised certificates awarded after test completion
Course Description
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.Programme highlight
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.
Learning objectives
- 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
Competencies
This course covers competencies that are part of the ECCRT Competency Framework
- Scientific Concepts & Research Design
- Ethical & Participants Safety Considerations
- Investigational Product Development and Regulation
- Clinical Studies Operations (GCPs or ISO 14155)
- Study and Site Management
- Data Management and Informatics
- Leadership and Professionalism
- Communication
- Teamwork
- Business acumen
Trainers
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