Regulatory Affairs

Implementation of Established Conditions: Learnings from a “Sharing Science Solutions” Workshop
CMC Forums
Implementation of Established Conditions: Learnings from a “Sharing Science Solutions” WorkshopImplementation of Established Conditions: Learnings from a “Sharing Science Solutions” Workshop

+4
bySarah Kennett, Kristopher Barnthouseand 4 more
Oct 28, 2021
Preparing for a Virtual Audit
Regulatory Affairs
Preparing for a Virtual AuditPreparing for a Virtual Audit
byKate Coleman
Sep 30, 2021
Untapped Potential of Tissue Engineering: The Three Obstacles Holding It Back
Manufacturing
Untapped Potential of Tissue Engineering: The Three Obstacles Holding It BackUntapped Potential of Tissue Engineering: The Three Obstacles Holding It Back
byLev Gerlovin, Andrew Thomsonand 1 more
Apr 26, 2021
Manufacture and Regulation of Cell, Gene, and Tissue Therapies: Part 2 — Regulatory Guidances
Regulatory Affairs
Manufacture and Regulation of Cell, Gene, and Tissue Therapies: Part 2 — Regulatory GuidancesManufacture and Regulation of Cell, Gene, and Tissue Therapies: Part 2 — Regulatory Guidances
byAnjali Apte, Adeyemi Afuwapeand 2 more
Apr 26, 2021
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management
CMC Forums
Emerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle ManagementEmerging Strategies for Drug-Product Comparability and Process Validation: Part 2 — Validation, Legacy Products, and Lifecycle Management
byZahra Shahrokh, Andrew Weiskopfand 7 more
Apr 16, 2021
The EU MDR Deadline Delay: What Does It Entail for Pharmaceutical Companies?
Regulatory Affairs
The EU MDR Deadline Delay: What Does It Entail for Pharmaceutical Companies?The EU MDR Deadline Delay: What Does It Entail for Pharmaceutical Companies?
byBeth Crandall
Mar 9, 2021
COVID-19 As a Catalyst for Changing Orphan-Drug Regulations logo in a gray background | COVID-19 As a Catalyst for Changing Orphan-Drug Regulations
Regulatory Affairs
COVID-19 As a Catalyst for Changing Orphan-Drug Regulations
COVID-19 As a Catalyst for Changing Orphan-Drug Regulations
Mar 9, 2021
byClaudia Wild
The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements
Regulatory Affairs
The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements
The Power of Industry Collaboration: Driving Harmonization of Regulatory Requirements
Feb 4, 2021
byIsabelle Lequeux
Fetal Bovine Serum Source Countries: Comparing Regulatory Animal Health Infrastructures
Regulatory Affairs
Fetal Bovine Serum Source Countries: Comparing Regulatory Animal Health Infrastructures
Fetal Bovine Serum Source Countries: Comparing Regulatory Animal Health Infrastructures
Feb 4, 2021
+1
byOle Bødtker Nielsen, Marc Wintgensand 1 more
Accelerated Pathways for Authorization of Medicines in Europe and the United States
Regulatory Affairs
Accelerated Pathways for Authorization of Medicines in Europe and the United States
Accelerated Pathways for Authorization of Medicines in Europe and the United States
Dec 17, 2020
byShada Warreth
Virtual Audits: A New Reality in the World of COVID-19
Regulatory Affairs
Virtual Audits: A New Reality in the World of COVID-19
Virtual Audits: A New Reality in the World of COVID-19
Jun 10, 2020
byLotte McNamara, Tony Huynh
Cell and Gene Therapies Get a Reality Check: A Conversation with Anthony Davies of Dark Horse Consulting Group
Cell Therapies
Cell and Gene Therapies Get a Reality Check: A Conversation with Anthony Davies of Dark Horse Consulting Group
Cell and Gene Therapies Get a Reality Check: A Conversation with Anthony Davies of Dark Horse Consulting Group
May 24, 2020
+1
byCheryl Scott, Dan Stantonand 1 more
Brazilian JBS Federally Inspected Fetal Bovine Serum
Sponsored Content
Brazilian JBS Federally Inspected Fetal Bovine Serum
Brazilian JBS Federally Inspected Fetal Bovine Serum
Apr 13, 2020
byPaulo A. Reimann
Using Blockchain Technology to Ensure Data Integrity: Applying Hyperledger Fabric to Biomanufacturing
Information Technology
Using Blockchain Technology to Ensure Data Integrity: Applying Hyperledger Fabric to Biomanufacturing
Using Blockchain Technology to Ensure Data Integrity: Applying Hyperledger Fabric to Biomanufacturing
Mar 3, 2020
byJoachim Warschat, René Bergemann
Evaluating Biosimilars: A View from the Small-Molecule World
Biosimilars
Evaluating Biosimilars: A View from the Small-Molecule World
Evaluating Biosimilars: A View from the Small-Molecule World
Feb 7, 2020
byEmil W. Ciurczak
Bioassay Evolution: Finding Best Practices for Biopharmaceutical Quality Systems
QA/QC
Bioassay Evolution: Finding Best Practices for Biopharmaceutical Quality Systems
Bioassay Evolution: Finding Best Practices for Biopharmaceutical Quality Systems
Feb 7, 2020
+2
byCheryl Scott, Laureen Littleand 2 more
Cell Banking for Cell and Gene Therapy: Regulatory, Ethical, and Scientific Considerations
Cell Therapies
Cell Banking for Cell and Gene Therapy: Regulatory, Ethical, and Scientific Considerations
Cell Banking for Cell and Gene Therapy: Regulatory, Ethical, and Scientific Considerations
Jan 31, 2020
+2
byLaertis Ikonomou, Aaron D. Levineand 2 more
