regulatory affairs News

Leading provider of Oracle's clinical trial, data, and dug safety software will discuss why and how Empirica Topics should be implemented and used to strengthen an organization’s pharmacovigilance systems and processes.

Opening of new global base follows year of exceptional revenue growth

Badri Rengarajan, M.D., Medical Director, will present in the modeling and simulation tools to improve Phase III success session.

Synowledge is a global provider of drug safety, regulatory affairs and related IT solutions to small, mid and large sized pharmaceutical and biotechnology companies.

The Educational Services division of UK based MNC,Helix Research Center has announced Clinical Research Certificate Courses with 6 months Internship for the Life Sciences aspirants in all major cities in India

ELC GROUP Advisory Board’s Dr. Paolo Biffignandi to write opinion column for industry leading publication

Africa Health Research Organisation and Helix Research Center have announced Clinical Research Training Programs for the Life Sciences Aspirants and Corporates in the Africa and Europe

Sentrx, the leading provider of drug safety services to the life sciences industry, is pleased to announce the promotion of Michael O’Gorman from CFO to President & General Manager, effective immediately.

World-renowned physician Dr. Paolo Biffignandi joins ELC GROUP’s Advisory Board

Manufacturers and registration holders of traditional herbal medicinal products (THRs) agreed to join forces in an association whose functions would include campaigning for the safety of herbal medicinal products.

Leading provider of Oracle’s clinical trial, data, safety, and pharmacovigilance systems will discuss the new Individual Case Safety Report (ICSR) international standard and upcoming reporting changes, and how to comply with them using Argus Safety

Regulatory Resources Group (RRG), Surrey, England recently won the support category at the inaugural Regulatory Affairs Awards ceremony during a Gala Dinner at the TOPRA Annual Symposium in London.

Educational Services Division of UK based MNC,Helix Research Center has announced Coorespondence Certificate Courses in Clinical Reseatch for the Doctors,Nurses,CRAs,CRCs and Life Sciences Aspirants seeking Careers in Clinical Research Worldwide

UK based MNC,Helix Research Center has announced CRO and GCP Training Services for the Global Biopharmaceutical,Medical Device ,Cosmetic Industry,WHO,NIH etc and Clinical Reseatch Professionals respectively in BRICS Nations

Portugal based Yabulu and United Kingdom based Helix Research Center Ltd have announced Pharmacovigilance Training Programs,both for Freshers as well as working Professionals Worldwide.

Helix Research Center Ltd has announced Clinical Research Corporate Training Offerings Worldwide ,for Pharmaceutical,Biotechnology,Medical Device and Cosmetic companies ,Investigative Sites,Ethics Committees ,Govt ,Non Govt bodies doing Research.

"These short term training programs are quite helpful for the professionals and students in the clinical research and quality assurance field, who can't attend regular training programs.",said Mr.Kamal Shahani, Director Cliniminds.

Samantha Ng, Senior Recruitment Consultant joins CK Clinical heading up the Regulatory Affairs recruitment Team. Having worked in the Pharmaceutical recruitment field since 2003, Sam is a real asset to the team.

Pharmacovigilance gaining in importance after Vioxx problems-our new report analyses post-marketing assessment from the present onwards-Pharmacovigilance has been expanding in recent years, as companies are required to monitor drug safety post launch

CK Clinical are now using Twitter to keep job seekers and candidates up to date with vacancies as soon as they come in

Natural Health, Beauty and Personal Care Products consultant Idea MKT Solutions launches its new corporate image at www.ideamktsolutions.com

Troubled e-clinical specialist Datatrak International (Cleveland, Ohio) could be up for sale shortly, depending on the outcome of a review of strategic options now under way.

In the latest of five acquisitions, Worldwide Clinical Trials (Beverley Hills, California) has completed the purchase of Serbian CRO MediQuest (Belgrade).

Canadian CRO Algorithme Pharma (Laval, Quebec) has acquired a US clinical research centre from Bioanalytical Systems (BASi - West Lafayette, Indiana) for US$850,000 in cash.

US e-clinical specialist Datatrak International (Cleveland, Ohio) has decided to close its office in Bonn, Germany. Global help-desk services previously carried out by the office will now be provided from the company’s Cleveland headquarters.

Report Buyer, the online destination for business intelligence for major industry sectors, has added a new report offering invaluable information about the pharmaceutical regulatory affairs in the EU and US.

