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Regulatory Affairs
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Serialization
The DSCSA Delay What Does it Mean for the Pharma Industry?
What should companies be doing to implement a suitable serialization solution before the new enforcement date arrives?
Erik Haeffler, Recipharm
09.06.17
Information Technology
|
Regulatory Affairs
Data Integrity: A Practical and Risk-Based Approach
Ways an organization can form a culture and cost-effective means to meet the various challenges in sustaining data integrity.
Robert Marohn, ClinLogic, LLC
09.06.17
Regulatory Affairs
|
Serialization
The Psychology of DSCSA: Four Stages of Serialization
It’s time for manufacturers to adopt post-serialization efficiencies.
Larry Hotz, Marketing Manager, WDPrx - Woodfield Pharmaceutical LLC
09.06.17
Cold Chain Management
Cold Chain Market and Technology Trends
Advanced technologies for cold chain management to ensure drug safety and efficacy continue to grow in importance.
Mark Sawicki, Cryoport
09.06.17
Breaking News
|
Drug Development
|
Facilities
|
Formulation Development
|
Industry News
Colorcon Opens New Technology Services Laboratory in Vietnam
Marks the sixth such facility for Colorcon within Southeast Asia
09.05.17
Drug Discovery
How Can We Predict Immunogenicity Earlier in Drug Discovery?
Identifying potential immune responses earlier in the development of biotherapeutics.
Kevin Merlo and Tim Moran, Dassault Systèmes Biovia
09.01.17
Clinical Trials
|
Drug Development
|
Information Technology
Evolution of the CRO Project Manager
As clinical project managers become more strategic, more advanced technology must support their evolving roles
Andy Mehrotra, CEO, EightSpokes
08.31.17
Collaborations & Alliances
|
Drug Development
|
Process Development
MilliporeSigma, Angiex Enter Clinical Readiness Pact
MilliporeSigma to provide access to process development tools, education programs and training
08.29.17
Biologics, Proteins, Vaccines
|
Collaborations & Alliances
|
Drug Development
MilliporeSigma Forms Strategic Vax Development Alliance
Aims to advance vaccine research and development for neglected and emerging infections
08.08.17
Drug Development
|
Industry News
NSF International Adds Pharma Biotech Services in India
To offer pharma biotech consulting and training services from its Gurugram, India office
08.08.17
Drug Development
|
Industry News
Alcami, UNCW Partner on Courses for Pharmaceutical Sciences
Aims to provide students with an overview of the drug development process from concept to commercialization
07.28.17
Clinical Trials
|
Drug Development
CRO Competition Heats Up: Differentiate Offerings to Retain Site Loyalty
Site centricity becomes even more critical with increased CRO competition and M&A
Dave Espenshade, Vice President of CRO Partnerships, Greenphire
07.25.17
Drug Development
|
QA/QC
|
Regulatory Affairs
India Frames Guidance for Drug Surveillance
Outsourcing PV functions to rise
S. Harachand, Contributing Editor
07.18.17
Regulatory Affairs
Data Integrity Guidance Around the World
A look at data integrity controls and the overall framework for a data governance system.
James Davidson, Ph.D, Lachman Consultants
07.18.17
Promotions & Moves
Q Laboratories Appoints New Managers
Bird, Smithmeyer, Hubble to head microbiology R&D lab
06.15.17
Industry News
|
Serialization
Adents Implements Multi-Site, Multi-line Serialization Solution
Installs serialization solution on packaging lines at four sites in France
06.08.17
Bio News
|
Biologics, Proteins, Vaccines
|
cGMP Manufacture
|
Industry News
NIBRT, GE Healthcare Open SU Bio-Mfg. CoE
Aims to drive next-generation biomanufacturing expertise with a new training center
06.08.17
Biologics, Proteins, Vaccines
Trends in New Technologies & Budgets
Budget increases in biopharmaceutical industry indicate future growth
Eric S. Langer, BioPlan Associates
06.06.17
Regulatory Affairs
|
Serialization
Lessons Learned From Global Serialization
A look at some key findings leading up to Europe’s 2019 FMD
Carlos Machado, Serialization Director, SEA Vision U.S.
06.06.17
Drug Development
Solving the Pharma Talent Crunch
Addressing talent shortages in today's pharmaceutical sector
Jim Sykes, Managing Director, Pharmaceutical & Life Sciences, Alexander Mann Solutions
05.30.17
Transforming Sharp into a LEAN organization
Becoming a LEAN organisation is now at the forefront of every CMO’s agenda.
Clinical Trials
|
Drug Development
|
Information Technology
|
Regulatory Affairs
Using Pragmatic Randomization in Real-World Studies
How PCTs increase the robustness of real world studies at a fraction of the cost of classic randomized trials
Nancy Dreyer, MPH, Ph.D. , Global Chief of Scientific Affairs and Senior Vice President, Real-World & Late Phase Research, QuintilesIMS
05.22.17
Sharp Packaging US Surpasses 50 Quality Certifications
Greg Ness, Quality Director for Sharp Packaging Solutions
Clinical Trials
|
Drug Development
|
Information Technology
Breaking New Ground: How Industry Collaboration is Transforming Clinical Research
An increasingly complex clinical trial landscape drives the life sciences industry to support broad collaborations
Jill Johnston, Vice President, Veeva Vault, Veeva Systems
05.15.17
Supply Chain
Strengthen Your Supply Chain
S&OP is critical to optimal decision making in today’s changing pharmaceutical industry
David Medina, Vice President - Solutions and Vertical Markets, QAD, Inc.
