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eCTD Submissions of 2253's

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Transitioning from paper to eCTD for 2253 Submissions?
The updated 2253 draft guidelines for Ad Promo submissions, is an example of the FDA encouraging sponsors to adopt practices that will benefit industry as a whole.

A step in the right direction.
Submitting video, audio and images as DVD media by mail in an age of such impressive computing power at low cost is much too tedious for sponsor and Agency.

Modernization.
By updating the specification, updating the technology, and encouraging a rethinking of internal processes, the FDA is moving toward a more modern business reality.

Published in: Health & Medicine
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eCTD Submissions of 2253's

  1. 1. Pyxa  Solu*ons,  LLC   Transi*oning  from  paper  to   eCTD  for  2253  Submissions  
  2. 2. 2   The  Industry  is  shiAing..   10/6/16   M1  ini*a*ve       The  updated  2253   dra7  guidelines  for   AdPromo   submissions  is  an   example  of  the   FDA  encouraging   sponsors  to  adopt   prac*ces  that  will   benefit  industry  as   a  whole.     A  step  in  the  right  direc*on   SubmiJng  video,   audio  and  images   as  DVD  media  by   mail  in  an  age  of   such  impressive   compu*ng  power   at  low  cost  is  much   too  tedious  for   sponsor  and   Agency.   Moderniza*on   By  upda*ng  the   specifica*on,   upda*ng  the   technology,  and   encouraging  a   rethinking  of   internal  processes,   the  FDA  is  moving   toward  a  more   modern  business   reality.   A  “MORE  MODERN  BUSINESS”  REALITY  FOR  2253’S   ..are  you  shiAing  with  it?  
  3. 3. 3  10/6/16   Quan*fying  the  shi7  in  2253  submissions     from  paper  to  eCTD   Since  the  Office  of  Prescrip*on  Drug  Promo*on  (OPDP)  started  accep*ng   electronic  submissions  in  June  2015  through  the  middle  of  February  2016   (in  the  first  8.5  months),  it  has  received  400  AdPromo  submissions   containing  more  than  1,000  promo*onal  pieces*.   Since  then  (in  the  3  months  that  followed)  these  numbers  have   doubled**.     As  of  now  (end  of  April  2016),  approximately  a  couple  dozen   companies  have  already  made  the  transi*on**.   **Source: Confidential to Pyxa Solutions LLC ** NOTE: The “couple dozen companies” is inclusive of partnerships and subsidiaries. *Source: presentation from Roberta Szydlo from the ODPD during the DIA Marketing Pharmaceuticals 2016 conference
  4. 4. 4  10/6/16   Why  some  Companies  are  deciding  to  shi7  to   eCTD  before  the  dra7  guidance  is  final  and  before   the  mandated  deadline   Proac*vely  shiAing  from   paper  to  eCTD  for  2253   Submissions     Strategic     Considera*ons   Opera*onal   Considera*ons   FDA     Considera*ons   Compliance     Considera*ons  
  5. 5. 5  10/6/16   Strategic  Considera*ons   Why  companies  are  shi7ing  now…     Reviewers  like  it!     An  overwhelming  #  of   reviewers  in  OPDP   that  review  2253’s  and   associated   promo*onal  materials   like  to  receive  it  in   eCTD  format   Improves  manageability   The  granular  format  of   eCTD  AdPromo   submissions  improves   manageability  and  helps   companies  more  clearly   and  succinctly  organize   their  informa*on   Open  Dialogue  w/  Agency       The  agency  is  seeking   open  dialogue  and  is   providing  some  leeway   for  companies.  They   want  companies  to   no*fy  them  of  formats   that  fall  outside  the   guidance   Influence  Change     Commen*ng  period  is   over,  however  FDA  is   s*ll  taking  comments   on  board  and  may   update  the  guidance   with  clearer   statements  to  remove   ambiguity   Save  *me  and  effort   The  ability  to  submit   grouped  submissions   will  save  *me  and   effort  by  allowing  one   submission  to  mul*ple   applica*ons  that  share   the  same  informa*on.   Beher  insight!   With  AdPromo  being   eCTD,  companies  can   easily  link  to  the   various  applica*ons  in   order  to  have  beher   oversight  and   improved  decision   making.  
