Regulatory Affairs

Serialization: Background, Justification, Requirements, Timelines, and Readiness Across the Supply Chain
Regulatory Affairs
Serialization: Background, Justification, Requirements, Timelines, and Readiness Across the Supply ChainSerialization: Background, Justification, Requirements, Timelines, and Readiness Across the Supply Chain

byDan Walles
Dec 13, 2017
Therapeutic IgG-Like Bispecific Antibodies: Modular Versatility and Manufacturing Challenges, Part 1
Manufacturing
Therapeutic IgG-Like Bispecific Antibodies: Modular Versatility and Manufacturing Challenges, Part 1Therapeutic IgG-Like Bispecific Antibodies: Modular Versatility and Manufacturing Challenges, Part 1
byJennifer Bratt, Angela Linderholmand 2 more
Dec 13, 2017
Transforming Deviation Management
Risk Management
Transforming Deviation ManagementTransforming Deviation Management
byBrian Chviruk, Ewald Amherdand 3 more
Sep 19, 2017
Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (CMC Forum)
CMC Forums
Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (CMC Forum)Change Happens: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management (CMC Forum)
byJoseph Kutza, PhD, Julia Edwardsand 5 more
Sep 19, 2017
Polysorbates, Biotherapeutics, and Anaphylaxis: A Review
Formulation
Polysorbates, Biotherapeutics, and Anaphylaxis: A ReviewPolysorbates, Biotherapeutics, and Anaphylaxis: A Review
byEdward Maggio
Sep 19, 2017
Regulation, Analytical, and Process Issues with Leachables: Toward Harmonization for Latin America with Europe and North America
Single Use
Regulation, Analytical, and Process Issues with Leachables: Toward Harmonization for Latin America with Europe and North AmericaRegulation, Analytical, and Process Issues with Leachables: Toward Harmonization for Latin America with Europe and North America
byVíctor Pérez Medina Martínez, Victor R. Campos-Garcíaand 4 more
Aug 23, 2017
An Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems
Single Use
An Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems
An Industry Proposal for Change Notification Practices for Single-Use Biomanufacturing Systems
May 18, 2017
+2
byby Eric Isberg, James Vogeland 2 more
Implementing Quality By Design in Analytical Development: A Case Study on the Development of an Anion-Exchange HPLC Method
Regulatory Affairs
Implementing Quality By Design in Analytical Development: A Case Study on the Development of an Anion-Exchange HPLC Method
Implementing Quality By Design in Analytical Development: A Case Study on the Development of an Anion-Exchange HPLC Method
May 18, 2017
+1
byQuan Yuan, Weijun Liand 1 more
The Clinical Side of Biosimilar Development
Biosimilars
The Clinical Side of Biosimilar Development
The Clinical Side of Biosimilar Development
Apr 12, 2017
byBruno Speder
CMC Strategy Forum on Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs, and Regulatory Expectations
CMC Forums
CMC Strategy Forum on Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs, and Regulatory Expectations
CMC Strategy Forum on Combination Products for Biopharmaceuticals: Emerging Trends in Development, GMPs, and Regulatory Expectations
Mar 20, 2017
+6
bySiddharth J. Advant, PhD, Jee Chungand 6 more
Postapproval Changes for Biopharmaceutical Drug-Substance and Drug-Product Manufacture: Regulatory Complexity and Impact
Regulatory Affairs
Postapproval Changes for Biopharmaceutical Drug-Substance and Drug-Product Manufacture: Regulatory Complexity and Impact
Postapproval Changes for Biopharmaceutical Drug-Substance and Drug-Product Manufacture: Regulatory Complexity and Impact
Dec 13, 2016
+5
byCathy Hoath, Lucy Changand 5 more
Special Report on Process- and Product-Related Impurities (A CMC Strategy Forum Special Focus Series): Extractables, Leachables, Particles, and
CMC Forums
Special Report on Process- and Product-Related Impurities (A CMC Strategy Forum Special Focus Series): Extractables, Leachables, Particles, and Aggregates
