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EDATA INTEGRITY REPORT & APYX PRESENT…

 

A COMPLIMENTARY, COMPREHENSIVE AUDIOCONFERENCE SERIES…

 

eCTD – A Roadmap for Small to Mid-size Biopharmaceutical and Device firms

 

 

Session One: Authoring for CTD – What it means for your Authors and your Organization

Date: April 26 @ 1:30 PM EST

 

·         Templates and the importance of standards

·         Authoring training and support – tweak the process but keep Authors focused on authoring not administration

·         CTD granularity and its impact

·         Why format matters (and has real value $$$)

·         Format vs. content reviews

·         Document management – It’s role in authoring and publishing

 

 

Session Two: Creating an eCTD – Lessons learned through experience

Date: May 30 @ 1:30 PM EST

 

·         Division of labor – Process and technology when it comes to eCTD

·         The tipping point – Achieving the right balancing between execution and tracking

·         An eCTD creation methodology – Used, proven, cost-effective

·         Document and dossier re-use – Plan for it to achieve it

·         New Developments – submitting to FDA via the electronic gateway and a little about an emerging standard, RPS

 

 

Session Three: Managing the eCTD Lifecycle with an Eye towards Continuous Improvement

Date: June 28 @ 1:30 PM EST

 

·         Once eCTD, always eCTD – handling your routine submissions in eCTD format

·         Working with a partner – Ability to respond to tight timelines and is it a big deal if you change your mind

·          The FDA’s perspective – Their latest thinking on lifecycle management

 

  

The audioconferences will be moderated by EDIR Editor Michael Causey. They’ll be lead by Ken VanLuvanee, CEO and founder of Apyx, Inc.

 
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About Your Speaker, Apyx CEO Ken VanLuvanee
 With over 15 years experience in the life sciences industry, working both within and as a consultant to the industry, Ken has helped define and lead efforts within Regulatory Affairs, Medical Affairs, Clinical, and Pharmacovigilance related to efficient, compliant use and management of controlled documents.  He has specific expertise in Electronic Document Management, Electronic Publishing, Computer Systems Validation, and the implications of implementing electronic components within regulated business processes. 
 He has both participated on and managed global publishing teams in the creation of submissions in multiple paper and electronic formats to several health authorities.
 Ken is a globally recognized expert in electronic document management and electronic publishing.  As such, he was invited to participate in a working group sponsored by Health Level 7 (HL7), an FDA sponsored and ANSII accredited standards development organization, charged with developing a future standard for transmission of electronic information between healthcare companies and global regulatory agencies.
 He is an active Drug Information Association member, with leadership and involvement in multiple Special Interest Activity Communities (SIACs), including the Regulatory Submission Publishing SIAC and the Records Management and Archiving SIAC.  Ken routinely supports DIA through volunteer speaking and program committee membership.
 Under Ken’s leadership, Apyx has grown from a start-up organization in 2002 to an organization with a 78% annual growth rate and clients on three continents.  Apyx has established itself as a solid, significant contributor in within the biopharmaceutical industry.
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