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Regulatory Affairs
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Information Technology
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Regulatory Affairs
The Future of Pharmacovigilance is Proactive
Data and AI can unlock the path to proactivity.
Bruce Palsulich, Vice President of Safety, Oracle Life Sciences
05.13.24
Aseptic Processing
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Facilities
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Fill/Finish
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Injectables
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Parenterals
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Regulatory Affairs
Parenteral Perspectives
Exploring innovations, challenges, and future horizons in parenteral drug delivery.
Tim Wright, Editor, Contract Pharma
05.13.24
Information Technology
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Regulatory Affairs
"3 Key Trends" with Rob Feltz
Sharp Services’ Director of Analytical and Formulation Services offers his thought leadership.
Online Exclusives
Contract Pharma
05.01.24
Regulatory Affairs
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Serialization
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Supply Chain
Anti-Counterfeiting Technology
How track and trace, serialization, and secondary packaging are defining the future.
Ben Locwin, Contributing Editor
04.10.24
QA/QC
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Regulatory Affairs
Do You Know Your Product's Impurity Profile?
Regulatory insights from the experts at Lachman Consultants.
Paul Mason, Executive Director, Lachman Consultants
04.10.24
Biosimilars
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Regulatory Affairs
Inflation Reduction Act and the Impact on Biosimilars
Exploring the IRA’s provisions and their impact to biosimilars.
Dinakaran (Dina) Balasubramanian, Dr. Reddy's Laboratories
04.10.24
Analytical Services
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Methods Development
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QA/QC
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Regulatory Affairs
Regulatory Affairs: What is the New FDA Guidance on Q14 Analytical Procedure Development?
Insights from the experts at Lachman Consultants.
Joseph Posada, Consultant, Lachman Consultants
04.05.24
Clinical Trials
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Drug Development
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Regulatory Affairs
The High Five: Key Regulatory Topics for Drug Development in 2024
Master protocols in clinical trial design, patient outcomes in oncology, advancements of new modalities, use of AI/ML and digitizing clinical trials.
Patrick Brady, PharmD, Global Head, Therapeutic Innovation & Regulatory Science, IQVIA
03.18.24
Regulatory Affairs
The “Hows” of Drug Shortages
How bad does the problem need to become for Congress to act?
Martin Shimer, Executive Director, Lachman Consultants
03.15.24
Aseptic Processing
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Facilities
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Fill/Finish
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Information Technology
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Injectables
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Parenterals
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Regulatory Affairs
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Supply Chain
The Road Ahead for CDMOs in 2024
Whether it’s an imminent supply chain reckoning, or a raft of new modalities, excellent opportunities still abound for the “right” CDMOs.
Gil Roth, Pharma & Biopharma Outsourcing Association (PBOA)
03.11.24
Biosimilars
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Regulatory Affairs
Regulatory Affairs: The Generic Industry Faces External Challenges
Insights from the regulatory experts at Lachman Consultants.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
03.04.24
Regulatory Affairs
Regulatory Affairs: The Eyes Have It!
Insights from the regulatory experts at Lachman Consultants.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
02.23.24
Regulatory Affairs
Regulatory Affairs: Canada Responds to Florida’s Import Plan
Canada springs into action after FDA approves Florida’s plan to import drugs from our neighbors in the North.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
02.08.24
Inspections
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QA/QC
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Regulatory Affairs
Regulatory Affairs: FDA’s Office of Compliance Issues FY 2023 Annual Report
Issued 170 warning letters and monitored 264 drug recall events during the year.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
02.01.24
Analytical Services
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Bioanalytical Services
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Laboratory Testing
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QA/QC
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Regulatory Affairs
Stability Testing for Drug Products: Ensuring Safety, Efficacy & Regulatory Compliance
Evaluating extractables and leachables, overseeing manufacturing processes, ensuring adherence to CGMPs and comprehensive packaging testing.
Sandi Schaible and Britt Jones, WuXi AppTec
02.01.24
Biologics, Proteins, Vaccines
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Drug Development
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Regulatory Affairs
2023: The Year of Re-alignment, Yet All Data Points to Green Shoots Ahead for 2024
An in-depth analysis of the health of the CRO/CDMO sector.
Brian Scanlan, Operating Partner - Life Sciences, Edgewater Capital Partners
02.01.24
Inspections
|
Regulatory Affairs
FDA Inspections & Compliance Trends
A look back at 2023 and what 2024 will bring.
Online Exclusives
Ben Locwin , Contributing Writer
01.26.24
Information Technology
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Regulatory Affairs
Regulatory Affairs: Cross-Agency Cooperation Takes Next Step in AI Maturity
A blog exploring the regulatory issues impacting the pharma industry with the experts at Lachman Consultants.