Special Report on Process- and Product-Related Impurities (A CMC Strategy Forum Special Focus Series): Extractables, Leachables, Particles, and Aggregates
Nov 17, 2016
+3
byAnthony Mire-Sluis, Stacey Maand 3 more
Manufacturing Plasmid DNA: Ensuring Adequate Supplies for Gene and Cell Therapies
Cell Therapies
Manufacturing Plasmid DNA: Ensuring Adequate Supplies for Gene and Cell Therapies
Manufacturing Plasmid DNA: Ensuring Adequate Supplies for Gene and Cell Therapies
Oct 17, 2016
byTony Hitchcock
Biosimilar Therapeutic Monoclonal Antibodies: Gaps in Science Limit Development of an Industry Standard for Their Regulatory Approval, Part 1
Biosimilars
Biosimilar Therapeutic Monoclonal Antibodies: Gaps in Science Limit Development of an Industry Standard for Their Regulatory Approval, Part 1
Biosimilar Therapeutic Monoclonal Antibodies: Gaps in Science Limit Development of an Industry Standard for Their Regulatory Approval, Part 1
Oct 14, 2016
+3
bySimran J. Kaur, Darryl Sampeyand 3 more
Collaboration Is Key to Innovation in Biotechnology logo in a gray background | Collaboration Is Key to Innovation in Biotechnology
Economics
Collaboration Is Key to Innovation in Biotechnology
Collaboration Is Key to Innovation in Biotechnology
Oct 14, 2016
byDonald Johnston
Managing Customer and Regulatory Expectations
Contract Services
Managing Customer and Regulatory Expectations
Managing Customer and Regulatory Expectations
Sep 15, 2016
byFranco Negron
Regulating Quality in Continuous Processing logo in a gray background | Regulating Quality in Continuous Processing
Sponsored Content
Regulating Quality in Continuous Processing
Regulating Quality in Continuous Processing
Jun 27, 2016
byMike Quesenberry, James Hathcock
Quality By Design for Monoclonal Antibodies, Part 1: Establishing the Foundations for Process Development
Process Development
Quality By Design for Monoclonal Antibodies, Part 1: Establishing the Foundations for Process Development
Quality By Design for Monoclonal Antibodies, Part 1: Establishing the Foundations for Process Development
Jun 16, 2016
+1
byBrendan Cooney, Susan Dana Jonesand 1 more
A Turning Point for US Biosimilars logo in a gray background | A Turning Point for US Biosimilars
Regulatory Affairs
A Turning Point for US Biosimilars
A Turning Point for US Biosimilars
May 11, 2016
byCarlos Angulo
Addressing Variability in Product Labeling: Explore Dynamic Labeling for Your Global Enterprise logo in a gray background | Addressing Variability in Product Labeling: Explore Dynamic Labeling for Your Global Enterprise
Regulatory Affairs
Addressing Variability in Product Labeling: Explore Dynamic Labeling for Your Global Enterprise
Addressing Variability in Product Labeling: Explore Dynamic Labeling for Your Global Enterprise
Apr 11, 2016
byMike Ward
The Year of Data Integrity: 2015 Brought a Worldwide Focus on Training, System Design and Control, and Data Management
Information Technology
The Year of Data Integrity: 2015 Brought a Worldwide Focus on Training, System Design and Control, and Data Management
The Year of Data Integrity: 2015 Brought a Worldwide Focus on Training, System Design and Control, and Data Management
Mar 11, 2016
byDoug Chambers
Responding to an FDA Form 483: A Five-Step Approach
MAb
Responding to an FDA Form 483: A Five-Step Approach
Responding to an FDA Form 483: A Five-Step Approach
Feb 4, 2016
byTaylor Burtis
Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations logo in a gray background | Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations
Product Characterization
Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations
Bridging Analytical Methods for Release and Stability Testing: Technical, Quality and Regulatory Considerations
Feb 4, 2016
+9
byNadine Ritter, Reb Russelland 9 more
Disposable Components in Biomanufacturing: A Regulatory Perspective
Single Use
Disposable Components in Biomanufacturing: A Regulatory Perspective
Disposable Components in Biomanufacturing: A Regulatory Perspective
Dec 18, 2015
