Apr 2013

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The draft for Israeli arrangements law for 2013 includes a special chapter about Clinical Trials. The goal is to improve the interfaces between the biotech industry and the regulatory authorities as for conducting clinical trials in human beings, by evaluating the international standards for this process and improving the professional capabilities of the Ministry of Health in the approval process, control and supervision and transparency.

A seminar about the new Israeli Ministry of Health guideline for production and import of experimental drugs (QP) was held on April 25th at World Courier offices in Holon. The seminar dealt with the new guideline issued on April 14th and its implications on the clinical research arena in Israel.

IATI-BIOMED June 10-12 to be Crowd-Driven. The Israel Advanced Technology Industry (IATI) is taking the innovation conversation to the next level at its 12th annual IATI-BioMed Conference, and is inviting participants to take the stage and present their latest, most cutting edge developments in Life Sciences to date. For the first time ever, Israeli and international Biomed companies, scientists and entrepreneurs will be given the Chance-To-Speak and present their latest innovations at the IATI BioMed Conference, simply by submitting a 200 word abstract on the topic they wish to showcase.

BLOOMBERG RANKS ISRAEL 1ST IN R&D INTENSITY WORLDWIDE. Bloomberg news recently issued a ranking of the world’s most innovative countries based on seven of quantitative parameters.  In the area of R&D intensity Israel ranked 1st in the world and 7th in the world in high-tech density. Overall the country ranked 32nd with the first five countries being the US, South Korea, Germany, Finland and Sweden.

What Could Proposed Changes to the Common Rule Mean to sites, Sponsors and IRBs? The U.S. Department of Health and Human Services has proposed changes to the Common Rule. These changes could result in an overhaul of regulatory requirements for human research.

FDA requests $4.7B budget to ensure safety of food supply, modernize medical product safety. The FDA is requesting this money to protect and promote the public health as part of the President's fiscal year (FY) 2014 budget. Industry user fees would fund 94% of the proposed budget increase, including new fees to support the landmark Food Safety Modernization Act (FSMA) and strengthen the FDA's ability to oversee imported food.

A seminar about the Role of Clinical QP (Qualified Pharmacist) will be held on May 23rd at Machon Ayalon in Rehevot. The seminar will discuss the role of the QP during the process of production and import of experimental medical products in Israel. The seminar is organized by CTrials and sponsored by inPACK – Clinical Supply Management.