Breaking News on Contract Research, Manufacturing & Clinical Trials

Regulatory affairs


Download now!Data sheet

A year on, EU GDP’s affect on European Pharma Distribution - World Courier

24-Mar-2014 - World Courier welcomed the EU GDP guidelines, which created a yardstick by which logistics providers could be measured and compared.  A year on from the draft publication it is now fully in force and there has already been an update...
Download now!Technical / white paper

Ensuring cold chain remains cold and controlled room temp remains controlled! - World Courier

24-Feb-2014 - The first of ten new vehicles have been delivered to World Courier Ground Europe, and in line with the requirements of the regulations for pharmaceutical distribution have undergone qualification testing for frozen, refrigerated and controlled room temperature conditions at extreme...
Download now!Application note


20-Jan-2014 - Recipharm Stockholm has risen to the challenge of increased regulatory and customer-based inspections by devising an audit system that enables the company to be in a state of continuous inspection readiness. Recipharm, one of the busiest and most highly regarded...
Download now!Case study

Clinical Document distribution - Secure and Automated - PharmaSOL

08-Jan-2014 - psiXchange automates the distribution of your safety related documents. The distribution engine handles country specific rules and user specific escalation paths, with full receipt tracking. Recipients don't have to learn a new system, and your internal overhead is dramatically reduced.psiXchange...
Download now!Technical / white paper

Applying a Health- and Science- based Risk Assessment for Multi-Product Biologics manufacturing - Fujifilm

18-Nov-2013 - Over the last 10-15 years, it has become common practice to manufacture biologics intended for clinical trials (Investigational Medicinal Products, or IMPs) in multi-purpose facilities.This flexibility has been a key enabler in ensuring a flow of novel products, frequently targeting...
Download now!Case study

Controlled Release and Bioavailability Enhancement -

28-Oct-2013 - Metrics provides product development that leverages proprietary pharmaceutical technologies in the areas of: •    Customized Controlled Release Drug Delivery •    Bioavailability Enhancement •    Taste Masking (liquid and solid presentations)When applied appropriately, these technologies can deliver therapeutic and convenience benefits to...
Download now!Data sheet

505(b)(2): 10 Years and Running with 300+ Approvals - Camargo

21-Oct-2013 - In 2003, the FDA unleashed the 505(b)(2) pathway. With a record 47 approvals in 2012, the pathway is helping product developers secure up to 7 years of market exclusivity.Visit us at AAPS booth 4304 and read our white paper to learn more.
Watch now!On-Demand Supplier Webinar

New Guidelines for Stabilization of Proteins by Freeze Drying: Formulation and Process Heresy - Baxter

17-Oct-2013 - Over the years a number of informal guidelines or “rules” for the formulation and processing of proteins for freeze-drying have been developed. However, in recent years it has become obvious that some of these rules need modification. In this presentation,...
Download now!Technical / white paper


23-Sep-2013 - To understand why there is so much buzz in the pharmaceutical world for a better HCV treat­ment, as with most things, you have to start with history. This article will highlight the history, why there is a growing need for...
Watch now!On-Demand Supplier Webinar

Biosimilars – Landmark Developments Point to the Future for Regulations and Analysis - SGS Life Science Services

30-Aug-2013 - 2013 is a landmark year for biosimilars, with the approval of the first biosimilar mAb and regulatory developments across the globe. Correctly interpreting the analytical requirements in these regulations is critical to demonstrate Biosimilarity. This webinar will review the evolution of...
Watch now!On-Demand Supplier Webinar

Exploring New Frontiers in Direct to Patient Home Delivery Services for Clinical Trials Materials - Marken

07-Aug-2013 - Exploring New Frontiers in Direct to Patient (DTP) Home Delivery Services for Clinical Trial Materials provides an in-depth look at reasons to consider a DTP solution. Included in the discussion are concerns with the traditional distribution channels, advantages and challenges...
Download now!Case study

Creating and capturing value for outsourcing pharmaceutical manufacturing - Recipharm AB

15-Jul-2013 - An efficient technology transfer process can create value as well as capture it for pharmaceutical companies and CMOs alike.Discover the mutual benefits of working with Recipharm. Because technology transfer has both legal and economic implications, working with an experienced outsourcing manufacturer...
Download now!Technical / white paper

Understanding the 505(b)(2) Approval Pathway - Camargo

11-Jun-2013 - When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...
Download now!Data sheet

505(b)(2): It’s A Different Animal - Camargo

13-May-2013 - 505(b)(2) is more than a regulatory pathway — for many, it’s a unique strategy that can often result in product approval with lower risk, reduced development cost and faster speed to market. So, is (b)(2) for you?
Watch now!On-Demand Supplier Webinar

Supply Chain Issues and Trends in Asia - Marken

02-May-2013 - Import/export of biological samples from China China: Large Pharma Reverse Logistics A Common Issue: Destruction of Drug in Taiwan J-GMP: How is GMP different in Japan? Korea: Biosimilars Hotbed India: Will Regulations Change to Allow Quicker Study Approval in 2013?
Download now!Case study

Increasing Accuracy, Not Costs - Mettler Toledo

11-Apr-2013 - Pharmaceutical manufacturers worldwide are turning to vision inspection as a way to safeguard their brands, keeping products with label and packaging defects from retailer shelves. One major pharmaceutical manufacturer came to Mettler-Toledo CI-Vision hoping to reduce the rate of defective...
Watch now!On-Demand Supplier Webinar

Industry Snapshot: Clinical Trial Trends Outline Complexity for Supply Chain - Marken

25-Mar-2013 - 2013 Industry trends driving the scientific, logistical and regulatory complexity of supply chain industry Implement clinical development methodologies for quality, relationships, and performance Strategies to optimize drug development to reduce global trial time and costs
Download now!Technical / white paper

What Makes 505(b)(2) Different? - Camargo

19-Mar-2013 - When it comes to developing a compound, the 505(b)(2) drug development pathway is not just a regulatory platform — it’s a different animal. This pathway offers a holistic approach for developing products that offer differentiated benefits with Lower Risk, Reduced...
Watch now!On-Demand Supplier Webinar

Optimizing your Strategy and Budget for Clinical Trial Supply Distribution - Marken

20-Feb-2013 - How to determine if a depot or direct to site shipments are more efficient Calculation based on a case study How to avoid delays and assure that your shipments arrives without delays and excursions
Download now!Technical / white paper

New European Offices, Thermal Packaging Alternatives Accommodate Specialized Needs of World Courier Biopharm Customers - World Courier

11-Feb-2013 - World Courier’s newly-expanded international network − now numbering 152 office locations in 52 countries − brings expertise, personnel and infrastructure closer to key customers in Switzerland and Austria with the recent opening of offices in Basel and Innsbruck.At the same...

Key Industry Events

Interphex 2014

New York, NY 10001 / Conference and exhibition

Read more

Access all events listing

Related News

Product Innovation