ComplianceOnline

The Society of Clinical Research Associates (SOCRA - www.SOCRA.org) accepts documentation of candidate participation in continuing education programs for recertification if the program is applicable to clinical research regulations, operations or management, or to the candidate’s clinical research therapeutic area. This program offers 13 hours of CE credit.

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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Martha French,

Martha French
Consultant, Martha French Consulting

Martha French have over 28 years combined experience in biomedical research and regulatory affairs. As Vice President of Regulatory Affairs at Bellicum Pharmaceuticals she was responsible for the management of all US and European pre-market regulatory activities for novel CAR and TCR T cell therapies that incorporate molecular switches. As Director of Regulatory Affairs at InGeneron Inc., she was responsible for the management of European and US regulatory activities for medical devices that prepare autologous regenerative cell therapies at point of care. At Introgen Therapeutics, Martha led US and European pre-market regulatory activities for three novel biologic products. She was responsible for the filing of the first gene therapy Biologics License Application (BLA) to the FDA and filed two gene therapy Marketing Authorization Applications (MAA) to the EMA. At Valentis, Inc. (formerly Gene Medicine Inc.), Ms. French led the Analytical Sciences core teams in support of the company’s cardiovascular, oncology and PEG protein programs. With long tenure at Lark Technologies, as Vice President of Operations, she managed the DNA sequencing, library screening, restriction enzyme mapping and PCR services. Ms. French graduated from Carroll University with a Bachelor of Science in Biology, taught Regulatory Affairs for the 2008 Human Gene Therapy course at the University of Texas Graduate School of Biomedical Sciences.

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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.

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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.

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  • Testimonials

    See What People Say About Us

    These topics were most valuable to me - "eCTD Publishing, tips Qc, tips for document preparation, QC checklists, source document checklist". It was interactive and had great exercises, handouts etc. I liked all of it.

    Regulatory Affairs Ops Specialist, Retrophin

    All the modules and content of each module is very informative. Overall content is good and informative. The presenter Peggy Berry is very knowledgeable and lead the discussions of the seminar in a very interactive way.

    Associate Director, Bayer Pharmaceuticals

    Years of experience and practical experience information from trainer was very helpful. All content was helpful.

    Regulatory Affairs and Compliance Specialist, Becton Dickinson

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