CMC

Summary

We all need to find faster and more efficient routes in the development of new drugs and the support of approved products. This forum provides a unique peer-to-peer learning experience. The practical approaches for the selected topics are seldom the subject of publications, and often deal with material and experiences that cannot be published.  Thus, the verbal peer-to-peer discussions are the most effective and rapid means of information sharing. This year’s topics are:

  • Topic 1 - Established Conditions and Module 2
  • Topic 2 - Comparability: Science and Guidance on Protocols
  • Topic 3 – Post-approval Change Management
  • Topic 4 - Control Strategies for Early-stage Clinical Supplies

Using a parallel breakout session format, all four topics are discussed in a small group format to ensure all participants have space to ask and answer questions, share experiences, and learn as peers.

Participants of this event will:

  • Educate and advance Chemistry, Manufacturing, and Controls (CMC) topics of current interest.
  • Understand the current CMC scientific and regulatory challenges for the proposed topics of current interest.
  • Analyze current trends in CMC regulatory for the proposed topics.
  • Learn and share successful strategies for drug development and regulatory approval.
  • Participate in cross-functional/cross-discipline dialog and understanding between industry and health authorities.
  • Promote peer-to-peer knowledge, networking, and community formation.

Registration Information

Register Here

Registration Type Registration Fee
Member $150
Non-member $200

All registrations must be received by May 25, 2018.

AAPS is not accepting on-site registration for this event.

Registration Fee Includes:

    • Breakfast and Lunch

Cancellations

Cancellations must be submitted to AAPS in writing by May 25, 2018 and faxed to +1.703.243.5582 or sent via email to registration@aaps.org.

Cancellation requests received by this date will be refunded less a $50 administrative fee for members and non-members. Refunds will not be issued for requests received after May 25, 2018. All approved refunds will be issued within 30 days of submission.

Substitutions

Registrant substitutions from the same company may be submitted in writing by May 25, 2018 without penalty. If the membership status of the substitute differs from that of the original registrant, a refund or additional charge may apply. Send substitution requests to registration@aaps.org or fax to +1.703.243.5582.

Housing

AAPS does not have an official room block for this event. However, we recommend attendees consider the following hotels if they are in need of overnight accommodations:

Hotel Name Distance 
Grand Summit Hotel  2 miles
Debary Inn  2 miles
Hilton Garden Inn Springfield  4 miles
Hilton Short Hills  6 miles
Embassy Suites by Hilton Berkeley Heights  10 miles
The Westin Governor Morris, Morristown  11 miles
Courtyard Basking Ridge  15 miles


















Program Committee


Nina Cauchon, Ph.D.,
Amgen Inc. 

Sigita Zibas, Ph.D.,
Celgene

Oksana Golycheva,
   Johnson & Johnson   

James S. Bernstein, Ph.D.,
Live Oak Pharmaceutical Consulting