Barnett International's Core Curriculum courses are comprehensive role-based clinical research training programs designed to provide industry professionals with hands-on training in a dynamic virtual setting. Held four times a year during our “Clinical Research Training Weeks,” courses offer clinical research-focused, performance-based training and core competency development.
Gap Analysis: How to Bridge the Non-Approvable to the Approved Marketing Application
Upcoming Courses
A gap analysis is an assessment tool to help identify differences between “the space where we are and where we want to be.” A gap analysis helps bridge that space by highlighting which requirements are being met and which are not. The tool provides a foundation for measuring the investment of time, money, and human resources that’s required to achieve a particular outcome,such as an approved marketing application. It is with much anticipation and effort that an NDA/BLA is planned and published, as the goal of your company is to get an approved NDA and a marketed product. You implement this goal by creating a regulatory strategy to ensure (with all the factors that are in your control) that the NDA gets approved the first time it is submitted. How do you do this? By performing a gap analysis. In drug development, a gap analysis is the review of each component of a drug development plan,by non-stakeholders or internal stakeholders, at a certain point in time to identify “gaps” in the filing. This gap analysis will ultimately lead to creating a strategy to deal with the “gaps” and reduce the chance of another review cycle.
- Determine what a Target Product Profile and Regulatory strategy documents can look like
- Identify the "tools" needed to conduct a gap analysis from the perspective of: Clinical, Nonclinical, , CMC, Publishing
- Discuss gap analysis fundamentals: Why conduct a gap analysis, How to organize a gap analysis, Choose external experts and consultants to help conduct or review the gap analysis
- Budget and prepare a timeline for the gap analysis (for both large and small companies)
- Bring together all consultant feedback and present finding to the team in an organized and concise manner for risk determination and mitigation planning
- Get the needed information to put together the review package
- Determine what will the final product look like
- Determine who will put the package together and review the final output
- Integrate the findings in the drug development process/regulatory strategy
- Improve your marketing application’s chance of getting approved during its first cycle review
- Any part of the drug development team who wishes to know more about gap analysis and first cycle approval. Regulatory quality assurance, manufacturing, clinical, project management, and pre-clinical personnel will all benefit from this course.
The course will be led by one of the following instructors:
Meredith Brown-Tuttle, R.A.C.
Click here for complete trainer biographies
Day 1: 8:30 a.m. – 5:00 p.m.
- Target Product Profile
- Regulatory Strategy
- Gap Analysis Fundamentals: How, Who, Where, When, Why
- Internal reviews
- External reviews
- Budget
- First cycle approval rates
- How to apply the findings to the current drug development program
- How to maintain the gap analysis
- Hands on exercise: conducting a mock gap analysis
- A mock drug development program will be reviewed, and participation from the attendees will be used to help locate “gaps” to approval. Templates will be provided to the attendees to help produce a gap analysis.
Registration fees include assorted breakfast items that will be available each day ½ hour prior to the start of the seminar. Also included is a Networking Lunch that will be served each training day.
Special rates are available for multiple attendees from the same organization. Contact Elizabeth Andrews at 781-972-5418 to discuss your options and take advantage of the savings.
Click here for our seminar cancellation policy
Barnett International is accredited by the Accreditation Council for Pharmacy Education as a provider of continuing pharmacy education. Participants will receive 7 hours (0.7 CEUs) of continuing education credit for full participation, including the completion of a pre-test, post-test and program evaluation. Barnett International will mail ACPE statements within three weeks of program completion. ACPE# 0778-0000-10-019-L01-P. Released 9/10.
Hold this course at your company!
For more information, contact Naila Ganatra at (215) 413-2471.
