Clinical and Regulatory Operational Excellence Forum

Interview with programme committee member Hans van Bruggen, MSC, Senior Regulatory Affairs Consultant, eCTDconsultancy B.V., Netherlands

1. Innovative technologies are expected to take clinical development, licensing, and other regulatory processes to the next level in the future. What do you see are the biggest challenges facing companies when trying to cope with continued data growth in a fast changing environment? Pharmaceutical companies are heavily regulated and introducing change needs proof of acceptance by the authorities. The chance that authorities do not agree with that change makes the industry risk averse. Changes in a stable GxP environment are almost by default seen as a risk, however, not adapting to new technologies should also be seen as a risk! Therefore, ICH developed the ICH Q8, Q9, Q10, Q11, and Q12 guidelines, to anticipate change and implement changes much faster, with less of a regulatory burden. Nevertheless, industry is not picking up with the desired pace. Why not? More>>

Clinerion expands team and moves to new headquarters in Basel

Clinerion’s move to new headquarters is driven by growth in its business and its team, and matches the expansion in its international network of partner hospitals.

Clinerion is moving to new offices in Basel, Switzerland. Following strong expansion in its business, the company is in the process of growing its global team. In the six months leading up to the start of 2019, the company expects to have added several additional new positions. Staffing is increasing in all areas of the company, from Customer Solutions to Site & Patient Network Development, from Software Development to Data Analytics and Marketing. More>>

ACG to Showcase its Range of Capsules and Engineering Solutions at Supply Side West, Las Vegas

ACG, the only supplier in the world offering end-to-end manufacturing solutions for the pharmaceutical and the nutraceutical industries, will be exhibiting its wide range of Engineering and Capsules solutions at this year’s Supply Side West, Las Vegas. At ACG’s booth, the visitors will be able to see the synergies created with coupling ACG’s Capsules and Engineering products, thereby leveraging the many benefits of integrated manufacturing. More>>

Recro Gainesville Adds New Facility, Broadens Capabilities With High-Potent Processing on Deck

Gainesville, Ga., Nov. 5, 2018 (Business Wire) – Recro Gainesville has added a 24,000-square-foot facility, which includes high-potent material processing space, near its existing 97,000-square-foot contract pharmaceutical development and manufacturing plant. The company is a wholly owned subsidiary of Recro Pharma, Inc., and a leading provider of solid oral dose development and manufacturing services for the pharmaceutical industry. More>>

Sharp announces preferred partner agreement with Berkshire Sterile Manufacturing

Sharp, a global leader in contract packaging and clinical supply services, part of UDG Healthcare plc, has confirmed a preferred partner agreement with innovative sterile manufacturer Berkshire Sterile Manufacturing (BSM). More>>

Wickham Laboratories Ltd to Exhibit at Pharmig 2018

Wickham Laboratories will be exhibiting at Pharmig’s 26th annual conference held on the 28th & 29th November at the Belfry Hotel, Nottingham.

This year’s event will bring together an array of industry experts and regulators to discuss the latest research and findings within the pharmaceutical microbiology industry. More>>

Temperature Controlled Logistics returns with a top schedule for 2019

The 18th annual Temperature Controlled Logistics Conference will bring together supply chain, logistics and quality experts from around the globe to experience four days of ‘unmissable’ workshops, case studies, panels, interactive discussion groups and technology showcases. More>>

BioIVT Acquires Biological Specialty Corporation, Adds Donor Centers and Increases Its Immune Cell Capacity

Acquisition increases BioIVT’s supply of leukopaks, plasma and sera, and enhances its ability to support the in vitro diagnostic market

BioIVT, a leading provider of research models and services for drug and diagnostic development, today announced that it has acquired Biological Specialty Corporation (BSC), a supplier of human blood products and components to the life sciences research community for more than 37 years. BSC is headquartered in Colmar, PA, with two additional FDA-registered donor centers in Allentown, PA and Reading, PA. More>>

Charles River to Present Collaborative Methods at Neuroscience 2018

Charles River Laboratories International, Inc. (NYSE: CRL) today announced that its team of neuroscience drug discovery experts will present 26 scientific posters, both independently and collaboratively with clients, at Neuroscience 2018, the 48th annual meeting of the Society for Neuroscience (SfN). The meeting, which brings together more than 30,000 researchers from 80 countries, will take place from November 3-7, in San Diego, California. More>>

Charles River and Distributed Bio Enter Exclusive Partnership to Create an Integrated Antibody Discovery and Development Platform

New partnership allows Charles River’s clients access to Distributed Bio’s antibody discovery platforms

Charles River Laboratories International, Inc. (NYSE: CRL) today announced that it has entered into an exclusive partnership with Distributed Bio, Inc., a leader in the computational design and optimization of antibody discovery platforms. More>>