Regulatory Affairs
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Bio News | Collaborations & Alliances | Industry News | Regulatory Affairs
Recipharm Receives EMVO Approval
The connection, facilitated by strategic partner TraceLink is to to submit serialization data to the European Hub09.13.18
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Regulatory Affairs
FDA and Field Alert Reports
Analysis of “Field Alert Report Submission Questions and Answers Guidance for Industry”Constance Richard-Math, Lachman Consultants 09.11.18
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Bio News | Collaborations & Alliances | Drug Development | Drug Discovery | Industry News | Regulatory Affairs
CCAB, ImmunoBiochem Partner for Cancer
CCAB to help advance ImmunoBiochem’s novel breast cancer therapeutic candidate one step closer to the clinic08.23.18
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Facilities | Inspections | QA/QC | Regulatory Affairs
Are Indian Generic Firms Improving Compliance?
Indian firms take the generics battle to U.S. turf.Online Exclusives S. Harachand, Contributing Editor 08.09.18
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Drug Development | Regulatory Affairs
Why Otsuka Outsourced Regulatory Affairs
How outsourcing regulatory affairs gave Otsuka flexibility to move products through the development process faster.Online Exclusives Kristin Brooks, Managing Editor 08.09.18
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QA/QC | Regulatory Affairs
Data Integrity Awareness in Pharma
Most data integrity violations are just a result of simple lack of knowledge, negligence, or even a wrong management strategyVideos
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Collaborations & Alliances | Regulatory Affairs | Serialization
Abdi Ibrahim Selects rfxcel for FMD Compliance
Will support serialization software to ensure compliance with current & future international legislative requirements08.02.18
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Information Technology | QA/QC | Regulatory Affairs
Top 5 Misconceptions About Data Integrity
Ron Tetzlaff of PAREXEL Consulting reveals the top five misconceptions management has about data integrityVideos
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Regulatory Affairs
Elemental Impurity & Risk Assessment
An update on the retirement of USP General Chapter <231>.Paul Mason, Lachman Consultants 07.20.18
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Industry News | Promotions & Moves | Regulatory Affairs
Slayback Appoints Global Affairs SVP
Joan Janulis is also a noted speaker at various FDA/Industry conferences07.17.18
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Clinical Trials | Drug Development | Regulatory Affairs
Are EMA-Style Rules for First-in-Human Trials Coming to North America?
Insights from the 2018 DIA Global MeetingBeatrice Setnik, Ph.D., Vice President, Scientific and Clinical Strategy, Early Phase, Syneos Health 07.03.18
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Bio News | GMPs/GCPs | Industry News | Regulatory Affairs
MHRA Grants MeiraGTx Manufacturer’s Authorization
Enables the manufacture of gene therapy product candidates in current cGMP compliant facility06.21.18
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cGMP Manufacture | Industry News | Regulatory Affairs
Samsung BioLogics Licensed by Health Canada
To manufacture a monoclonal antibody drug substance at its first plant06.21.18
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APIs | Breaking News | Collaborations & Alliances | Industry News | Process Validation | Regulatory Affairs
WuXi STA Enables Ascletis to Receive NDA Approval from China FDA for Ganovo
Is first CDMO to support the approval of an innovative drug in China through the MAH pilot program06.14.18
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Regulatory Affairs | Solid Dosage/Creams/Ointments
Semi-Solid Dosage Forms
Compliance of semi-solid dosages to FDA Stage III Continuous Process VerificationJosé L. Toro, Ph.D., Lachman Consultants 06.12.18
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Inspections | Regulatory Affairs
PAI Readiness – A Journey, not an Event
A look at what you need to do to get ready for a pre-approval inspectionDr. Walter Matzmorr, Tunnell Consulting 06.12.18
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QA/QC | Regulatory Affairs
The Outsourcing Balancing Act
Achieving the best blend of oversight and involvementLeona Fitzgerald and Denise Moody, PPD 06.12.18
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Bio News | cGMP Manufacture | Industry News | Regulatory Affairs | Risk Management
Stellar Announces Positive Third-Party Trial Results
The company's KLH manufacturing methods have achieved robust viral clearance05.29.18
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cGMP Manufacture | Industry News | Regulatory Affairs
Recipharm Plans for Brexit
Establishes a dedicated taskforce to manage the potential impact on ops05.24.18
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Drug Development | Industry News | Promotions & Moves | Regulatory Affairs
Corbus Announces Key Hires
Dr. Robert Discordia will serve as VP, Pharmaceutical Development & Mfg, and Ross Lobell will serve as VP, Regulatory Affairs05.22.18
