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CMC Strategy Forum: History and Summary Papers
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EUROPE  

13-15 May 2019, Seville, Spain
EMA’s Draft Guideline on Drug-Device Combinations Sheds Needed Light on Expectations for Device Assessment
Click here for summary article.


14-16 May 2018, Noordwyjk, Netherlands
CMC Priorities of EFPIA’s European Biopharmaceutical Enterprises Include ADCs, Drug/Device Combos and Statistics
Click here for summary article.


22-24 May 2017, Killarney, Ireland

9-11 May 2016, Paris, France
A summary article has been published in International Pharmaceutical Quality (August 2017). 
Click here for summary article. 
 
4-6 May 2015, Copenhagen, Denmark

5-7 May 2014, Sorrento, Italy 
A summary article has been published in International Pharmaceutical Quality (August/September 2014)
Click here for summary article. 

6-8 May 2013, Prague, Czech Republic

23-25 April 2012, Berlin, Germany
EMA's Key Biotech Quality Initiatives in Focus at CASSS' 2012 CMC Strategy Forum Europe
A summary article on the EMA's Quality Initiatives has been published in International Pharmaceutical Quality (May 2012).
Click here for summary article.

21-23 March 2011, Barcelona, Spain
Improving Biopharmaceutical Product Quality: Moving Implementation Forward
A summary article on Higher Order Structure has been published in International Pharmaceutical Quality (April 2011).
Click here for summary article.

25-27 May 2010, Vienna, Austria
Challenges Facing Biopharmaceutical Development in the Next Decade
A summary article on Biosimilars has been published in International Pharmaceutical Quality (August 2010).
Click here for summary article.

A summary article on EMA Challenges has been published in International Pharmaceutical Quality (August 2010).
Click here for summary article.

27-29 April 2009, Lisbon, Portugal
CMC Perspectives on Biological Investigational Medicinal Products in Clinical Trials

8-9 April 2008, Paris, France
Staging of CMC Requirements Throughout the Product Development Cycle

8-9 March 2007, Brussels, Belgium
Life Cycle Approach for Specifications
Click here for summary paper. (NOTE: This paper was not published.)

JAPAN

3-4 December 2018, Tokyo, Japan

4-5 December 2017, Tokyo, Japan

5-6 December 2016, Tokyo, Japan
A summary article has been published in International Pharmaceutical Quality (August 2017). 
Click here for summary article. 

9-10 November 2015, Tokyo, Japan
A summary article has been published in International Pharmaceutical Quality (August 2017). 
Click here for summary article. 

8-9 December 2014, Tokyo, Japan
A summary article has been published in International Pharmaceutical Quality (August 2015).
Click here for summary article. 

9-10 December 2013, Tokyo, Japan
A summary article has been published in International Pharmaceutical Quality (February 2014).
Click here for summary article. 

3-4 December 2012, Tokyo, Japan
A summary article has been published in International Pharmaceutical Quality (January 2013).
Click here for summary article.

LATIN AMERICA

12-13 March 2019, Brasilia, Brasil

5-6 September 2016, Mexico City, Mexico

24-25 August 2015, Brasilia, Brasil
A summary article has been published in International Pharmaceutical Quality (November 2015). 
Click here for summary article. 

21-22 August 2014, Brasilia, Brazil

UNITED STATES

July 15-16, 2019 Gathersburg, MD
Practical Aspects of ICH Q12 Implementation 

January 28, 2019 Washinton, DC
Continuous Manufacturing for Biologics 

The Development of Patient-focused Commercial Specifications through Understanding of Clinical Relevance and Criticality of Quality Attributes 

July 16-17, 2018 Gaithersburg, MD 
"Next Generation" Biotechnology Product Development, Manufacturing and Control Strategies 

January 29, 2018 Washington, DC
Phase-appropriate Method Validation Strategies: Policies and Practices to Support Clinical Development 

Prior Knowledge: Learning from our Successes and Failures to Improve Product Development and Manufacturing 

July 17-18, 2017 Gaithersburg, Maryland

Manufacturing, Quality and Regulatory Considerations for Cell & Gene Therapies

January 23, 2017 Washington, DC
Production Cell Line Development and Control of Product Consistency during Cell Cultivation - Myths, Risks and Best Practices
The summary paper has been published in BioProcess International (Volume 16, Number 9, September 2018). 
Click here for summary paper.

July 20-21, 2016 Gaithersburg, Maryland 
Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management
The summary paper has been published in BioProcess International (Volume 15, Number 8,  September 2017). 
Click here for summary paper. 