eBook: Biologics Stability — Lifecycle Management of Drug Products
Formulation
eBook: Biologics Stability — Lifecycle Management of Drug Products
eBook: Biologics Stability — Lifecycle Management of Drug Products
Dec 17, 2019
byMaribel Rios
eBook: Speed to IND — Balancing Risk and Reward
Economics
eBook: Speed to IND — Balancing Risk and Reward
eBook: Speed to IND — Balancing Risk and Reward
Dec 11, 2019
byS. Anne Montgomery, Susan Dana Jones
Addressing Regulatory Requirements for Filter Integrity Testing
Sponsored Content
Addressing Regulatory Requirements for Filter Integrity Testing
Addressing Regulatory Requirements for Filter Integrity Testing
Oct 28, 2019
byMagnus Stering
Good Manufacturing Practice in China: Equipment Strategy and Quality Management to Compete with the West
Regulatory Affairs
Good Manufacturing Practice in China: Equipment Strategy and Quality Management to Compete with the West
Good Manufacturing Practice in China: Equipment Strategy and Quality Management to Compete with the West
Jun 12, 2019
byVicky Qing Xia
Biologic Labels and Induced Patent Infringement: A Perspective on Evolving US Law
Intellectual Property
Biologic Labels and Induced Patent Infringement: A Perspective on Evolving US Law
Biologic Labels and Induced Patent Infringement: A Perspective on Evolving US Law
May 17, 2019
+1
byStacie L. Ropka, Drew A. Hillierand 1 more
Risk Management of Biopharmaceutical Operations: End-to-End and Over Lifecycle
Sponsored Content
Risk Management of Biopharmaceutical Operations: End-to-End and Over Lifecycle
Risk Management of Biopharmaceutical Operations: End-to-End and Over Lifecycle
May 15, 2019
+3
byJose Menezes, Madalena R. Testasand 3 more
A Harmonized Approach to Data Integrity
Information Technology
A Harmonized Approach to Data Integrity
A Harmonized Approach to Data Integrity
Apr 23, 2019
byKimberley Buytaert-Hoefen
Biosimilars: Challenging the Justifications for Clinical Testing
Biosimilars
Biosimilars: Challenging the Justifications for Clinical Testing
Biosimilars: Challenging the Justifications for Clinical Testing
Jan 31, 2019
bySarfaraz Niazi
Trends in Real-World Study Design and Postmarketing Commitments in the EU and US: What We Can Learn from Big Data
Sponsored Content
Trends in Real-World Study Design and Postmarketing Commitments in the EU and US: What We Can Learn from Big Data
Trends in Real-World Study Design and Postmarketing Commitments in the EU and US: What We Can Learn from Big Data
Jan 30, 2019
byAlexandre Malouvier, Aaron Moss
Biopharmaceutical Characterization, <br>Part 1: Biological Assays &mdash; <br>A Conference Report
Assays
Biopharmaceutical Characterization, Part 1: Biological Assays — A Conference Report
Biopharmaceutical Characterization, Part 1: Biological Assays — A Conference Report
Dec 18, 2018
byCheryl Scott
Viral Risk Mitigation: A Global Regulatory Perspective
Sponsored Content
Viral Risk Mitigation: A Global Regulatory Perspective
Viral Risk Mitigation: A Global Regulatory Perspective
Oct 30, 2018
byMartin Wisher
Seamless Transition from R&D to Manufacturing
Sponsored Content
Seamless Transition from R&D to Manufacturing
Seamless Transition from R&D to Manufacturing
Sep 14, 2018
+9
byGene W. Lee, Kristi Sarnoand 9 more
Innovators and Biosimilar Companies: Experts Predict Intense Conflicts Ahead logo in a gray background | Innovators and Biosimilar Companies: Experts Predict Intense Conflicts Ahead
Regulatory Affairs
Innovators and Biosimilar Companies: Experts Predict Intense Conflicts Ahead
Innovators and Biosimilar Companies: Experts Predict Intense Conflicts Ahead
Jun 20, 2018
byAlison Center
Sourcing Clinical-Grade Human Tissue: Considerations for Supporting Cell Therapy Development and Production
Cell Therapies
Sourcing Clinical-Grade Human Tissue: Considerations for Supporting Cell Therapy Development and Production
Sourcing Clinical-Grade Human Tissue: Considerations for Supporting Cell Therapy Development and Production
Mar 27, 2018
+6
byWayne Vaz, Afshin Shirazianand 6 more
Back to Basics for Biotech: Driving a Culture of Quality and Compliance with Practical Communication Techniques
Regulatory Affairs
Back to Basics for Biotech: Driving a Culture of Quality and Compliance with Practical Communication Techniques
Back to Basics for Biotech: Driving a Culture of Quality and Compliance with Practical Communication Techniques
Mar 23, 2018
byGene Nichols, Laura Osifchin
Beyond Compliance: Serialization Has More to Offer
Fill/Finish
Beyond Compliance: Serialization Has More to Offer
Beyond Compliance: Serialization Has More to Offer
Feb 14, 2018
bySteve Wood
Postapproval CMC Changes: Increasingly a Fact of Biopharmaceutical Life
Regulatory Affairs
Postapproval CMC Changes: Increasingly a Fact of Biopharmaceutical Life
Postapproval CMC Changes: Increasingly a Fact of Biopharmaceutical Life
Jan 29, 2018
byAngelo DePalma
eBook: Challenges Facing Biosimilar Entries into US Markets
Biosimilars
eBook: Challenges Facing Biosimilar Entries into US Markets
eBook: Challenges Facing Biosimilar Entries into US Markets
Jan 16, 2018
bySarfaraz Niazi

