ComplianceOnline

Submissions to a regulatory agency involve more than just writing of applications. They also encompass strategy, editing, publishing and systematic tracking of key information. Through formal lectures, case studies, and hands-on exercises, new and experienced regulatory professionals will learn how to interpret regulations and guidance documents to produce submissions that comply with the requirements and are clear to the reviewers.

In this practical course, which is designed to help participants to acquire the knowledge and insight needed to understand and begin to construct core U.S. drug and biologics submissions, including Investigational New Drug (IND), and Investigational Device Exemptions (IDE) applications. Participants also will gain experience with tools that help manage timelines and sections needed from contributors.

Learning Objectives:

  • Identify the required regulations and guidance documents for drug and device submissions
  • Use regulations and guidance documents to outline and construct drug and device submissions
  • Formulate a working knowledge of regulatory submissions, publishing, and style guides
  • Create checklists that encompass timelines and sections needed from contributors
Seminar Fee Includes:
Lunch
AM-PM Tea/Coffee
Seminar Material
USB with seminar presentation
Hard copy of presentation
Attendance Certificate
$100 Gift Cert for next seminar

Areas Covered:

  • Contents of IND and IDE
  • Regulatory requirements for IND and IDE application process
  • Submissions to IND or IDE to the FDA
  • Establishing communications with FDA
  • Type of FDA meetings
  • Amendments to IND and IDE applications
  • Progress reports for IND and IDE

Who will Benefit:

  • Project Managers
  • Clinical Research Associates
  • Data Managers
  • Project Team Leaders with limited direct regulatory experience
  • Grant Administrators
  • Regulatory Associates
  • Quality Assurance specialists
  • Manufacturing, Clinical, and Pre-Clinical Personnel which will be contributing to the IND/IDE or want to learn more about IND/IDE applications process
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Day 01(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration. Meet & Greet.
  • 9:00 AM - 11:00 AM:
    FDA Division Information. Overview of Submissions Process and Assembling Application: creating the Table of Contents, timing of submission/timelines, contributions from other departments, editing, style guides, templates, supportive documents, QA for the submission.
  • 11:00 AM - 12:00 Noon:
    Overview of Investigational Drug Application (IND) format and contents.
  • 12:00 Noon - 1:00 PM: Lunch.
  • 1:00 PM - 2:30 PM:
    Preparation for IND Submission. Routine IND Submissions: Assembling clinical, non-Clinical, CMC, etc. data for FDA drug applications.
    • Tracking the Submissions: Creating the index history an issues log.
  • 2:30 PM - 3:00 PM: Refreshments Break.
  • 3:00 PM - 4:30 PM: Preparation for meetings with FDA.
    • Types of FDA Meetings: Type A, B and C;
    • Pre-IND, Phase I, Phase II, End of Phase II, requesting the meeting, preparing the meeting package, meeting minutes.
Day 02(8:30 AM - 4:30 PM)
  • 8:30 AM - 8:59 AM: Registration, Meet & Greet.
  • 9:00 AM - 11:00 AM:
    • IND Maintenance: Annual Reports, Safety Reports and Investigator Brochure updates, protocol and informational amendments, Investigator change notifications.
    • Special situations for IND submissions: Fast track, orphan drug designation, special protocol assessment.
  • 11:00 AM - 12:00 Noon:
    Overview of device classes, significant and non-significant risk determinations.
  • 12:00 Noon - 1:00 PM: Lunch.
  • 1:00 PM - 2:00 PM:
    • Investigational Device Exemption (IDE) content and application process, regulatory requirements and best practices.
    • Strategies for new device application submissions with FDA depending on the class of the device.
  • 2:00 PM - 2:30 PM:
    IDE maintenance: supplements, amendments, safety and annual reports. Additional types of device studies: Extended access programs and Humanitarian Device Exemption (HUD).
  • 2:30 PM – 2:45 PM: Refreshments Break.
  • 2:45 PM – 3:45 PM:
    • Group work on the case study.
    • Case Study: “Investigational New Drug Application Preparation”.
  • 3:45 PM - 4:30 PM: Discussion of the Case study and Closing remarks
Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure
Peggy J. Berry,

