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WCBP 2019: Workshop Information
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Over the past twenty-two years, we've learned that different subject matter can be best shared through different workshop formats.
This year, WCBP will feature three different styles of workshops to enhance discussion of key topics of interest.
Discussion at workshops, roundtables, plenary and parallel sessions is critical to the success of our meeting. With these varied workshop formats, we hope that you will get even more from WCBP 2019.
 
The Standard Format

This is the workshop you usually think of as being associated with WCBP. Industry and regulatory agency co-leaders focus on generating discussion over the entire period of the session. As with all workshop formats, audience participation is critical to its success.

The Plen-shop Format

The "Plen-shop" format incorporates additional background information to help steer the conversation. In these sessions, one or more short presentations will be followed by intensive discussion. It’s not a plenary session, it’s not a workshop - it’s a Plen-shop!

Hot Topic Workshop
In addition to the pre-determined workshop topics, one standard workshop topic will be chosen on-site by WCBP 2019 attendees.The hot topic workshop allows attendees to suggest and vote for a topic of their choice and we will provide skilled facilitators, whatever the topic!


ICH and Non ICH Workshops

This year the ICH and Non-ICH workshops will not be held during the four workshops sessions, but will instead take place during the Roundtable sessions.

Tuesday, January 29, 2019 - 08:45 - 10:15
Plen-shop: ICH Countries: Regulators' Thoughts on Harmonization Successes and Challenges - Grand Ballroom

Wednesday, January 30, 2019 - 11:15 - 12:30
Plen-shop: Current Regulatory Trends and Hot Topics for Non-ICH Markets- Grand Ballroom


Prior Knowledge Workshop

 The prior knowledge workshop will be held on Tuesday, January 29 from 16:00 - 17:15 in the Grand Ballroom. 
Roundtable Session 1 will also take place during this time.

Tuesday, January 29, 2019 - 08:45 - 10:15
Standard: 
Prior Knowledge: What's in it For Me?


Workshop Session 1: Tuesday, January 29, 2019 – 17:30 – 18:45

Standard: Particles in Injectable Formulations: Risks and Control Strategies - Chinese Room

Standard:Multi-attribute Methods: Now That We Can Measure It, What Does It Mean? - District Ballroom

Plen-shop: Regulatory Considerations for Advances in Technologies like mRNA Vaccines - Palm Court Ballroom


Workshop Session 2:Wednesday, January 30, 2019 – 14:15 – 15:30


Standard:CQA and Process Characterization: Are You Doing what Everyone Else is Doing?Output from an IQ Consortium Working Group- Chinese Room

Standard:Linking Biology to Chemistry to Enable Process Optimization - District Ballroom

Standard:Qualifications of New Working Cell Banks- Grand Ballroom

Plen-shop: Blood Products – Issues Related to Potency Assay Standardization - Palm Court Ballroom


Workshop Session 3:Thursday, January 31, 2019 – 11:30– 12:45


Standard:Qualification of Reference Materials to Sustain the Product Lifecycle - Chinese Room

Standard: Controlling Raw Material Variability – Do Today’s Practices Meet Current & Future Challenges? -District Ballroom

Standard:Control Strategies for Cell and Gene Therapy Products - Grand Ballroom

Standard:Patient-centric Stability and Expiration Dating - A Global View- Palm Court Ballroom


Workshop Session 4:Thursday, January 31, 2019 – 14:15 – 15:30


Hot Topic Workshop: Topic TBD - Chinese Room

Standard:Microbial Requirements for Marketing Applications - District Ballroom

Standard:Closed System Transfer Device (CSTD) Use with Drug or Biological Product - Grand Ballroom

Standard:Next Generation Sequencing: The Range of Applications of NGS Technology - Palm Court Ballroom

 

 


 

more Calendar

9/17/2019 » 9/20/2019
Mass Spec 2019

9/29/2019 » 10/2/2019
CE Pharm 2019

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