05.09.17
Clinical Trials
Tracking Health
Exploring the impact of wearable health monitoring tools on CROs
Nigel Walker
05.09.17
Analytical Services
|
Bioanalytical Services
|
R&D
CROs & Next-Gen Drug Development
R&D trends drive outsourcing in today’s market
Kristin Brooks, Contract Pharma
05.09.17
Bio News
|
cGMP Manufacture
|
Clinical Trial Materials
|
Industry News
|
Scale-up/Technology Transfer
United BioPharma Selects GE’s FlexFactory
To build late-stage clinical and commercial production capacity for biopharmaceuticals
04.25.17
Bio News
|
Biologics, Proteins, Vaccines
|
Drug Development
|
Industry News
|
Laboratory Testing
MilliporeSigma, LabCentral to Foster Biotech Startups
MilliporeSigma to provide access to process development tools, education programs and training
04.25.17
Biologics, Proteins, Vaccines
Biomanufacturing Trends and Outlook 2017: Where Is It All Going?
A look at the technological advances permeating (bio)pharma manufacturing
Ben Locwin, Contributing Editor
04.20.17
Drug Delivery
Inventing the MDI: A History in Modern Inhalation Therapy
3M’s Charlie Thiel offers insight into the pressurized metered-dose inhaler
Online Exclusives
Lynn Melling, Contributing Author
04.19.17
Biosimilars
Biosimilars Update
Fulfilling a dire need, but at what (human) cost?
Ben Locwin, Contributing Editor
04.03.17
Elemental Impurities: A Virtual Company Perspective
A look at risk assessments for elemental impurity determinations in oral tablet and parenteral drug products.
Anthony DeStefano and Thomas Kester, Recordati Rare Diseases, Inc.
04.03.17
Industry News
|
Information Technology
Enterprise System Partners & Werum IT Renew PAS-X Pact
Aims to ensure ESP employees are certified in the delivery of Werum’s PAS-X MES to customers in Europe and USA
03.15.17
Bio News
|
Breaking News
|
Industry News
Cook Pharmica Teams Up With Ivy Tech Bloomington
Partnership to further rural biotechnology education
03.08.17
Regulatory Affairs
Protecting Pharma Intellectual Property
SmartFile CEO offers ways to protect against theft
John Hurley, SmartFile
03.07.17
Biologics, Proteins, Vaccines
CMOs Hiring Constraints: Cell Therapy Manufacturing Expecting Future Challenges
Technically trained staff needed to run complex manufacturing platforms, automation
Eric S. Langer, BioPlan Associates
03.07.17
Regulatory Affairs
|
Serialization
Successful Serialization Partner Selection
Can speed, business value and total cost of ownership exist in the same space when compliance cannot wait?
Michael Howe, CEO, Verify Brand
03.07.17
Regulatory Affairs
|
Serialization
DSCSA Serialization: It’s Not Too Late
If you’re not yet compliant with DSCSA, here are some practical steps to follow
John Jordon and Vito Pirrera, Vantage Consulting Group
03.07.17
Clinical Trials
|
Industry News
|
Information Technology
SGS Launches Simulo Clinical Trial Platform
Designed to facilitate complex clinical trial simulation to predict expected results
02.24.17
Breaking News
|
Collaborations & Alliances
|
Industry News
Sartorius Partners With EMBL
Sartorius is now a member of the group of corporate EMBL partners aiming at connecting industry to academia
02.21.17
Promotions & Moves
Genmab Appoints CDO
Klimovsky to lead Genmab’s product development strategy
02.08.17
Analytical Services
|
Breaking News
|
Collaborations & Alliances
|
CRO News
|
Drug Discovery
|
Industry News
AMRI in Drug Discovery Alliance
Advances mass spectrometry capabilities
02.07.17
Aseptic Processing
|
cGMP Manufacture
Trans-Pacific Aseptic Institute of Training
...
11.09.16
Clinical Trials
|
Process Development
MilliporeSigma to Provide Development and Manufacturing Services to Y-mAbs
Includes scale-up and GMP manufacturing of drugs in late-stage development
08.01.16
Promotions & Moves
|
Regulatory Affairs
Novella Clinical Adds Three Senior-level Hires
Markwood, Bala, Yucaitis to serve in oncology roles and regulatory affairs
07.22.16
Clinical Trials
|
Information Technology
|
R&D
An Adoption Divide: CDISC Standards
Survey addresses challenges, advantages, and costs associated with implementing clinical data standards
David A. Evans, managing director quality governance and regulatory compliance, Accenture Life Sciences
07.20.16
Drug Development
|
Drug Discovery
|
Industry News
|
Laboratory Testing
MilliporeSigma to Build Life Science Campus in Burlington, MA
Will serve as a hub for Merck KGaA’s North American life science business
07.20.16
Breaking News
|
Facilities
|
Industry News
|
Process Development
MilliporeSigma Relaunches Customer Collaboration Centers
Includes new concept and M Lab name
07.18.16
Validation
Good Enough for Government Work, So Why Change?
...
Emil W. Ciurczak, DoraMaxx Consulting
07.12.16
Breaking News
Ingenza Secures Innovation Funding to Expand codABLE Gene Design Algorithm
Novartis to Acquire Mariana Oncology for $1B Upfront
Bespak Enters Collaborations Focused on Advancing the Transition to Low GMP Propellants in pMDIs
CPHI North America to Address Key Trends in Contract Services for 2024 & Beyond
ProPharma & PBL Introduce Cell Factory Box
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
View More >