Drug Development Immersion
- May 10, 2023 - May 11, 2023
- (Time : 12:00 pm - 06:30 pm EDT)
- Price : Not available - SOLD OUT
- 188 E Blaine St Ste 150, Seattle, WA 98102 View Map
- Instructor Name: Janet Rose Rea
- Course Level: Level 1 - Foundational
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Drug Development Immersion is an interactive course that explores the regulatory, commercial, and scientific factors needed to bring a drug successfully to market. The discussion features both small-molecule drugs and biologics. Our instructors illustrate the corporate decision-making process with personal accounts, giving participants unique strategic development insights. Learn from an industry expert what it takes to get a molecule from the bench into the marketplace.
Drug Development Immersion was developed for the non-science professional who works within or services the biopharma industry and needs to become familiar with the preclinical and clinical development process.
- Fluency in essential terminology and acronyms used in clinical development.
- An in-depth look at the FDA and EMA regulatory process and sponsor interactions.
- Criteria for preclinical studies to support first-in-human clinical trials.
- Rationale, special considerations, and study design for both traditional and non-traditional
clinical trial phases. - Understanding of the launch process, life cycle management, and post-approval drug safety
monitoring.
What People Are Saying
"This course was immensely beneficial for me. As a project manager with no pharma experience, I now feel better equipped to perform my job functions, ask insightful questions, and mitigate risks much earlier on before they become issues."
Appropriate for those without a science background who need a foundational understanding of the drug development process.
Ideal for anyone who works in finance, law, marketing, human resources, business development, project management, IT, administrative support, supply chain, research development, non-clinical, clinical, quality assurance, regulatory affairs, policy, government relations and manufacturing.
Past participants include:
- Venture capitalists, bankers, analysts, financial managers
- Insurance brokers, real estate professionals
- Patient advocacy group staff, disease foundation members
- Policymakers, lobbyists, attorneys
- Consultants, public relations specialists, journalists
- University administrators, research institute support staff
Location: Life Science Washington Office, 188 E Blaine St Ste 150, Seattle, WA 98102
Entry Protocol: Please have your license ready to show at reception.
Parking: Free onsite
Refreshments: Coffee, tea, and water bottle station provided. Please bring your own water bottle.
Lunch: A lunch is provided. If you have any special dietary needs please plan on bringing your own lunch as we cannot guarantee how the food is prepared as we are using a 3rd party caterer.
Dress: Please plan on dressing in layers as we cannot control the temperature in the room.
What to bring to class: Log into your Biotech Primer dashboard to download or print the electronic workbook as you will need access to this for course activities. You may want to bring a pen and paper to take notes. Please ensure your laptop is fully charged.