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Register Now: Big Impact from Small Samples: Harnessing High-Precision Tunable Laser Spectroscopy for Complex Bioprocessing Analysis
Register Now: Big Impact from Small Samples: Harnessing High-Precision Tunable Laser Spectroscopy for Complex Bioprocessing Analysis
Ask the Expert webcasts
ATE Webcasts
Register Now: Advancing mRNA and CircRNA-based Vaccines and Therapeutics in CMC: From Process Development to Analytics
Register Now: Advancing mRNA and CircRNA-based Vaccines and Therapeutics in CMC: From Process Development to Analytics
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Jun 5 - Jun 6, 2024
Exploit Advances in Exosomes to Improve Efficiencies in Drug Delivery: Connect with senior-level executives and scientists who will share new data and novel case studies on advancing EV products through clinical stage towards commercialization
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Nagase Trehalose SG
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Bruker Tornado Spectroscopy
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Monitoring and Controlling Upstream Bioprocesses with Raman Spectroscopy
Monitoring and Controlling Upstream Bioprocesses with Raman Spectroscopy

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Thermo Fisher White Paper
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Peptones: A Powerful Tool for Manufacturing Complex Protein Therapies
Peptones: A Powerful Tool for Manufacturing Complex Protein Therapies

Nov 21, 2024

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