byPeter Calcott
Bioindustry Researchers Take Strides in Preventing Diseases: Developments in Genetic Diagnosis and Therapy
Economics
Bioindustry Researchers Take Strides in Preventing Diseases: Developments in Genetic Diagnosis and Therapy
Bioindustry Researchers Take Strides in Preventing Diseases: Developments in Genetic Diagnosis and Therapy
Dec 16, 2015
byPeter Huber
Elucidation: Centers for the Innovation in Advanced Development and Manufacturing logo in a gray background | Elucidation: Centers for the Innovation in Advanced Development and Manufacturing
Regulatory Affairs
Elucidation: Centers for the Innovation in Advanced Development and Manufacturing
Elucidation: Centers for the Innovation in Advanced Development and Manufacturing
Dec 16, 2015
+2
byMichael P. Angelastro, R. Thomas Warfand 2 more
Special Report on Assays, Test Methods, and Comparability: The CMC Strategy Forum Series, Part 4, Introduction
CMC Forums
Special Report on Assays, Test Methods, and Comparability: The CMC Strategy Forum Series, Part 4, Introduction
Special Report on Assays, Test Methods, and Comparability: The CMC Strategy Forum Series, Part 4, Introduction
Nov 17, 2015
byCheryl Scott
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining logo in a gray background | Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining
QA/QC
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining Biopharmaceutical Quality
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, The Role of Higher-Order Structure in Defining Biopharmaceutical Quality
Nov 17, 2015
+3
byZiping Wei, Emily Shacterand 3 more
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized logo in a gray background | Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized
QA/QC
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase, and Postapproval
Special Report on Assays, Test Methods, and Comparability The CMC Strategy Forum Series, Part 4, Demonstrating Comparability for Well-Characterized Biotechnology Products: Early Phase, Late Phase, and Postapproval
Nov 17, 2015
byJohn Towns, Keith Webber
Management, Notification, and Documentation of Single-Use Systems Change Orders: Challenges and Opportunities
Single Use
Management, Notification, and Documentation of Single-Use Systems Change Orders: Challenges and Opportunities
Management, Notification, and Documentation of Single-Use Systems Change Orders: Challenges and Opportunities
Oct 15, 2015
byTony White, Kevin Ott
Comprehensive Hands-On Training for Biopharmaceutical Manufacturing: BTEC’s Program to Deliver Training to FDA Investigators
MAb
Comprehensive Hands-On Training for Biopharmaceutical Manufacturing: BTEC’s Program to Deliver Training to FDA Investigators
Comprehensive Hands-On Training for Biopharmaceutical Manufacturing: BTEC’s Program to Deliver Training to FDA Investigators
Sep 23, 2015
byGary Gilleskie, Patty Brown
Challenges in Implementing Quality By Design: An Industry Perspective
Process Development
Challenges in Implementing Quality By Design: An Industry Perspective
Challenges in Implementing Quality By Design: An Industry Perspective
Jun 16, 2015
byMichael Torres
Can English Unite SE Asian Markets? logo in a gray background | Can English Unite SE Asian Markets?
Bioregions
Can English Unite SE Asian Markets?
Can English Unite SE Asian Markets?
May 12, 2015
byKaren Politis Virk
Expanded Change Protocols: Benefits, Cost Considerations, and Regulatory Views
CMC Forums
Expanded Change Protocols: Benefits, Cost Considerations, and Regulatory Views
Expanded Change Protocols: Benefits, Cost Considerations, and Regulatory Views
Mar 10, 2015
+6
byNadine Ritter, Julia Edwardsand 6 more
Cancer Innovation Forum Calls for Improving US Research “Ecosystem”
Pre-Clinical & Clinical Trials
Cancer Innovation Forum Calls for Improving US Research “Ecosystem”
Cancer Innovation Forum Calls for Improving US Research “Ecosystem”
Feb 6, 2015
byNancy Davenport-Ennis

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