  6. 6. 6  10/6/16   Opera*onal  Considera*ons   Why  companies  are  shi7ing  now…     Submit  high  volume   2253s   Opportunity  for   companies  to  develop   streamlined  processes   to  submit  high  volume   2253s  electronically   over  the  electronic   submission  gateway   (ESG)   Lifecycle  Opera*ons   Take  advantage  of  the   convenience  and   visibility  afforded  when   performing  Lifecycle   opera*ons  in  eCTD.  (e.g.   If  part  of  the  original  submission   is  rejected,  the  sponsor  may  file   an  amendment  with  only  the   missing  or  rejected  component,   instead  of  submiJng  the  en*re   2253)   Reduced  Manual  Effort   Preparing  Ad  Promo   submissions  would   not  require  as  much   manual  effort.  There   would  be  no   coun*ng  of  hard   paper  copies  and   burning  media  to   discs.   Faster  Publishing-­‐Review     Publishing  is  faster   and  cheaper.   Submission  through   the  gateway  allows   reviewers  to  assess   submission  rapidly.   This  process  is  faster   then  Paper.    
  7. 7. 7  10/6/16   FDA  Considera*ons   Why  companies  are  shi7ing  now…     Alignment   with   Submission   Process   Alignment with submission process for other submissions in CDER Improve   processing   efficiency   Due to extensive metadata collection allows submission information to be automatically populated into tracking software to improve processing efficiency BeVer   Insights   Electronic search and filtering capabilities. FDA has more insight, the FDA can now do searches of the submission to extract the information they need. Faster  and   More   Efficient   Faster and more efficient delivery to the reviewer - With the new Module 1, the ability to accept Form 2253 submissions in eCTD format via the ESG Ability  to   receive  high   volume   2253’s   Opportunity for streamlined processes and ability to receive high volume 2253s from companies electronically over the electronic submission gateway (ESG) Availability   for  All   Reviewers   Submission is available for all staff to see, therefore secondary review and consultation of other offices is more efficient Product   Applica*on   Info  Quickly   Available   Product application information is in one location, will be quickly available for all reviewers as needed. Ability to receive eCTD 2253 and non-2253 submissions over same electronic submission gateway (ESG) Receive  all   Submissions   through  ESG    
  8. 8. 8  10/6/16   Compliance  Requirements:  FDA  Guidance  &  Landscape   Indicated  by  the  use  of  the  words  MUST   and  REQUIRED,  this  document  is  NOT   subject  to  the  usual  restricAons  in  FDA’s   good  guidance  pracAce  (GCP)  regulaAons   FDA  is  not  including  this  standard  language  in   this  guidance  because  it  is  not  an  accurate   descrip*on  of  all  the  effects  of  this  guidance.   This  guidance  contains  both  binding  and  non-­‐ binding  provisions.  Insofar  as  this  guidance   specifies  the  format  for  electronic  submissions   pursuant  to  sec*on  745A  of  the  FD&C  Act  it  will   have  binding  effect.     FDA  Guidance's  ordinarily  contain  standard   language  explaining  that  guidance's  should  be   reviewed  only  as  recommenda*ons  unless   specific  regulatory  or  statutory  requirements   are  cited.     In  sec*on  745A  of  the  FD&C  Act,  congress   granted  explicit  statutory    authoriza*on  to  FDA   to  specify  in  guidance  the  format  for  the   electronic  submissions  required  under  that   sec*on.  
  9. 9. 9  10/6/16   Compliance  Requirements:  Upcoming  Requirements   In  OPDP’s  draL  guidance,  FDA  is  proposing   pharmaceuAcal  companies  submit  promoAonal   materials  for  human  prescripAon  drugs  to   OPDP  using  its  electronic  common  technical   document  (eCTD)  format.     OPDP  has  tradi*onally  required  companies   to  submit  promo*onal  materials  to  it  for   review  using  Form  FDA  2253—a  paper-­‐ based  form.       FDA  explains  "As  of  that  date,  paper  hard   copies  will  no  longer  be  accepted  for  such   submissions”.   In  the  mean*me,  firms  are  "strongly   encouraged"  by  FDA  to  begin  submigng   promo*onal  materials  using  the  eCTD   immediately.   This  requirement  is  changing,  eCTD   submissions  for  2253  will  be  required  two   years  aAer  the  guidance  document  is   finalized.  