Peggy J. Berry
MBA, RAC,President & CEO, Synergy Consulting (Ex-FDA Official)

Peggy J. Berry, MBA, RAC, is the President & CEO at Synergy Consulting where she provides consulting services to companies in all aspects of drug development. She also provides group and one-on-one training in drug development, regulatory affairs and project management topics. Prior to founding Synergy Consulting in 2015, she was Vice President of Regulatory Affairs at Insmed (2/2015-5/2015) where she was responsible for the development and implementation of global regulatory strategies and the management and oversight of the regulatory affairs department. Prior to Insmed, she was Vice President of Regulatory Affairs and Quality at Amarin (3/2009-2/2014). She has also held a variety of senior level positions at Dyax (5/2006-3/2009), MGI Pharma (now Eisai; 7/2005-5/2006), AstraZeneca (10/2001-7/2005), and Dey Pharma (now Mylan; 12/1997-10/2001). She has also held Regulatory Affairs roles within two clinical contract research organizations (ILEX Oncology and Cato Research Ltd; 1992-1997) and has worked in review divisions at the FDA (1985-1992). In addition, Ms. Berry consults for a number of companies in the regulatory and quality area, conducts a number of training courses, and is active in the Regulatory Affairs Professionals Society. She is the editor of the 2010 book "Choosing the Right Regulatory Career" (RAPS, MD) and author of the 2011 book "Communication & Negotiation" (RAPS, MD).

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$1,299.00

Seminar One Registration

December 4-5, 2018, Tampa, FL
(Registrations till October 25, 2018 - $1299)
(Registrations after October 25, 2018 - $1599)

$5,999.00
$7,794.00 (23%)*

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Special Group Discount Register for Six attendees

December 4-5, 2018, Tampa, FL
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Your registration fee includes the workshop, all course materials and lunch.


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Payment:
Payment is required 2 days before the date of the conference. We accept American Express, Visa and MasterCard. Make checks payable to MetricStream Inc. (our parent company).

Cancellations and substitutions:
Written cancellations through fax or email (from the person who has registered for this conference) received at least 10 calendar days prior to the start date of the event will receive a refund - less a $300 administration fee. No cancellations will be accepted - nor refunds issued - within 10 calendar days before the start date of the event.

On request by email or fax (before the seminar) a credit for the amount paid minus administration fees ($300) will be transferred to any future ComplianceOnline event and a credit note will be issued.

Substitutions may be made at any time. No-shows will be charged the full amount.

We discourage onsite registrations, however if you wish to register onsite, payment to happen through credit card immediately or check to be submitted onsite. Conference material will be given on the spot if it is available after distributing to other attendees. In case it is not available, we will send the material after the conference is over.

In the event ComplianceOnline cancels the seminar, ComplianceOnline is not responsible for any airfare, hotel, other costs or losses incurred by registrants. Some topics and speakers may be subject to change without notice.

Attendance confirmation and documents to carry to the seminar venue:
After we receive the payment from the registered attendee, an electronic event pass will be sent to the email address associated with the registrant 5 working days before the seminar date. Please bring the pass to the venue of the event.

Conference photograph / video:
By registering and attending ComplianceOnline conference, you agree to have your photographs or videos taken at the conference venue and you do not have any objections to ComplianceOnline using these photos and videos for marketing, archiving or any other conference related activities. You agree to release ComplianceOnline from any kind of claims arising out of copyright or privacy violations.

Offers:

  • Early bird seats are limited and based on first-come, first-serve.
  • Multiple offers cannot be combined.
  • Location:

    Tampa, FL
    (Venue to be announced shortly)

    December 4-5, 2018

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    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
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    • Free event pass
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    For more details and other sponsorship options at this event, please contact Event Manager: customercare@complianceonline.com or call: +1-650-238-9656

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