July 18-19, 2016 Gaithersburg, Maryland
Emerging Strategies in Drug Product Comparability and Process Validation  

January 25, 2016 Washington, DC
NOTE: Both CMC Strategy Forums were cancelled due to the blizzard. 

July 20-21, 2015 Gaithersburg, Maryland
Evolution of Biopharmaceutical Control Strategy Through Continued Process Verification: Technical and Regulatory Considerations
The summary paper has been published in BioProcess International (Volume 15, Number 1, January 2017). 
Click here for summary paper. 

January 26, 2015 Washington, DC
Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs and Regulatory Expectations
The summary paper has been published in BioProcess International (Volume 15, Number 3, March 2017). 
Clickhere for summary paper. 

Current Perspectives on Host Cell Protein Analysis and Control: Science, Risks and Regulations
The summary paper has been published in BioProcess International (Volume 14, Number 8, September 2016). 
Click here for summary paper

July 21-22, 2014 Gaithersburg, Maryland
Effective Management of Contract Organizations: Sponsors, Contract Organizations, Health Authorities and Patients - Keeping the Product Pipeline Moving, Compliant and Available
The summary paper has been published in BioProcess International (Volume 13, Number 9, October 2015). 
Click here for summary paper. 


January 27, 2014 Washington, DC
Accelerated Product Development - Leveraging Combined Industry and Regulator Knowledge to Bring Products to Patients More Quickly 
The summary paper has been published in BioProcess International (Volume 12, Number 11, December 2014). 
Click here for summary paper. 

Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations
The summary paper has been published in BioProcess International (Volume 14, Number 2, February 2016). 
Click here for summary paper. 


July 15-16, 2013 Gaithersburg, Maryland
Biological Product-specific Reference Standard - Best Practices 
The part one summary paper has been published in BioProcess International (Volume 12, Number 3, March 2014).
Click here for summary paper. 
The part two summary paper has been published in BioProcess International (Volume 12, Number 5, May 2014). 
Click here 
for summary paper. 

January 28, 2013 Washington, DC
New Paradigms for Process Validation - A Practical Approach 
The summary paper has been published in BioProcess International  (Volume 11, Number 9, October 2013).
Click here for summary paper. 

Practical Use of Expanded Change Protocols
The summary paper has been published in BioProcess International (Volume 13, Number 3, March 2015).
Click here for summary paper. 

July 16-17, 2012 Bethesda, Maryland
Drug Product for Biological Medicines: Novel Delivery Devices, Challenging Formulations and Combination Products    
The part one summary paper  has been published in BioProcess International (Volume 11, Number 4, April 2013).
Click here for summary paper.
The part two summary paper has been published in BioProcess International (Volume 11, Number 6, June 2013).
Click here for summary paper. 

January 22, 2012 San Francisco, California
Biosimilar Products: Scientific Principles, Challenges, Opportunities  
The summary paper has been published in BioProcess International (Volume 11, Number 10, November 2013).
Click here for summary paper. 

Rapid Pharmaceutical Product Development: Getting Off the Critical Path and onto the Right Path
The summary paper has been published in BioProcess International (Volume 10, Number 11, December 2012).
Click here for summary paper.

August 1-2, 2011 Bethesda, Maryland
Challenges and Considerations for Multiproduct Facility Design and Control for Biologics
The summary paper has been published in BioProcess International (Volume 10, Number 11 (supplement) December 2012).
Click here for summary paper.

January 9, 2011 Washington, DC
A Practical Approach to the Analysis and Immunogenic Potential of Aggregates and Particles
The part one summary paper has been published in BioProcess International (Volume 9, Number 10, November 2011).
Click here for part one.
The part two summary paper has been published in BioProcess International (Volume 9, Number 11, December 2011).
Click here for part two.  

July 19-20, 2010 Bethesda, Maryland
QbD for Biologics: Learning's from the Product Development and Realization Case Study (A-Mab) and the FDA OBP Pilot Program
The summary paper has been published in BioProcess International (Volume 10, Number 8, September 2012).
Click here for summary paper.

January 24, 2010 Washington, DC
Analytical Characterization and Regulatory Considerations for Antibody-Drug Conjugates: Uniting Small Molecule and Biologic Drug Perspectives
The summary paper has been published in BioProcess International (Volume 9, Number 8, September 2011).
Click here for summary paper.

The Role of Higher Order Structure in Defining the Quality of Biopharmaceutical Products
The summary paper has been published in BioProcess International (Volume 9, Number 4, April 2011).
Click herefor summary paper.

