ACG-FDA Visiting Fellowship Program
Application submission for the ACG-FDA Visiting Fellowship Program is now open.
ACG-selected gastroenterology fellows will integrate into the daily activities of the Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER), Division of Gastroenterology and Inborn Error Products (DGIEP). Fellows will gain valuable experience in drug/medical device registration and approval process and observe the interaction between the FDA, academia, and industry. Ancillary activities will include cross-FDA Center activities, such as interaction with colleagues in the Gastroenterology and Renal Devices Branch at the Center for Devices and Radiological Health (CDRH). Fellows will be expected to pursue an independent project aligned with their research interest and career development.
ACG-FDA Fellowship Program Goals
- Develop an understanding of the interchange between industry and FDA as drug and device development programs are examined by regulators and modifications are negotiated in an ongoing dialogue.
- Interact with medical officers and scientists from various disciplines within and outside DGIEP.
- Develop an understanding of the technical language and science of drug and device development and clinical trial design for registration purposes.
- Familiarize participants with the mission and history of the FDA.
Fellow must complete a report describing experience and benefits gained from the fellowship experience. In lieu of the report the fellow may perform an independent project (such as research, manuscript, webinar, patient education brochure, etc.) on any aspect of their rotation. The report or project will be presented to FDA prior to the completion of the fellowship and at an appropriate forum during the ACG Annual Meeting. The fellow will also present the findings of the report/project at the ACG Annual Meeting following the completion of the visiting fellowship.
In addition, selected fellows will be invited to serve as an ad hoc member of the ACG FDA Related Matters Committee and participate in all teleconferences and committee meetings.
Ultimately, fellows who have participated in this program will bring the knowledge gained to their own future work and interactions with professional colleagues to facilitate expeditious development of new drugs and/or devices.
Fellows in their second or third year of training will be eligible to participate. The application process begins in the first or second year of fellowship.
Third year fellows should plan to finish this program and present their experiences during the ACG Annual Meeting (October) prior to graduating.
The fellowships will be awarded by the ACG FDA Related Matters Committee for a period of one month or longer.
The selected applicant will receive a monthly stipend of $3,000.00, which includes airfare, living expenses and meals. Fellows are responsible for their lodging and meals but ACG staff will provide assistance. An additional $1,000.00 will be provided for travel and related expenses to the ACG Annual Meeting for their presentation.
Review and Selection Process
The ACG FDA Related Matters Committee will review applications and will select awardees. Awards made by the ACG FDA Related Matters Committee will be based upon the applicant’s credentials and endorsement from fellow’s course director.
Completed applications and all correspondence should be mailed to the ACG office address: ACG, 6400 Goldsboro Road, Suite 200, Bethesda, MD 20817 and directed to the FDA Related Matters Committee staff liaison, Brad Conway.
Questions regarding this program should be addressed to Brad Conway at 301-263-9000 or firstname.lastname@example.org.
September 10, 2015.
The FDA requires a specific application for this fellowship program. In order to avoid duplicative application forms, and to help ACG better assess your application, ACG requires that interested applicants complete the “FDA ORISE Fellowship Application Form” pursuant the instructions below.
Once you complete the FDA ORISE Application, DO NOT SEND TO THE FDA. PLEASE SEND ALL APPLICATION MATERIALS DIRECTLY TO THE ACG OFFICES: ACG, 6400 Goldsboro Road, Suite 200, Bethesda, MD 20817
Please follow these “how to complete the application” instructions when completing the FDA ORISE Application.
How to Complete the Application
ACG requests that you include the information as part of the FDA application in order to review each qualified applicant. As such, PLEASE BE SURE TO INCLUDE THE FOLLOWING IN THE APPLICATION (some questions are self-explanatory):
|Requested Information in FDA Application:||Answer must include:|
|“Requested FDA Center/Division”||“Division of Gastroenterology and Inborn Error Products (DGIEP) in the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA)”|
|“Requested Start Date”||“To be determined”|
|“Most Recent Degree”|
|“Current Mailing Address”|
|“List members of scientific staff at FDA with whom you have had contact”||(if any)|
|“Describe the educational and professional goals you expect to achieve as a result of participating in this program”||Applicant shall state the reasons for seeking this fellowship and goals of the experience, including the applicant’s previous experience and specific areas of interest within the FDA. Applicant should also state the knowledge/experience the applicant hopes to achieve upon completing this fellowship program.|
|“How did you learn about this program?”||“The American College of Gastroenterology”|
|“Attach resume or curriculum vitae (CV)”||Remember to include FDA-requested information as part of your CV: academic history, employment record, relevant research experiences.|
|“Remember to include transcripts”||Medical school transcripts are sufficient.|
|“Demographic Information”||This is optional but is used as a means to ensure diversity in the FDA fellowship programs.|
|“Reference #1”||This must be from your Program Director (thesis/dissertation advisor). The program director must include his/her email address along with the requested signature, mailing address, and telephone number.The Program Director shall include information on how he/she has known the applicant and pertinent information that sets this applicant apart from others applying for the fellowship.The program director must also complete the “personal characteristics” and “scientific capabilities” sections of the application reference material as well.|
|“Reference #2”||This reference must come from a fellow of the American College of Gastroenterology (FACG). The reference must also complete the “personal characteristics” and “scientific capabilities” sections of the application reference material as well.|
Draft Schedule for the Visiting Fellowship
In addition to daily interactions with members from DGIEP, the Fellow will participate in the following activities:
- Didactic sessions (slides available and videotaped)Selected lessons within the Modules from the New Reviewers Blended Learning Program, potentially including an introduction to FDA, CDER, and drug lifecycle, the pre-IND and IND review process, and post marketing activities.Selected lessons from the Introduction to Clinical Review Training Series (slides available and videotaped), potentially including an introduction to CMC/Pharm Tox/Clin Pharm, Pharm/Tox 101, Labeling Basics, Pediatric Drug Use and Development, Maternal Health and Drug Development, FDAAA-Related Safety Activities and the Role of the Medical Officer.
- Attend scheduled internal and industry meetings throughout the month.
- Attend monthly Medical Officer rounds, weekly divisional meetings, and weekly CDER scientific seminars.
- Participate in the planning and attend public advisory committee meeting(s) (if scheduled).
- One-on-one meetings with medical officers and scientists from the following disciplines (as appropriate):
- Clinical Outcome Assessments Staff
- Labeling Development Team
- Division of Pharmacovigilance, Office of Surveillance and Epidemiology
- Orphan Products/Rare Diseases
- Office of Scientific Investigation
- Gastroenterology and Renal Devices Branch, Center for Devices and Radiological Health (CDRH)
- Complete a report or independent project to be presented at FDA prior to completing of fellowship and at the appropriate forum during the ACG Annual Meeting.
- A liaison from the FDA Related Matters Committee will be appointed to serve as mentor and interact with the fellow and his/her Preceptor during the fellowship.