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CMC Strategy Forum Summer 2019
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Thank you to all who participated and helped make CMC Strategy Forum 2019 a success!

Forum Co-chairs: 
Joseph Kutza, AstraZeneca 
Ingrid Markovic, Genentech, a Member of the Roche Group 
Cecilia Tami, CDER, FDA 
Chikako Torigoe, CBER, FDA 
Kimberly Wolfram, Biogen  

Scientific Organizing Committee: 
Sally Anliker, Eli Lilly and Company 
Basim Hilal, F. Hoffmann-La Roche Ltd. 
Christine Moore, Merck & Co., Inc. 

The basic concepts of Lifecycle Management discussed in ICH Q12 including Established Conditions, Post-Approval Change Management Plans, and the Product Lifecycle Management document have been introduced and discussed at multiple conferences including a CMC Strategy Forum in July 2016 (Change Happens). As the guidance moves forward to adoption and implementation the practical aspects of implementing these concepts may be quite challenging. The USFDA announced an Established Conditions (EC) Pilot Program to assess and help to refine proposed ECs and identify agreed upon ECs at approval thus recognizing the need to learn more about how EC’s may be leveraged by industry. This CMC Forum will go beyond the high-level Q12 concepts to focus on how regulatory affairs groups within industry will handle the details of submitting, tracking, and maintaining Q12 proposals and what quality and technical teams will need to consider as they try to make these concepts come to life.  The forum will also explore concerns from regulatory authorities as they look to receive and review submissions containing some or all of the of Q12. Are we all practically, realistically, ready for ICH Q12? How will we manage all of the non-ICH markets in the age of ICH Q12? Do you have questions and concerns about how your company or regulatory agency will be able to implement and leverage the core concepts? If so, this CMC Strategy Forum is for you.

Questions that will be addressed: 

With regards to ICH Q12: 
   ~ What are the key opportunities for industry and regulators?
          ~ What gaps is the guidance meant to address?
   ~ What are the key challenges for industry and regulators? 
   ~ Is it possible to only use certain elements and not others? 
   ~ What are the risks or efficiencies gained by not following this guidance? 
   ~ If a focused industry only leads to different established conditions and different data requirements for PACMPs and different post-approval expectations in each
      ICH market, is it really worth it?   
   ~ How will regulators receive training on the new concepts? 
   ~ What have companies done that has worked well? What have regulators seen that they like? 
   ~ What does this mean for inspections or the PQS? 



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