Today a small delay in gaining market access means huge loss in terms of market share and revenue generated. The key to success for pharmaceutical companies lies in obtaining timely marketing approval from regulators.Regulatory Affairs Outsourcing...

Regulatory Affairs consulting agency launches new website for marketing their outsourced compliance and regulatory affairs services targeting pharmaceutical, healthcare, biotech and medical companies.

Veeda Oncology (Columbus, Ohio) has acquired French cancer trials specialist Biologie et Industrie for an undisclosed sum.

Quintiles Transnational (Research Triangle Park, North Carolina) has signed an agreement to acquire Eidetics (Boston, Massachusetts), a privately held healthcare market research and consulting firm. Financial terms were not disclosed.

Pharmaceutical services company i3 (Basking Ridge, New Jersey) has acquired Russian CRO Lege Artis (Moscow). Financial terms were not disclosed.

Mixed results for Novartis’s first-in-class direct renin inhibitor, Rasilez (aliskiren), have been reported from the ALLAY study at the American College of Cardiology meeting in Chicago, US.

Parexel International (Boston, Massachusetts) has sold its stand-alone bioanalytical laboratory in Poitiers, France, to privately owned Indian CRO Synchron Research Services (Ahmedabad, Gujarat)

Quintiles Transnational (North Carolina) has signed an agreement with Medca Japan to provide central laboratory services in Japan. Quintiles will have its own staff at the Medca Japan laboratory in Saitama, a city in the Greater Tokyo area

QPS (Newark, Delaware) has acquired early-phase specialist Bio-Kinetic Clinical Applications (Springfield, Missouri). Bio-Kinetic has a 240-bed Phase I facility - one of the largest in the US owned by an independent CRO.

US biotechnology company GeoVax Labs’ (Atlanta, Georgia) HIV/AIDS vaccine is expected to enter Phase IIa human trials in mid-2008.

Polish CRO KCR (Warsaw) has acquired its Czech counterpart DUX Consulting (Prague). The value of the transaction was not disclosed.

Quintiles Transnational (Research Triangle Park, North Carolina) is to expand its global central laboratories and clinical development service (CDS) units in Beijing, China.

The US Food and Drug Administration has lifted its clinical hold on Vion Pharmaceuticals’ Phase III trial of its lead anti-cancer agent, Cloretazine (VNP40101M), in combination with Ara-C (cytarabine) in relapsed acute myelogenous leukaemia (AML).

US CRO Clinsys Clinical Research (Bedminster, New Jersey) and its French counterpart ITEC Services (Cenon, Bordeaux) have entered into a strategic alliance agreement.

PPD (Wilmington, North Carolina) has appointed Dr Philip Mathew as director of strategic development, to lead its Phase II-IV operations and expansion in India.

US cancer biotechnology company AVEO Pharmaceuticals (Cambridge, Massachusetts) has signed a collaborative agreement with Eli Lilly to use AVEO's Human Response Platform in a pilot project.

Covance (Princeton, New Jersey) has purchased from Eli Lilly a partially constructed insulin manufacturing facility on a 47-acre site in Prince William County's technology park (Virginia, US).

Private equity firm Sequoia Capital has invested Rs 1 billion ($25 million) in Indian CRO GVK Biosciences (Hyderabad). GVK BIO plans to use the funds to build a state-of-the-art campus on a 25-acre site at Hyderabad.

UK CRO Chiltern International (Slough, Berkshire) has acquired the independent US CRO Clinical Trial Management Services. Terms were not disclosed.

Targeted Genetics (Boston, Massachusetts) says that final tests support earlier indications that a patient death during a trial of its injectable anti-arthritis drug, tgAAC94, was not caused by the drug.

MDS Pharma Services (King of Prussia, Pennsylvania) has expanded its central lab operations in China, moving to a new, 25,000 sq ft facility near Beijing airport.

Quintiles Transnational (Research Triangle Park, North Carolina) has acquired Central American CRO Bio-Trials. The purchase was made by Quintiles’ Latin American subsidiary, based in Buenos Aires, Argentina.

Isotechnika (Edmonton, Canada) has received permission from the US Food and Drug Administration for the long-term use of ISA247 for the prevention of rejection in patients currently participating in its Phase IIb kidney transplant (PROMISE) trial.

The US Food and Drug Administration has sent a warning letter to Sanofi-Aventis, detailing failings in Aventis’s oversight of investigators involved in a clinical trial of the antibiotic Ketek (telithromycin) in 2001-02.