Regulatory Affairs
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Breaking News | Facilities | Industry News | Regulatory Affairs
Sterling Pharma Solutions Recognized for Achievements in Sustainability
Awarded Gold Medal by EcoVadis.09.03.21
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Bio News | Biologics, Proteins, Vaccines | Breaking News | Collaborations & Alliances | Industry News | Regulatory Affairs
FDA Approves Pfizer-BioNTech COVID-19 Vaccine COMIRNATY
Grants first full approval for COVID vaccine.08.23.21
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Breaking News | Industry News | QA/QC | Regulatory Affairs | Supply Chain
United States Pharmacopeia Acquires Pharmatech Associates
Expanded offerings will help regulated life science companies strengthen the supply chain for safe, quality medicines.07.09.21
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Information Technology | QA/QC | Regulatory Affairs
The Importance of Data Integrity Risk Assessment
Executing Data Integrity Risk Assessments for systems that generate and store both paper (manual)-based systems as well as computer-based and hybrid systems.Paul Mason, Ph.D., Lachman Consultants 06.07.21
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Regulatory Affairs
Meeting with the FDA: Valuing the Statistician and Preparation for Review
A look at the key roles and responsibilities of FDA and biopharmaceutical industry statisticians throughout product lifespan.Joshua Baker, VP and LaRee Tracy, PHASTAR 05.27.21
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Clinical Trials | R&D | Regulatory Affairs
Unifying Quality Manufacturing to Drive Speed, Collaboration, and Compliance
Learn how you can unify end-to-end quality management to improve visibility, efficiency, and compliance in this webinar on May 13.04.22.21
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Biologics, Proteins, Vaccines | Regulatory Affairs
What Will Change at FDA for 2021?
(R)evolution of the industry’s data, catalyzed by changes at FDA and what’s the likely impact to the pharmaceutical industry?Ben Locwin, Contributing Editor, International COVID-19 Advisor, Healthcare Futurist 04.01.21
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Regulatory Affairs
Post-Pandemic Regulations
Envisioning clinical development regulatory practices in a post-pandemic world.Ronan Brown, SVP and Head of Integrated Global Compliance, IQVIA 04.01.21
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Biologics, Proteins, Vaccines | Regulatory Affairs
The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to “normalcy.”Chad Landmon, Michelle Divelbiss and Alex Alfano, Attorneys - Axinn, Veltrop & Harkrider LLP 01.27.21
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Breaking News | Drug Development | Industry News | Information Technology | Regulatory Affairs
Top BioPharma Form Accumulus Synergy
Aims to develop a cloud-based Global Data Sharing Platform to facilitate data and information sharing between industry and health authorities worldwide.Kristin Brooks 01.22.21
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Drug Development | Industry News | Regulatory Affairs
The Year of COVID: How FDA Coped with a Worldwide Pandemic in 2020 and What to Expect in 2021
A look at EUA standards and approvals, unavoidable pitfalls, Operation Warp Speed, FDA’s use of Real-World Evidence, and a slow return to "normalcy".Chad Landmon, Michelle Divelbiss and Alex Alfano, Axinn, Veltrop & Harkrider LLP's Intellectual Property and Food and Drug Administration Practice Groups 01.05.21
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APIs | Clinical Trial Materials | Process Validation | QA/QC | Regulatory Affairs
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QA/QC | Regulatory Affairs
Regulatory Compliance Trends
Re-assessing outsourcing strategies for ‘new normal’ regulatory compliance.Steve Cottrell, President, Maetrics 10.14.20
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Biologics, Proteins, Vaccines | Regulatory Affairs
Ensuring Manufacturing Continuity for Essential Medicines
Applying the principles of Quality Risk Management to get medicines to market faster.John Darby, M.Sc., Senior Director, Lachman Consultant Services, Inc. 09.09.20
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Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
Expediting a COVID-19 Vaccine: FDA Approval Process
The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.Kristin Brooks, Managing Editor 09.09.20
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Aseptic Processing | Bio News | Biologics, Proteins, Vaccines | Breaking News | Facilities | Industry News | Regulatory Affairs
LSNE Expands Aseptic Fill Finish Capabilities in Europe
LSNE-León receives approval from AEMPS to manufacture biotechnology-based therapeutic products.Contract Pharma Staff 08.28.20
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Biologics, Proteins, Vaccines | Drug Development | Regulatory Affairs
Expediting a COVID-19 Vaccine: FDA Approval Process
The pressures of the pandemic are pushing sponsors and FDA to look at both efficacy and speed in developing a vaccine.Online Exclusives Kristin Brooks, Contract Pharma 08.25.20
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Drug Delivery | Regulatory Affairs
Regulatory Overhaul for Medical Devices
Implications for the pharmaceutical industry.Elizma Parry, Director, Global Clinical Practice, Maetrics 06.04.20
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Information Technology | Regulatory Affairs
Data Integrity: Beyond Electronic Records
Get your Data Integrity house in orderTim Rhines, Ph.D., Director, Lachman Consultant Services, Inc. 05.05.20
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Industry News | Regulatory Affairs
FDA COVID-19 Update
Issues guidance highlighting flexibility under the Drug Supply Chain Security ActContract Pharma Staff 05.01.20
