July 2014

An Iaraeli delegation will be participating in the international Baltic countries Biomedical Conference Life Sciences Baltics, which will take place in Vilnius on September 9th-11th 2014. This delegation is sponsored by the Lithuanian government. The Life Sciences Baltics conference, supported by EU funds, is part of a broader initiative by the Baltic countries to enhance the biomedical industry in the region. This international conference exposes the Baltic scientists, developers and professionals to the international biomedical community. It also presents the Baltic countries’ academic achievements, as well as the R&D, entrepreneurship and manufacturing abilities and skills in the biomedical field. The 1st Life Science Baltics conference attracted more than 800 international participants, among them a delegation of over 100 Israelis. 
 
Round Table: eCTD in Regulatory Submission – What Do I Need to Know? The IATI and Bioforum are holding a roundtable on the Ectd (electronic Common Technical Document) Regulatory Submission standard which is the common practice in vast majority of drugs/biologics regulatory submissions nowdays. eCTD sets forth a list of technical requrements which all of the submission documents must comply with. The event will be held on August 12 in Hertzliya Pituach.
 
FDA has issued draft Information Sheet Guidance on Informed Consent. This draft guidance is intended to assist IRBs, clinical investigators, and sponsors involved in clinical investigations of FDA-regulated products in carrying out their responsibilities related to informed consent. The guidance provides the Agency’s recommendations and requirements for informed consent to assure the protection of the rights and welfare of human subjects in clinical investigations. This guidance describes the basic and additional elements of informed consent and includes topics such as review of patient records, children as subjects, and subject participation in more than one study. The guidance is now available on FDA's website:
 
Israeli M&A Continues on Pace for a Record Year. As we move squarely into the second half of 2014, Israeli startups are experiencing what portends to be a record year. In fact, total transaction volume has already exceeded all that in 2013. In the first half of 2014, Israel has had 37 mergers, acquisitions, and IPOs. The average acquisition price an Israeli company fetched through June 2014 was $101.77 million.
 
Israel ranks 15th on the 2014 Global Innovation Index. The Global Innovation Index (GII) 2014, was launched this week in Sydney alongside a meeting of international business leaders. The index is co-published by the UN World Intellectual Property Organization, Cornell University, and INSEAD, a global business school. The index was developed together with the World Intellectual Property Organization Director General Francis Gurry. The top 20 innovative countries according to the index are: Switzerland, UK, Sweden, Finland, the Netherlands, United States, Singapore, Denmark, Luxembourg, Hong Kong, Ireland, Canada, Germany, Norway, Israel, South Korea, Australia, New Zealand, Iceland, and Austria.