July 27-28, 2009 Bethesda, Maryland
Practical Applications of Quality Risk Management
The summary paper has been published in BioProcess International (Volume 8, Number 3, March 2010).
Click here for summary paper.

January 11, 2009 San Francisco, California
Raw Material Control Strategies for Bioprocesses
The summary paper has been published in BioProcess International (Volume 7, Number 8, September 2009).
Click here for summary paper.

July 24-25, 2008 Bethesda, Maryland
Quality by Design - The Next Phase: Approach for Filing the QbD Data and Potential Regulatory Implications
The summary paper has been published in BioProcess International (Volume 7, Number 1, January 2009).
Click here for summary paper.

January 27, 2008 Washington, DC
Extractables and Leachables: Challenges and Strategies in Biopharmaceutical Development
The summary paper has been published in BioProcess International (Volume 9, Number 2, Febuary 2011).
Click here for summary paper.

Current Practices for Assessing the Comparability and Stability of Gene Therapy Products

July 16-17, 2007 Bethesda, Maryland
Quality by Design (QbD) for Biopharmaceuticals
The summary paper has been published in BioProcess International (Volume 7, Number 1, January 2009).
Click here for summary paper.

January 28, 2007 Washington, DC
Binding Assays and Bioassays: What Are Their Roles in Lot Release and Stability Testing?
The summary paper has been published in BioProcess International (Volume 8, Number 6, June 2010).
Click here for summary paper.

Glycosylation of Therapeutic Proteins: Current Understanding of Structure-Function Relationship
The summary paper has been published in BioProcess International (Volume 9, Number 6, June 2011).
Click here for summary paper.

July 20-21, 2006 Bethesda, Maryland
Changing the Paradigm of Process Validation

January 23, 2006 San Francisco, California
Standard Reference Materials for Biopharmaceutical Products: Strategies to Support Product and Method Specifications
The summary review has been published in The Gold Sheet (Volume 40, Number 6, June 2006).
Click here for summary review.

July 25-26, 2005 Bethesda, Maryland
Design and Successful Implementation of a Stability Program for Biotechnology-Derived Products
The summary review has been published in The Gold Sheet (Volume 39, Number 10, October 2005).
Click here for summary review.

January 9, 2005 Washington, DC
Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase and Post Approval
The summary paper has been published in BioProcess International (Volume 6, Number 2, February 2008).
Click here for summary paper.

Lot Release and Characterization Testing of Live-Virus-Based Vaccine and Gene Therapy Products
The part one summary paper has been published in BioProcess International (Volume 4, Number 4, April 2006).
Click here for part one summary paper.
The part two summary paper has been published in BioProcess International (Volume 4, Number 5, May 2006).
Click here for part two summary paper.

July 19-20, 2004 Bethesda, Maryland
Defining Your Product Profile and Maintaining Control Over It: Process-Related Impurities
The summary paper has been published in BioProcess International (Volume 3, Number 6, June 2005).
Click here for summary paper.

Defining Your Product Profile and Maintaining Control Over It: The Challenges of Monitoring Host Cell Protein Impurities
The summary paper has been published in BioProcess International (Volume 3, Number 6, September 2005).
Click here for summary paper.

Defining Your Product Profile and Maintaining Control Over It: Product-Related Impurities
The summary paper has been published in BioProcess International (Volume 3, Number 9, October 2005).
Click here for summary paper.

Defining Your Product Profile and Maintaining Control Over It: Product-Related Impurities-Tackling Aggregates
The summary paper has been published in BioProcess International (Volume 3, Number 10, November 2005).
Click here for summary paper.

January 5, 2004 Washington, DC
Life Cycle Approach to Setting Specifications for Biotechnology-Derived Products
The summary review has been published in The Gold Sheet (Volume 38, Number 9, September 2004).
Click here for summary review.

September 19, 2003 Philadelphia, Pennsylvania
Mycoplasma In-Process and Lot Release Test: To PCR Or Not To PCR
The summary paper has been published in BioProcess International (Volume 3, Number 11, December 2005).
Click here for summary paper.

July 24, 2003 Gaithersburg, Maryland
What Is Test Method Qualification?
The summary paper has been published in BioProcess International (Volume 2, Number 8, September 2004).
Click here for summary paper.

January 6, 2003 San Francisco, California
Analysis and Structure Characterization of Monoclonal Antibodies
The summary paper has been published in BioProcess International (Volume 2, Number 2, February 2004).
Click here for summary paper.

September 19, 2002 Boston, Massachusetts
Strategies to Establish Release Specifications for Peptide Maps
The summary paper has been published in BioPharm International (Volume 16, Number 4, April 2003).
Click here for summary paper.



 

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