Patrick Day, M.S., Principal Consultant, Lachman Consultants
01.19.24
Regulatory Affairs
Regulatory Affairs: Florida the First State to Receive FDA’s Authorization for Canadian Drug Import Program
How will Canada react if the importing of drugs from the U.S. winds up causing shortages of the imported products in Canada?
01.12.24
Regulatory Affairs: Drug Shortages
EU issues communication addressing medicine/drug shortages.
Patrick Day, M.S., Principal Consultant, Lachman Consultants
11.17.23
Breaking News
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Clinical Trials
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CRO News
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Drug Development
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Regulatory Affairs
Odyssey Health Selects Syneos to Support Concussion Treatment Trial
Will provide a regulatory review for the clinical development plans for Odyssey's concussion drug ONP-002 and novel intranasal device.
11.16.23
Information Technology
|
Regulatory Affairs
FDA Watch: Artificial Intelligence
Cross-agency cooperation takes next step in artificial intelligence maturity.
Patrick Day, M.S., Principal Consultant, Lachman Consultants
11.09.23
QA/QC
|
Regulatory Affairs
How Mature is Your Quality Management Program?
Technology is key in driving quality improvement.
Paul Mason, Ph.D., Senior Director, Lachman Consultants
11.02.23
Drug Development
|
Regulatory Affairs
Challenges and Opportunities of the Health Technology Assessment Regulation
Deciphering EU HTA legislation ahead of the 2025 implementation deadline.
Anke van Engen and Edel Falla, IQVIA
10.23.23
Analytical Services
|
Bioanalytical Services
|
Biologics, Proteins, Vaccines
|
Regulatory Affairs
"3 Key Trends" with Kai Lipinski
ReciBioPharm’s Chief Scientific Officer offers his thought leadership.
Online Exclusives
10.20.23
QA/QC
|
Regulatory Affairs
Quality Management Paradigm Shift: Risk-Centric Practices Come Center Stage
Data-driven, pro-innovation strategies advance new-era therapies.
Soman Harachand, Contributing Writer
10.17.23
Regulatory Affairs
Signs of Progress on the Nitrosamine Front
Notes from the Nitrosamines Session at GRx+Biosims 2023.
Jennifer Leaming, Principal Consultant, Lachman Consultants
10.13.23
Breaking News
|
Industry News
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Regulatory Affairs
Lilly Receives Complete Response Letter for Lebrikizumab
FDA declines to approve eczema therapy after finding issues at a third-party contract manufacturing organization.
10.02.23
Logistics
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Regulatory Affairs
Pharmaceutical Labeling: Overcoming Regulatory & Operational Challenges
Regulatory agencies are adapting to the digital age by implementing processes and documentation enabled by modern technology.
Rama Mohan Rao Chikkam, Senior Director of Global Regulatory Affairs-India, IQVIA
09.13.23
APIs
|
R&D
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Regulatory Affairs
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Solid Dosage/Creams/Ointments
|
Supply Chain
USP'S Continuous Manufacturing Knowledge Center is Live!
...
Breaking News
|
Industry News
|
Regulatory Affairs
|
Supply Chain
LighthouseAI Secures $2.25M Investment to Grow Supply Chain Products
Funding aims to accelerate the development of compliance automation solutions.
08.14.23
Breaking News
|
Drug Development
|
Drug Discovery
|
Industry News
|
Promotions & Moves
|
Regulatory Affairs
|
Trials & Filings
Boyds Launches New Regulatory Operations Service
Will provide planning, coordination, and execution of all tasks relating to the development, and maintenance of regulatory documents.
08.07.23
Breaking News
|
Clinical Trials
|
Drug Development
|
Drug Discovery
|
Promotions & Moves
Akari Therapeutics Names Beth-Anne Lang Senior VP of Regulatory Affairs
Lang brings more than 20 years of experience in regulatory strategy, regulatory affairs, and drug development.
08.02.23
Regulatory Affairs
Annex 1 Sterile Manufacturing Requirements
Are you considering Annex 1 sterile manufacturing requirements?
Keith Lamb & John Darby , Lachman Consultant Services, Inc.
07.19.23
Regulatory Affairs
FDA Regulatory Report
A look at recent Agency initiatives.
Ben Locwin, Contributing Writer
06.13.23
Drug Development
|
Drug Discovery
|
Laboratory Testing
|
QA/QC
|
R&D
|
Regulatory Affairs
CRO Regulatory Landscape
Navigating the changing regulatory landscape for laboratory-developed tests: A CRO lab perspective.
