November 2015

The FDA and the Office for Human Research Protections (OHRP) have issued draft guidance titled, “Minutes of Institutional Review Board (IRB) Meetings:  Guidance for Institutions and IRBs”.  This draft guidance was prepared jointly by FDA and OHRP and is intended for institutions and IRBs responsible for oversight of human subject research under FDA and HHS regulations.  This joint draft guidance is intended to assist institutions and IRBs responsible for preparing and maintaining minutes of IRB meetings.  The draft guidance describes requirements for minutes and provides recommendations for meeting the regulatory requirements for minutes.
 
LSIE 2015 , the 2nd International event for the Life Science and Technology Industrieswill take place  in David Intercontinental Hotel, Tel-Aviv on December 9-10, 2015. LSIE 2015 is an international event for the Life science industry which includes professional conferences, exhibition, business encounters, innovation and more. Conventions & Meetings within LSIE 2015 includes: MDDMI - The 6th Annual Conference for Medical Device Design & Manufacturing Industry, GCP - Clinical Trials, ITTN - The 3rd International Conference of the Israel Tech Transfer Organization (ITTN) and ManageMed - The 2nd International Conference for Hospital Management.
 
ISRANALYTICA 2016, The 19th Annual Meeting of the Israel Analytical Chemistry Society. The Conference and Exhibition will take place on January 19 & 20, 2016, in the David Intercontinental Hotel, in Tel-Aviv, Israel. More than 3000 participants have recently attended the conference, covering the academy, chemical industry, instrumental industry, major laboratories and companies in Israel. More than 70 vendors present their goods, accompanied by experts representing manufacturers and others. Analytical chemists from all over the world show great interest in this conference. 
 
The International Conference on Harmonisation (ICH) released its 11 June 2015 draft ICH E6 (R2) Step 2b, for comments by 31 Jan 2016. Consequently, CTrials seeks to form a comprehensive and unified response to the proposed updates. Those looking to hear more about these suggested changes, voice an opinion and have an effect our future ICH-GCP, are invited to our discussion meeting which will take place on the 3rd of January, 2016.

Israeli start-up uses Trojan horse technology to kill cancer cells. BioSight, a medical technology start-up, has developed a technology that enables leukemia patients to avoid the worst effects of chemotherapy. “Our interim results in a major study of patients with leukemia shows that our system yields the maximum efficiency from chemo, with a minimum of toxicity,” said Dr. Ruth Ben Yakar, CEO of BioSight. “Our method of using chemo does not cause brain damage or weaken blood cells,” with all its attendant phenomena, such as lethargy, loss of hair, etc.
 
Johns Hopkins University president visits Rambam Medical Center. Johns Hopkins University president Prof. Ronald Daniels bucked academia’s BDS movement and paid a visit to Rambam Medical Center in Haifa to strengthen ties with the facility as a medical center similar to his own. Meeting with Rambam director-general Prof. Rafael Beyar and outstanding researchers and physicians recently, Daniels said Rambam and the Baltimore, Maryland-based university have been cooperating on joint research and exchange visits for doctors and researchers for a decade, since Beyar was dean of the Technion- Israel Institute of Technology’s Rappaport Medical Faculty. Daniels visited Haifa two years ago to tour the Technion.
                       
Now live! Our new translations division of high quality certified medical and pharmaceutical translations. You are welcome to visit our new webpage: www.qt-translations.com