Drug Development Immersion

Drug Development Immersion

  • December 08, 2020 - December 09, 2020
  • Time : 09:00 am - 03:30 am EDT
  • Price : $1325 USD
  • Instructor Name: Kenneth Olivier, PhD
  • Course Level: Level 1 - Foundational

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Drug Development Immersion is a two-day, intensive course that explores the regulatory, commercial, and scientific factors behind bringing a drug successfully to market. Discussion features both small molecule drugs and biologics. Our instructor illustrates the corporate decision-making process with personal accounts, giving participants unique insight into strategic development. Learn from an industry expert what it takes to get a molecule from the bench into the marketplace.  

 
 
 
Who should attend

Appropriate for those without a science background who need a foundational understanding of the drug development process. Ideal for anyone who works in finance, human resources, law, marketing, business development, project management, administrative support, supply chain, research development, non-clinical, clinical, quality assurance, regulatory affairs, policy, government relations and manufacturing.

Please note: All live, online master courses are recorded and made available to registrants for two weeks. Can make all six hours of a class? Catch up or review the content the same day the course is run. 

 

 
 
 
 
In Partnership With

Takeaways
  1. Criteria for preclinical studies to support first in human clinical trials
  2. Fluency in clinical development terminology and acronyms
  3. In-depth look at the FDA and EMA regulatory process and sponsor interactions
  4. Rationale, special considerations, and study designs for each of the four clinical trial phases
  5. Understanding of the launch process, life cycle management, and post-approval drug safety monitoring
 
 
 
 
In Partnership With

Logistics

Course Delivery:

All instructor-led virtual courses will be presented on Zoom. To access the course on Zoom, log into your Biotech Primer account in the upper right-hand corner of the website. You will choose a username and password when you registered. On the day of the course, log in and go to "User Dashboard" found in the dropdown box under your "My Profile" link. The Zoom link will be available 5 minutes before the course begins. Click on the orange "View Course" button and enjoy your course.

Course Materials:

Course materials will be available on your dashboard. You will be given access to a portal where you will be able to view the course materials. Please note the course material will remain on the Biotech Primer portal and you will not be able to download or print these materials. However, you will have access to these materials whenever you log into your Biotech Primer account.

Course Certificate:

Once you have completed your course, your certificate will be available on your dashboard.

Breaks:

There will be a 10-15-minute break between each section. You will be given a 45-minute break for lunch.

Refund Policy:

All courses and products are final sale. If you cannot attend a course, you may send someone in your place by notifying Emily Sullivan at sullivan@biotechprimer.com no later than one week prior to the start of the class as we will need to reset the ZOOM account. Questions?

For this course: Emily Sullivan sullivan@biotechprimer.com

Customized training questions: Stacey Hawkins stacey@biotechprimer.com

 
In Partnership With

All instructor-led virtual courses will be presented on Zoom. To access the course on Zoom, log into your Biotech Primer account in the upper right-hand corner of the website with the username and password you chose when you registered for the course. Once logged in, go to "User Dashboard" found in the dropdown box under your "My Profile" link. The Zoom link will be available 5 minutes before the course begins. Click on the orange "View Course" button and enjoy your course.

Our ideal number of participants is 25-35.

We have a diverse audience in experience, education, and job description. Attendees range from C-level executives to manufacturing shift-workers; those new to the industry to season veterans who may find themselves in a different position or with a new company. This mixed of backgrounds extends the learning for all since everyone has something to contribute to and learn from the group.

The class begins promptly at 9:00am. There will be a 10-15-minute break between each section. You will be given a 45-minute break for lunch. Classes end at 3:30pm.

You need a computer with internet access and a built-in mic or headphones. 

All course materials are kept on the Biotech Primer portal which you will have access to indefinitely. Course materials may include an electronic PDF copy of all presented slides and activities; some courses include a glossary of biotech terms or a list of commonly used acronyms. 

Once you register for a class, course material is available on your Biotech Primer account dashboard. You are given access to a portal where you are able to view the course materials. Please note the course material will remain on the Biotech Primer portal and you will not be able to download or print these materials. However, you will have access to these materials whenever you log into your Biotech Primer account.

Our instructors are dynamic, industry-experienced experts. In fact, this is what sets us apart from other training organizations – our instructors! Anyone can “learn the presentation”- but our instructors can handle your most difficult questions. Our engaging Biotech Primer instructors “edu-tain” you with their own personal war stories.

We do not provide credit hours, however if an organization has access to accreditation, we are certainly willing to sign needed documents to get someone their credit hours.

Once you have completed your course, your certificate will be available on your dashboard.

All courses and products are final sale. If you cannot attend a course, you may send someone in your place by notifying Emily Sullivan at This email address is being protected from spambots. You need JavaScript enabled to view it. no later than one week prior to the start of the class as the Zoom account will need to be reset.

In Partnership With

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Drug Development Immersion Live Online Course Materials

Other Dates & Locations for this Course

$1325
October 21, 2020 - October 22, 2020
Live Online-Simon Tulloch -
 
 
 
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Recording Master Class

$795
Drug Development Immersion is an intensive course that explores the regulatory, commercial, and scientifi...