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
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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
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Marina Malikova

Marina Malikova,Ph.D, MSci, MA, CCRA, RAC
Executive Director at Boston University School of Medicine

Dr. Malikova has over twenty years of experience in the clinical research field. She has managed Phase I – IV studies involving investigational drugs, devices and biologics. She has worked on Industry-sponsored and Investigator-initiated trials in the fields of Surgery, Cancer Diagnostics and Interventional Radiology.

Dr. Malikova graduated from the Institute of Biochemistry, Russian Academy of Science, in Moscow, Russia with a PhD in Biochemistry. She also holds a Master’s Degree in Clinical Investigation and Project Management Certification from Boston University.

In her current role as Executive Director, Dr. Malikova manages research efforts in 13 divisions of the Department of Surgery at Boston Medical Center. She is responsible for clinical trials and basic biomedical research operations, quality assurance, risk management, safety monitoring, strategic planning, and macro-management of research programs. She provides guidance and oversight to the Project Managers, Clinical Research Associates (CRAs), Clinical Research Coordinators (CRCs), and laboratory staff. She advises faculty/staff on protocol and informed consent writing; assists with BU IRB applications and submissions; provides oversight for data user agreements, cost coverage analysis and budgets development, contracts and licensing for clinical research; and ensures compliance.

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$1,499.00

Seminar One Registration

August 23-24, 2018, San Francisco, CA

$6,799.00
$8,994.00 (24%)*

Save $2,195.00

Special Group Discount Register for Six attendees

August 23-24, 2018, San Francisco, CA
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Palo Alto, CA 94303
USA

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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

    DoubleTree by Hilton San Francisco Airport
    835 Airport Blvd,
    Burlingame, CA, 94010-9949, USA
    Tel: +1 650-344-5500

    August 23-24, 2018

    How to Reach

    General Driving Directions:

    Directions from San Francisco International Airport, CA: 4.8 mi.
    • Depart from San Francisco International Airport, CA
    • Take ramp left for US-101 South toward San Jose (2.5 mi.)
    • At exit 419B, take ramp right and follow signs for Broadway (0.2 mi.)
    • Turn left onto Broadway (0.2 mi.)
    • Turn right onto Old Bayshore Hwy / Bayshore Hwy (0.1 mi.)
    • Turn left onto Airport Blvd (0.7 mi.)
    • Arrive at Airport Blvd on the right (0.0 mi.)
    Directions from San Jose International Airport, CA: 31.1 mi.
    • Depart Airport Blvd toward Airport Blvd (1.0 mi.)
    • Bear left toward Skyport Dr (0.3 mi.)
    • Keep straight onto Skyport Dr (0.1 mi.)
    • Take ramp left for CA-87 N / Guadalupe Pkwy (0.7 mi.)
    • At exit 9B, take ramp left for US-101 North toward San Francisco (28.6 mi.)
    • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
    • Keep straight onto Anza Blvd (0.2 mi.)
    • Turn right onto Airport Blvd (0.0 mi.)
    • Arrive at Airport Blvd on the right (0.0 mi.)
    Directions from Metropolitan Oakland International: 27.5 mi.
    • Depart Airport Dr toward Airport Dr (0.3 mi.)
    • Turn right onto Alan Shepard Way (0.0 mi.)
    • Turn right onto John Glenn Dr (0.5 mi.)
    • Turn right onto Ron Cowan Pkwy (0.0 mi.)
    • Take ramp left for Airport Dr (0.7 mi.)
    • Turn right onto CA-61 / Doolittle Dr (0.9 mi.)
    • Keep left to stay on CA-61 / CA-112 / Davis St (0.5 mi.)
    • Take ramp right for I-880 South toward San Jose (6.7 mi.)
    • At exit 27, take ramp right for CA-92 West toward San Mateo Br (13.1 mi.)
    • At exit 13B, take ramp right for US-101 toward San Jose / San Francisco (4.1 mi.)
    • At exit 419A, take ramp right and follow signs for Anza Blvd (0.2 mi.)
    • Keep straight onto Anza Blvd (0.2 mi.)
    • Turn right onto Airport Blvd (0.0 mi.)
    • Arrive at Airport Blvd on the right (0.0 mi.)

    Disclaimer: Directions to the venue above have been taken from the hotel website. Attendees are advised to check with the hotel for confirmation of these directions before starting for the venue. ComplianceOnline is not responsible for any inaccuracies in the same.

    Register by phone or need assistance? Call +1-888-717-2436 Register Now Download Brochure

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    Benefits of becoming a Sponsor/Exhibitor/Media Partner:

    • Logo on website, marketing email, branding materials & the registration booth
    • Exhibit Space
    • Free event pass
    • Speaking opportunity
    • Social media campaign

    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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