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INDUSTRY NEWS AND PRESS RELEASES
 

Zenith Technologies Wins ‘Supplier of the Year’ at Pharma Industry Awards 2018

Zenith Technologies, a world leader in delivering manufacturing software to the life sciences industry, has been named ‘Pharma Supplier of the Year’ at the prestigious 2018 Pharma Industry Awards. More>>

 
phone +353 (0) 21 4370 200
email info@zenithtechnologies.com
email Unit 4, Portgate Business Park, Raffeen, Monkstown, Co. Cork, T12 RP29, Ireland
 

Zenith Technologies Launches Virtual Manufacturing System Training Service

Zenith Technologies, a world leader in delivering GMP manufacturing software solutions to the life sciences industry, has launched a new virtual customised training service to tackle critical gaps in industry manufacturing software and process training. More>>

 
phone +353 (0) 21 4370 200
email info@zenithtechnologies.com
email Unit 4, Portgate Business Park, Raffeen, Monkstown, Co. Cork, T12 RP29, Ireland
 

Digital Manufacturing is a top priority for Life Sciences according to Zenith survey

Zenith Technologies, a world leader in delivering GMP manufacturing software solutions to the life sciences industry, recently conducted an industry survey that suggests the digital manufacturing is a top priority. More>>

 
phone +353 (0) 21 4370 200
email info@zenithtechnologies.com
email Unit 4, Portgate Business Park, Raffeen, Monkstown, Co. Cork, T12 RP29, Ireland
 

Nemera organized an expert review on the present and future of inhalation products

“Connectivity in every new inhalation device?” This topic was one of those discussed with different inhalation experts - Manfred Keller, Pascal Cavaillon and Henry Chrystyn – during a round table organized by Nemera in Paris to review the advantages and limitations of inhalation devices. More>>

 
phone +33 4 74 94 06 54
email information@nemera.net
web www.nemera.net
email 20 avenue de la Gare, 38290 – La Verpillière, France
 

Datwyler celebrates official opening of its new production plant with First Line standard in Middletown, Del

• The new facility in Middletown, Del., is Datwyler’s third facility with First Line standard which will be catering to the markets in North and South America • Approximately 120 jobs will be created, with the majority staffed from the local community • With the Middletown facility, Datwyler will be able to increase its global First Line production by 50 percent by 2020 • First Line is specially designed to manufacture biotech and pharmaceutical elastomer components in a fully integrated good manufacturing practice (GMP) environment More>>

 
 

Digital Health and Wearables

Tomorrows Future Today

• Datwyler uses strategic partnerships to develop new solutions in the fields of wearables and digital health. • The company’s health care offering is always designed towards improving the comfort of patients during treatment. • The product portfolio and innovative healthcare solutions will be presented at several important trade fairs of the medical sector. More>>

 
 

CHDI Foundation extends collaboration with IRBM to accelerate development of Huntington’s disease therapeutics

IRBM, a global contract research organization (CRO), has strengthened its position in neurodegenerative disease research following an extension of its long-standing collaboration with CHDI Foundation, a nonprofit biomedical research organization exclusively dedicated to collaboratively developing therapeutics that substantially improve the lives of those affected by Huntington’s disease (HD). More>>

 
 

2019 Pharmapack Awards

Pharmapack Europe have announced entries for the 2019 Pharmapack Awards are now open across both the ‘Exhibitor Innovation’ and ‘Health Products’ categories with a closing date of 30th November 2018. The Health Products category will include two winners with one for Patient-Centric Design – which is launched in partnership with HCPC Europe (Healthcare Compliance Packaging Council of Europe) – and a second introduced alongside Adelphe for Eco-design in health packaging and drug delivery devices. Pharmapack Europe have also announced that they’re accepting applications for the start-up hub which provides young start-up companies servicing the pharma industry with the benefit of valuable networking and learning opportunities at half the price of a regular stand. More>>

 
 

Charles River Laboratories Continues Commitment to Oncology Drug Discovery

Team of oncology experts expand data in Tumor Model Compendium and present strong portfolio at industry conferences

Charles River Laboratories International, Inc. (NYSE: CRL) today announced new additions to the Tumor Model Compendium. Charles River’s Compendium provides access to a comprehensive collection of well-established tumor models for early-stage oncology research. More>>

 
phone +1.877.CRIVER.1
email askcharlesriver@crl.com
web www.criver.com
email Charles River Laboratories International, Inc. 251 Ballardvale Street Wilmington, MA 01887
 

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>>

 
phone +41 61 225 51 51
web www.diaglobal.org
email Kuechengasse 16, 4051 Basel, Switzerland
 
 
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News and Press Releases

Digital Manufacturing is a top priority for Life Sciences according to Zenith survey

Zenith Technologies, a world leader in delivering GMP manufacturing software solutions to the life sciences industry, recently conducted an industry survey that suggests the digital manufacturing is a top priority.
More info >>


White Papers

Recommendations for Implementing Assessment Criteria Guidelines in Lymphoma and Chronic Lymphocytic Leukemia Clinical Trials

Perceptive Informatics

Standardized assessment criteria are becoming increasingly important in obtaining valid outcomes in oncology clinical trials. While standardized criteria encourage a more uniform approach to assessing clinical trial data, they are often subject to the interpretation of the user. These differences in interpretation, while seemingly minor, can have a major impact on assessments. The most commonly used standardized criteria for lymphoma have been no exception. Differences such as minimum new lesion size, lymph node normalization size requirements, inclusion of extranodal lesions and assessment of organomegaly can have a profound effect on overall response. Additionally, heightened scrutiny of the assessment criteria used in a given protocol can lead to questions about a drug’s efficacy if not applied correctly according to regulators’ interpretation.
More info >>

Industry Events

Clinical Trial Supply Europe 2019

13-14 March 2019, Milan, Italy

Following on from our largest and most engaging meeting to date, Clinical Trial Supply Europe will be returning to Milan for its 20th year in 2019! The 19th annual edition welcomed pharmaceutical companies across Europe who got together to share knowledge and issues regarding clinical trial supplies, both with regards to operational and technological challenges. Over the two days, delegates discussed issues which affected their business in our dedicated operational and technological streams.
More info >>

 
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