ComplianceOnline

The international agreement to assemble all Quality, Safety and Efficacy information for a drug or biologic product into a common format (called the CTD - Common Technical Document) has improved the speed and efficiency for companies working in global development programs and clarified expectations by regulatory bodies. Reformatting for multiple submissions is substantially limited. The CTD has improved the regulatory review processes and enabled implementation of good review practices. The eCTD has increased efficiency for reviewers and improved submission times.

This two day workshop will provide you with an in-depth review of the content and format requirements of the CTD/eCTD. Hands-on activities will include organizing specific study reports and other documents into the CTD, using tools for the project management of the CTD preparation, and pre-publishing an eCTD.

Who will Benefit:

  • Regulatory Affairs
  • Quality Assurance
  • Pharmacovigilance
  • Project Management
  • Regulatory Operations
  • Medical and Technical writers
  • Professionals preparing IND, DMFs, NDAs and other submissions
  • IT Professionals
  • Anyone responsible for providing content for the CTD
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
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Day 01(8:30 AM - 4:30 PM)
  • Registration Process - (8:30 am till 8:45 am)
  • Lecture 1: Overview of the drug development program and source of relevant submission documents
  • Lecture 2: Discussion of the roles and responsibilities for CTD preparation
  • Lecture 3: Review of the CTD format requirements
  • Lecture 4: Discussion on the successful transition from other formats to the CTD
  • Lecture 5: Placement of content into the CTD format; including less obvious items
  • Lecture 6: Review of different requirements across regions (US, EU, Canada)
  • Lecture 7: Implementing tools for the project management of CTD preparation and publishing
Day 02(8:30 AM - 4:30 PM)
  • Lecture 8: Technical requirements for an eCTD submission
  • Lecture 9: Document naming requirements
  • Lecture 10: Building the folder structure
  • Lecture 11: Internal document requirements for the eCTD
  • Lecture 12: Performing "pre-publishing" work for each document
  • Lecture 13: Tools for tracking and managing eCTD content
  • Lecture 14: Performing quality checks on the eCTD
  • Lecture 15: Updating content in the CTD and eCTD (amendments, supplements, variations, etc.)
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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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$1,499.00

Seminar One Registration

August 24-25, 2017, San Francisco, CA
(For Registrations till July 5, 2017 - $1499)
(For Registrations till July 20, 2017 - $1699)
(For Registrations after July 20, 2017 - $1899)

$2,199.00

Seminar One Registration (With 2 Nights Stay)

August 24-25, 2017, San Francisco, CA

$6,799.00
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August 24-25, 2017, San Francisco, CA
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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.

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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.

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Location:

San Francisco, CA
(Venue to be announced shortly)

August 24-25, 2017

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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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