Course Description:

Course "Preparing IND Submissions for Conventional and Orphan Products" has been pre-approved by RAPS as eligible for up to 12 credits towards a participant's RAC recertification upon full completion.

All sponsors of clinical trials in the US for drug and biologics have to first file an Investigational New Drug (IND) application with the FDA containing extensive information in support of the proposed clinical trial. The IND application contains all available preclinical and clinical testing information, and all manufacturing information for the investigational product, along with clinical protocol, informed consent template, investigator’s brochure and other relevant information. For special situation such as orphan products additional considerations might apply regarding all aspects of the IND from protocol design to the background preclinical data and details of manufacturing information. Failure to submit a satisfactory IND could lead to FDA imposing a clinical hold on the clinical trial in turn adding additional expense and delay to a clinical trial.

Attending this workshop is a good step toward making sure that your next IND meets FDA requirements and gets a “Safe to Proceed” letter from the FDA within 30 days from submission. Also discussed will be special situations such as INDs for orphan drugs and botanical drugs. The session topics are arranged in a logical chronology to ease the understanding of complex issues and possible solutions. This workshop contains a collection of practical tips from the trainer’s extensive IND submission experience.

Who will Benefit:

  • Sponsors of INDs
  • Orphan drug developers
  • Supervisors, and lead workers in Regulatory Affairs
  • Project management personnel
  • Senior management executives (CEO, COO, CFO, etc)
  • Manufacturing managers, supervisors & personnel
  • Clinical and preclinical laboratory managers
  • People investing in FDA-regulated product development projects

Course Outline and Approximate Times:

Day 1


Day 2

  • 8:00 – 8:30 AM: Registration
  • 8:30 – 10:00AM: Lecture 1: Overview of FDA’s IND requirements
    • Historical overview of IND regulations
    • Types of INDs
    • Commercial verses investigator-led INDs
    • 10 essential sections of an IND
    • What information to be included and what to be avoided
    • Overview of practices at FDA regarding review and management of INDs
    • Considerations for an orphan drug
  • 10:00 – 10:15AM: Break
  • 10:15 – 12:00 noon: Lecture 2: Orphan Drugs and other Special Categories
    • Determination of an orphan drug eligibility
    • Orphan drug designation request
    • Incentives of an orphan drug designation
    • Fast-track designation
    • Small business designation at the FDA
  • 12:00 – 12:45PM: Lunch
  • 12:45 – 2:15PM: Lecture 3: The Content and Format of an IND
    • Key elements of an IND application
    • Collecting information supportive of the IND application including product background (CMC), preclinical and clinical testing, clinical protocol, etc
    • Creating proposed clinical development plan, scientific rationale, and clinical practices to be followed.
    • Using non-IND information, publications and marketing experience from other countries
    • Special products: orphan drugs, botanical drugs,
    • Best practices for format and content arrangement
    • Managing the tone of the content
    • Granulating the IND content for optimum presentation of information
    • List of common mistakes and tips to address the same
  • 2:15 – 2:30PM: Break
  • 2:30 – 3:30PM: Lecture 4: Logistics of IND Submission: Best Practices for timely good quality IND application
    • Evaluating adequacy for available information in support of a clinical trial
    • Creating an IND submission strategy
    • Sectional IND: Parallel creation individual sections of a IND
    • Collecting cross-reference information
    • Practical tips for compiling individual pieces into a full application
    • Electronic verses paper IND submissions
    • Role of sponsor’s authorized representative and US agent
  • 8:30 – 10:00AM: Lecture 5: CMC Section of an IND
    • Elements of the CMC section of an IND
    • Collecting manufacturing and characterization data
    • Raw material, drug substance, drug product and packaging information
    • Stability studies
    • Label, storage, shipping and handling information
    • Import and export of investigational material
    • Special considerations for orphan and botanical products
  • 10:00 – 10:15AM: Break
  • 10:15 – 12:00 noon: Lecture 6: Presenting Pre-clinical and Clinical Information in the IND
    • Preclinical studies needed by FDA to support an IND application and NDA
    • Trends in preclinical data collection
    • Strategic assumptions and implications: maximizing using minimal model
    • Acceptance of non-IND and non-US clinical trials by FDA
    • Using published literature for preclinical and clinical data in support of an IND
    • Special considerations for orphan and botanical products
  • 12:00 – 12:45PM: Lunch
  • 12:45 – 2:15PM: Lecture 7: FDA Meetings and Other Regulatory Interactions
    • Logistics of a pre-IND meeting with the FDA
    • Best practices for preparing a pre-IND packag
    • Do’s and don’ts of pre-IND meetings
    • Interacting with the FDA project manager after IND submission
    • Post-IND discussions with the FDA: Managing verbal and written comments
  • 2:15 – 2:30PM: Break
  • 2:30 – 3:30PM: Lecture 8: Best Practices for Maintaining an IND with the FDA
    • IND annual reports
    • Amending clinical protocols and informed consent, manufacturing information, providing additional preclinical and clinical information, etc
    • Adverse event reporting
    • Adding new clinical protocols to or creating a new IND for each new protocol
    • Change in sponsor, vendors, investigators, manufacturers, clinical sites, etc.
    • Written and verbal request for comments and FDA meetings for further guidance
    • Suspending, reopening, closing and withdrawing an IND

Meet Your Instructor:

Dr. Mukesh Kumar
Senior Director, Regulatory Affairs, Amarex Clinical Research

Dr. Mukesh Kumar, leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( His key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA. In addition, he has had made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. Dr. Kumar is a PhD in Biochemistry and has worked as a research scientist at the NIH, Baylor College of Medicine, Houston, and premier institutions in India. He is a certified regulatory affairs professional by the Regulatory Affairs Professional Society, USA.

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What past attendees say:

I enjoyed the practical answers and lessons learned as shared by the presenter. Grateful for the sharing of presentation material (soft copy). Thanks to ComplianceOnline for timely response and communication. Variety of choices is extensive good and easy to register.
- Manager, Process Optimization, Prolong Pharmaceuticals, LLC

Excellent instructor and he was easy to follow and I like the thorough and thoughtful answers of my questions.
- Senior Scientist, CCS Associates

Instructor is very knowledgeable and good in explaining regs and guidance. Information provided along with soft copy of slide is a great idea and very helpful.
- Sr. QA Manager, Theravance

Overall a good general overview. The amount of interaction between the participants and presenter was good.
- Asst. Director QA, Clinical Packaging, Abbott Labs

GMP expectations was the most valuable topic for me. Face to face interaction and networking was good.
- Director of Pharmacy, Pfizer New Haven Clinical Research Unit

Speaker’s knowledge was higher than I had hoped.
- Director, BioMed IRB

For me the whole event was very good. I had no knowledge of the topic prior to this seminar. The presentation was excellent and the speaker was very knowledgeable and respectful.
- Quality Assurance Specialist, Therapure Biopharma Inc.


The RAPS Regulatory Affairs Certificate Program offers unique curricula to round out your regulatory knowledge and professional skills with a focus on medical devices and/or pharmaceuticals. Whether you are looking to gain a better understanding of the regulated health product industry or bolster your credibility and resume or curriculum vitae, the Regulatory Affairs Certificate Program is a valuable resource in your pursuit of professional advancement.

After completion of course "Preparing IND Submissions for Conventional and Orphan Products" RAPS certificate will be issued to attendee.

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