ICH M10 Public Consultation Workshop










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Summary


At this event, we will discuss, review, and present data and case studies illustrating areas of concern from both industry and regulatory perspectives on the newest draft of the M10 technical document.

The goal of this workshop is to bring together bioanalytical stakeholders from industry and health authorities, as well as academia, consultants, and other interested parties, to discuss and provide collective feedback to the draft guideline.

This event relies heavily on participation from attendees with session chairs and moderators driving the discussion on the ICH M10 draft guideline. Evenings are reserved for speakers and moderators to recap the discussions and report back the summary to the attendees, as well as for opportunities for direct engagement with industry and regulatory key opinion leaders on BA key issues.

This event provides a venue and unique opportunity for industry and regulators to convene and discuss the ICH M10 technical document released for public consultation.

Participants in this event will have an opportunity to:

  • Gain an in-depth understanding of the ICH M10 on BMV.
  • Engage in a robust discussion on the topics covered in the guideline.
  • Discuss the areas of concern or areas requiring further clarity and participate towards the consensus feedback on ICH M10.


Registration Information

 

Registration Type Early Registration
(March 18-May 20) 
On-site Registration
(May 21-June 10)
Member $1,195 $1,495
Non-member $1,395 $1,695
Student $150 $250

Registration Fee Includes:

    • Access to the session slides post event
    • Continental Breakfast Daily
    • Buffet lunch Daily
    • Evening Reception 

Cancellations

If you cancel registration on/before, May 24, 2019 you will be refunded your registration fee minus an administration fee of $50.

No refunds will be given for “no shows” or for cancellations received on or after May 25, 2019.

Refunds will be credited back to the original credit card used for payment, or if paid by check, a refund check will be issued to the original payer within 30 days of submission.

Substitutions

Registration substitutions from the same company may be submitted in writing to [email protected] at any time without penalty. If the membership status of the substitute differs from that of the original registrant, a refund or additional charge at the current rate may apply.


Housing Information

Location

Sheraton Silver Spring 
8777 Georgia Avenue 
Silver Spring, MD, 20910

A special rate of $199/night is available for a limited number of rooms until May 20, 2019.

Click here to reserve your room now!

Driving & Metro Information

Featured Hotel Amenities

  • Self- parking at $18 per day
  • Complimentary wifi
  • Complimentary shuttle to/from Silver Spring Metro Station

Location

Approximate distances:
  • 4 blocks - Silver Spring Metro Station (Red line)
  • 6 miles - Downtown Washington, DC
  • 11 miles - Ronald Reagan Washington National Airport (DCA)
  • 22 miles - Baltimore/Washington International Thurgood Marshall Airport (BWI)
  • 29 miles - Washington Dulles International Airport (IAD)










Program Committee


Brian Booth, Ph.D.,
U.S. Food and Drug Administration

Faye Vazvaei, 
Roche

Eric Fluhler, Ph.D.,
  Bioanalytical Compliance Associates, LLC

Heather Myler, Ph.D.,
PPD Ltd

Eric Woolf, Ph.D.,
Merck