Poluru Reddy and Anup Madan, PPD
06.13.23
Clinical Trial Materials
|
Clinical Trials
|
Drug Development
|
Regulatory Affairs
Regulatory Affairs: Accelerating Drug Development Timelines
How Canada’s 30-day regulatory review process could provide an advantage.
Roland Jbeily, Manager of Regulatory Affairs, Altasciences
06.01.23
Inspections
|
QA/QC
|
Regulatory Affairs
FDA 2023 Inspection Roadmap: Is “Readiness” in Your Annual Objectives?
Insights from the regulatory experts at Lachman Consultants.
Patrick Day, M.S., Principal Consultant, Lachman Consultants
05.25.23
QA/QC
|
Regulatory Affairs
FDA Watch: Are You Suitably Staffed?
Insights from the regulatory experts at Lachman Consultants.
Paul Mason, Ph.D., Senior Director, Lachman Consultants
05.18.23
Regulatory Affairs
|
Supply Chain
FDA Watch: Is Your Supply Chain at Risk?
Insights from the regulatory experts at Lachman Consultants.
Patrick Day, M.S., Principal Consultant, Lachman Consultants
05.12.23
Breaking News
|
Promotions & Moves
Scorpius BioManufacturing Names Joe Payne Quality & Regulatory Affairs VP
Payne brings more than 20 years of experience working at CDMOs and large pharma companies.
05.11.23
Regulatory Affairs
FDA Watch: CDER to Launch Guidance Snapshot Pilot Program
Insights from the regulatory experts at Lachman Consultants.
Bob Pollock, Senior Advisor, Outside Director to the Board, Lachman Consultant Services, Inc.
05.05.23
Fill/Finish
|
Parenterals
|
Regulatory Affairs
|
Supply Chain
"3 Key Trends" with Paul Josephs
Woodstock Sterile Solutions’ President and CEO offers his thought leadership.
Online Exclusives
Contract Pharma
05.05.23
Information Technology
|
Regulatory Affairs
Data Management and Compliance
Your knowledge is only as good as your data, and probably less so.
Ben Locwin, Contributing Editor
05.03.23
GMPs/GCPs
|
Inspections
|
QA/QC
|
Regulatory Affairs
Pharmaceutical Recall Trends to Watch in 2023
2022 was a record-breaking year for the number of units recalled, up 114% over 2021.
Online Exclusives
Kristin Brooks, Managing Editor, Contract Pharma
03.31.23
Biologics, Proteins, Vaccines
|
Regulatory Affairs
What Does the Future of Gene Therapy Hold?
The future of gene therapy has never looked more promising.
Online Exclusives
Emily Newton, Contributing Writer
03.10.23
Drug Development
|
Information Technology
|
Regulatory Affairs
Automated Regulatory Electronic Publishing: How is It Changing the Industry?
The digital approach allows companies to organize and take a more data-driven strategy when compiling submissions.
Jason Berning, Associate Director Business Development for Quality Compliance Solutions at IQVIA
03.07.23
Drug Development
|
Regulatory Affairs
Regulatory Strategies for Optimized Product Lifecycle Management
Approaches to overcome obstacles of planning and managing regulatory activities throughout a pharmaceutical product’s lifecycle.
Michael Kardas, VP, Regulatory Affairs and Drug Development Solutions, IQVIA
03.03.23
Biologics, Proteins, Vaccines
|
Breaking News
|
Clinical Trials
|
Drug Development
|
Regulatory Affairs
|
Trials & Filings
WestVac Biopharma Acquires Accreditation as Foreign Drug Manufacturer in Japan
The accreditation is a significant step toward the commercialization of its COVID-19 vaccine in Japan.
03.02.23
Clinical Trials
|
Regulatory Affairs
Don’t Panic! A Toxicologist’s View on Proceeding After a Clinical Hold
Step back, reassess your program, and move forward with a solid strategy in place.
Tim Wright, Editor, Contract Pharma
02.06.23
Breaking News
Johnson & Johnson Agrees to Acquire Proteologix
Veranova, Phorum.AI Partner on Generative AI Chemistry Optimization
Galapagos, Blood Centers of America Enter Strategic CAR-T Mfg. Pact
First Wave BioPharma Rebrands to Entero Therapeutics
BMS’s CAR T Cell Therapy Breyanzi Approved for Follicular Lymphoma
View Breaking News >
CURRENT ISSUE
May 2024
CDMOs: The Cornerstone of Biopharmaceutical Innovation
Pharma 4.0: CDMOs Digitalize to Enhance Customer Value
CEO Spotlight: Gaston Salinas
Parenteral Perspectives
The Transformative Potential of Gene Therapy
Creating Solutions for CDMOs: An EPCMV Firm’s Perspective
Single-use Fermenters for Microbial Biopharma Development & Manufacturing
View More >