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Advanced eCTD Submissions

 
  April 06, 2011
Pharma Development and Business
  
     
 
The Regulatory Affairs Professionals Society., Long Beach, CA
20-22 July

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research has required electronic submissions in eCTD format since 1 January 2008 and as part of the most recent version of the Prescription Drug User Fee Act (PDUFA IV) is implementing a single electronic review environment for all FDA Centers by 2013. In addition, Health Canada has implemented an electronic review environment for eCTD submissions and the European Medicines Agency (EMEA) has required eCTD format for Centralized Procedure applications since the beginning of last year (1 January 2010). Some regulatory authorities in Europe have implemented all electronic review environments ahead of this deadline and are refusing to accept paper submissions for review. All regulatory authorities who receive eCTD submissions are reporting serious problems with lack of compliance with the electronic format and difficulty navigating the electronic files that comprise an eCTD, which are preventing them from conducting their review.

Designed to build upon the foundation provided in RAPS’ Preparing Compliant eCTD Submissions Workshop, this interactive, hands-on advanced training seminar will provide the experience of compiling an eCTD submission in the research and development phase, repurposing the content for submission to multiple regulatory authorities, and the challenges and benefits of using document granularity over a drug submission’s lifecycle. Region-specific experts will teach participants about the detailed contents of all modules of the eCTD, the differences in Module 1 for the US, Canada, Europe, and Japan, and how regional differences impact Modules 2 through 5. Attendees will also learn how eCTD submissions in the research and development phase differ from those for marketing applications.

By participating in this workshop, you will not only know how to strategically prepare submissions in the US, Europe, Canada, and Japan, but you will assess and improve submission processes, workflow, and teamwork to achieve less stress and cost to your organization.



Learning Objectives

Upon the conclusion of this program, participants should be able to:

  • Describe the differences in regional requirements for FDA, Health Canada, EMEA, and MHLW
  • Use granularity in document content to prepare INDs in eCTD format
  • Use granularity and lifecycle to prepare marketing applications in eCTD format
  • Develop a table of contents for an eCTD submission with a goal of simultaneous global submissions
  • Understand the direction global regulatory authorities are taking to standardize on the eCTD format and the strategic implications for their companies


NEW Program Additions!

  • Hands-on eCTD publishing experience
  • Compile an eCTD application with multiple submission sequences in compliance with US FDA guidances and specifications
  • Clone the submission sequence 0000 for modification to comply with EMEA eCTD specifications for Centralised Procedure
  • Validate and view the applications against relevant ICH and agency guidances and specifications
 
 
Organized by: Regulatory Affairs Professional Society
Invited Speakers:

Antoinette Azevedo, president, e-SubmissionsSolutions.com, founded the organization in an effort to advise biotechnology and pharmaceutical companies on the use of technology to manage regulatory and controlled documents and publish electronic submissions and registrations. Azevedo's clients range from large, international pharmaceutical companies to small, virtual biotechnology companies. Previously, Azevedo was director of west coast operations for Liquent and principal consultant in CSC Consulting life sciences practice. Azevedo’s experience ranges from developing strategies for document management and electronic publishing, to implementing fully-validated systems accepted by regulatory authorities worldwide.

Ted Hanebach, RAC, director, regulatory standards, CanReg Inc., is an expert in document management and electronic regulatory submissions specifically in XML and open source applications in regulatory standards, document management and data transfer. Hanebach participated in Canadian Therapeutic Products Directorate’s Electronic Standards for Transmission of Regulatory Information (TPD ESTRI) and eCTD working groups and is a member of the validation, document management and e-submissions subcommittees of the Drug Information Association’s Special Interest Area Communities and Regional Information Systems Sharing (RISS) eCTD Lifecycle group. Previous experience includes development, technological management and instruction of manufacturing processes. Hanebach was an instructor in information technology and regulatory standards in regulatory affairs at Humber College, School of Health Sciences in Toronto.

Dominique Lagrave, MA, PharmD, senior director, regulatory operations and innovations, Novo Nordisk, has more than 10 years experience in regulatory. Lagrave began his career at Laboratoires Galderma in France, where he was a regulatory affairs manager and led innovative programs to support electronic submissions in Venezuela and Australia. As a regulatory specialist for a leading submissions publishing vendor, Lagrave consulted for more than 20 companies worldwide assisting them in implementing regulatory publishing tools and processes to support electronic Common Technical Documents (eCTD). He has given more than 30 presentations at key conferences and webinars, and is a member of the Pharmaceutical Research and Manufacturers of America Electronic Regulatory Submissions (PhRMA ERS) group, eCTD subgroup and Regulated Product Submissions (RPS) working group. Lagrave holds a PharmD and a master’s degree in International Regulatory Affairs from the University of Paris.

Deanna Murden, president, ePharmaCMC LLC, has more than 18 years of drug development and regulatory experience in the pharmaceutical industry. Murden’s experience includes global drug development strategy, regulatory chemistry, manufacturing and controls (CMC), and lead health authority liaison for major product approvals worldwide. Murden is actively engaged in regulatory policy and is an industry leader on strategic aspects of eCTD standards and practices for CMC dossier management and compliance, bringing a holistic view to the organization’s operations and management of complex CMC storage and retrieval data systems. Murden is a graduate of two executive education programs from the University of Michigan Ross School of Business.

Emily Onkka, director, Cadence Pharmaceuticals Inc, serves as the head of regulatory operations and document management, and is a frequent presenter on eCTD. Her background in the biopharmaceutical industry includes previous positions with Sirion Therapeutics, Applied Molecular Evolution (AME)/ Eli Lilly and Company and Santarus Inc, where she has grown her experience with a host of specialized software. Onkka has extensive experience in eCTD organizational implementation and project management, as well as in the preparation and maintenance of eCTD NDA and IND submissions. She has a history of building and leading highly effective teams that achieve competitive efficiency in regulatory operations and document management practices.

Hans van Bruggen, Msc, director of Qdossier, has many years of practical regulatory experience in the pharmaceutical industry. Van Bruggen led the successful submission and validation of the first eCTD for an initial Marketing Authorisation Application worldwide for a new chemical entity. He has a wealth of experience, specializing in first time right eCTD lifecycle management and has built up a solid reputation within the pharmaceutical industry and agencies.
 
Deadline for Abstracts: 13 July
 
Registration:
REGISTRATION FEESRegister by 29 JuneRegister after 29 June
RAPS Member$1,540$1,690
Nonmember*$1,740$1,890
Multiple Members**$1,440 each$1,590 each
Multiple Nonmembers*$1,640 each$1,790 each
Government/Nonprofit Member**$1,040 each$1,190 each
Government/Nonprofit Nonmember**$1,240 each$1,390 each

* The above nonmember fees include RAPS membership for 12 months for qualified applicants. By registering you acknowledge that you have reviewed and understand the membership qualifications and accept membership with the Regulatory Affairs Professionals Society.

** Multiple registration fees require three or more participants from the same company to submit individual registration forms at the same time via fax, mail or email to the RAPS Solutions Center. Individuals requesting the government/nonprofit rate must submit their completed registration form by fax or email.

Registration Deadline: Advance registration (online, mail, and fax) will be accepted until 13 July 2011 unless meeting capacity is reached; after 13 July 2011, please contact RAPS Solutions Center at +1 301 770 2920 ext. 200 or raps@raps.org for registration options.

Cancellation Deadline: 29 June 2011
E-mail: acallery@raps.org
 
   
 
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