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All
Drug Discovery and Development
Contract Manufacturing
Packaging
Compliance
Analytical Services
|
Methods Development
|
QA/QC
|
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
|
Drug Development
|
Information Technology
The Future of Pharmacovigilance is Proactive
Data and AI can unlock the path to proactivity.
Bruce Palsulich, Vice President of Safety, Oracle Life Sciences
04.03.24
Biologics, Proteins, Vaccines
|
Clinical Trials
|
Drug Development
Emerging Trends: The State of Pharmacovigilance Outsourcing in Clinical Development
Addressing barriers and evaluating factors in today's drug development landscape and embracing the future of PV innovation.
Gurpreet Singh, Vice President, Managing Director Integrated Safety EMEA at IQVIA
04.01.24
Clinical Trials
|
Drug Development
|
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
Drug Development
|
Drug Discovery
|
Information Technology
Generative AI: Preparing for the Quantum Revolution in Life Sciences
Businesses should focus efforts on simplifying the research process, automating clinical trial protocol, and expediting launch processes.
Bryan Hill, Chief Technology Officer, Life Sciences, Cognizant
03.07.24
Biosimilars
|
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
Biologics, Proteins, Vaccines
|
cGMP Manufacture
Overcoming the Challenges of Automation
Navigating compliance and technological integration in biopharma dark factories.
David Shenberger, Vice President of Strategic Development, CAI
02.29.24
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
|
QA/QC
|
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
Clinical Trials
|
Drug Development
|
Information Technology
Improving R&D Efforts: Clinical Trial Advancements to Watch in 2024
Tech-enabled solutions, decentralized approaches, and enhancing vaccine access.
Chuck Drucker, Greg Lever and Kevin O’Brien, IQVIA
01.29.24
Information Technology
|
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
Clinical Trials
|
Information Technology
Embracing eConsent: Enhancing Clinical Trials
Enhancing patient understanding, improving data transparency and decreasing monitoring time and cost.
Vinita Navadgi, Sr. Director, Product & Strategy, Patient Consent, IQVIA Technologies
01.17.24
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
Clinical Trials
|
Drug Development
Tackling Clinical Trial Staff Burnout Through Technological Advances
A look at what fuels staff burnout in clinical trials, the effects of this fatigue, and creating a new and healthier environment.
Aruna Thapa, Senior Director of Product Strategy, IQVIA
12.18.23
Clinical Trials
|
Drug Development
|
Information Technology
Digital and Decentralized Solutions: Challenges Faced During eDiary Build
How to address challenges of protocol interpretation and planning and eDiary design.
Joe Fahy, Giota Pelekanaki, and Jill Sommerville, PPD clinical research business of Thermo Fisher Scientific
11.29.23
Regulatory Affairs: Drug Shortages
EU issues communication addressing medicine/drug shortages.
Patrick Day, M.S., Principal Consultant, Lachman Consultants
11.17.23
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
Breaking News
BMS 1Q: Opdivo Sales Down 10%, Announces Restructuring Initiative
Pfizer’s BEQVEZ Approved by FDA for Treatment of Adults with Hemophilia B
Abzena Introduces Enhanced Bioassay Platform
Fujifilm & Predictive Oncology Tackle Protein Interference
Regeneron & Mammoth Partner on CRISPR Therapies
View Breaking News >
CURRENT ISSUE
April 2024
Anti-Counterfeiting Technology
Navigating Global CDMO Trends
Weight-loss Drug Packaging
Clinical Supply CDMOs
Industry Experts Weigh in on Oral Solid Dosage
Newsmakers Q&A: Almac Group
Economical Mobile Workstations for Lower-Grade Cleanrooms
Pharmaceutical Manufacturing Equipment & Trends
Insight Into Obesity-Related Clinical Research
Inflation Reduction Act and the Impact on Biosimilars
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