  10. 10. 10  10/6/16   Compliance  Requirements:  Risk  of  Non-­‐Compliance   FDA  explains  "As  of  that  date,  paper  hard   copies  will  no  longer  be  accepted  for  such   submissions”.   Not  a  point  for  nego*a*on  with  the  FDA.       Companies  who  do  not  comply  with  the   upcoming  eCTD  requirements  for  submiJng   their  2253s  will  find  themselves  in  a  posi*on   where  their  submissions  will  be  rejected  or   returned  with  comments  (as  would  any   submission  made  to  the  FDA  that  does  not   follow  the  regula*ons).       This  will  result  in  delays  with  FDA  review  and   therefore  use  of  the  materials  in  the  field.        
  11. 11. 11  10/6/16   Value  Proposi*on   Once  the   guidance  is  final,   there  will  be  NO   other  op*on  but   to  implement  the   eCTD  process   Advance  planning   allows  all  risks  to   be  mi*gated  and   resources  to  be   addressed  prior   to  required  “go-­‐ live”  date   Good  Standing:   Following  FDA’s     strong   recommenda*on  to   begin  submiJng   promo*onal  materials   using  the  eCTD   immediately   Documents   available,  easily   accessible,   traceable  and   reportable   (throughout  the   lifecycle)     Preparing for and implementing (pilot or full go-live) a 2253 eCTD process before it is mandated by FDA Implemen*ng     the  eCTD  Process  in   advance  will  ensure   the  process  is   implemented   effec*vely  and   efficiently  prior  to   mandated     deadline  
  12. 12. 12  10/6/16   Risks  that  can  be  avoided   Vendors  not   providing   materials  in  the   correct  format  –   Regulatory  can   take  this  on   Mis-­‐ management  of   life  cycling  of   the  pieces  (and   maintenance  of   lifecycle)   Poor  *meline   management  to   ensure  pieces   are  ready  for   use       Under   es*ma*on  of   resources  /  skills   when  managing   electronic   submissions   As  part  of  the  end-­‐to-­‐end   eCTD  process  ensure   measures  are  put  in  place  to   manage  revised  pieces  or   discon*nua*on  of  a  piece.         As  part  of  the  end-­‐to-­‐end  eCTD   process  ensure  format  and   standards  for  promo*onal  pieces   are  established  and  communicated   to  vendors  –  HAVE  A  BACK  UP  -­‐  if   you  can  not  get  vendors  to  take  this   on  effec*vely  and  efficiently.     As  part  of  the  end-­‐to-­‐end  eCTD   process  ensure  *melines  are  clearly   communicated  to  all  func*ons   involved  in  the  process  and  the   turn-­‐around  *me  for  “re-­‐work”  is   understood  so  that  submissions  are   not  delayed  .   As  part  of  the  end-­‐to-­‐end   eCTD  process  ensure   resources  (people  and  tools)   are  in  place  to  accommodate   the  required  changes  from   paper  to  eCTD.     ConsideraAon:  Eliminate  large  scale  risk  by  implemenAng  a  small  scale  pilot  (for  one  or  more  “not  so   acAve/criAcal”  products  to  ensure  the  process  is  streamlined  and  miAgaAon  plans  are  considered  prior   to  full  scale  implementaAon  
  13. 13. 13  10/6/16   Industry  Best  Prac*ce  –  How  Pyxa  Can  Support     ✓ ✓ Establish  a  vendor  guide  to  ensure  all  Vendors  providing  promo*onal  materials  are  following  the   required  format  /  standards  (ONLY  if  Vendors  will  be  managing  this  for  you)   Incorporate  language  in  Vendor  agreements  to  ensure  vendors  are  contractually  obligated  to     abide  by  the  templates  /  standards  guide  provided  to  them  (embed  in  the  process)  -­‐  (ONLY  if   Vendors  will  be  managing  this  for  you)     ✓ Ensure  Regulatory  QC  performed  on  materials  received  from  Commercial  is  inclusive  of  checks  for   submission  readiness  (built  within  a  checklist  to  ensure  consistency  with  each  review)   ✓ Establish  internal  standards  (e.g.  leaf  *tles  and  file  names;  placement  loca*on  etc.)  –  as  applicable   ✓ Establish  a  lifecycle  management  approach  to  maintaining  promo*onal  pieces   Establish  an  end-­‐to-­‐end  cross-­‐funcAonal  2253  eCTD  process  to  ensure  consistent  and   efficient  transiAon  to  meet  the  upcoming  requirements   ✓ Implement  a  pilot  (Test  Submission)  to  fine-­‐tune  processes  before  full  implementa*on   ✓ Determine  if  Vendors  will  provide  promo*onal  materials  in  the  required  format  or  if  Regulatory   Opera*ons  will  re-­‐format  pieces  to  the  necessary  standards    
  14. 14. Contact  US   INFO@PYXASOLUTIONS.COM    

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