SynteractHCR Global Medical and Regulatory Affairs Expert Dr. Martine Dehlinger-Kremer Speaking at Nordic ePharma Day and Pediatric Drug Development Conferences in April
Martine Dehlinger-Kremer, Ph.D., global vice president for medical and regulatory affairs at international contract research organization SynteractHCR, will speak on topics of special interest to the international biopharma community at two conferences this spring. At Nordic ePharma Day, to be held April 21, 2016, in Copenhagen, Dr. Dehlinger-Kremer will present “The New EU Clinical Trials Regulation: What Are the Changes and What Will the Impact Be on Clinical Research in the European Union.” At the Pediatric Drug Development Conference of the Medicines for Children Research Network Hungary in Budapest from April 27-28, she will address the status of pediatric regulations and their impact on drug development for children today.
An expert in working with global regulatory organizations, Dr. Dehlinger-Kremer has more than 29 years of experience in the clinical research industry and has spoken, in both the US and Europe, on the new EU Clinical Trials Regulation multiple times in the past two years since it was initially put forth by the European Commission. The Regulation’s goal is to harmonize trial procedures and make Europe a more attractive location for conducting clinical trials – but it is not just a European issue as it will impact some initial considerations for trials in the United States, too. Dr. Dehlinger-Kremer’s presentation will provide an overview of the CT Regulation from the regulatory point of view, an introduction to national pilot phases, and also will identify some of the challenges the Regulation might bring.
In her role as chair of the Paediatric Working Group for EUCROF (European CRO Federation), Dr. Dehlinger-Kremer will open the conference as keynote speaker at 9:00 a.m. on the first day with a discussion entitled, “The EU Regulatory Situation, Ten Years after Paediatric Regulation,” which addresses the status of drug development for children now. Her experience in this area, in addition to serving as the EUCROF Pediatric Working Group chair, includes being a member of the working group of Enpr-EMA, the European Network of Paediatric Research at the European Medicines Agency, as well as a member of the EFGCP Children Working Party. In addition, she has an impressive background in multiple levels of pediatric drug development and has worked closely with authorities to help improve clinical research in children.
“With her extensive global industry and regulatory experience, Martine’s knowledge and expertise has augmented the consultative capabilities we offer clients globally, to support them through all stages of their drug development needs,” said SynteractHCR CEO Wendel Barr. “She is tireless in her quest to improve the drug development process for adults and children alike, and we are very proud that she is a thought leader for not only our company but for the international community at large.”
Dr. Dehlinger-Kremer has contributed to the global development of numerous products, including orphan drugs and biosimilars, from early development stages through clinical studies and final registration. She has participated in more than 100 New Drug Applications (NDAs) and Marketing Authorization Applications (MAAs), in the maintenance of products on the market, and in numerous clinical studies across all phases. She has co-authored numerous papers for industry and scientific publications and has chaired and participated in regulatory sessions at the European Medicines Agency (EMA), Drug Information Association (DIA), Partnership in Clinical Trials, ePharma Day, New Paradigms, Bio2Device Group, International Quality & Productivity Center (IQPC), and more.
About SynteractHCR ( www.synteracthcr.com )
SynteractHCR is a full-service contract research organization with a successful two-decade track record supporting biotechnology, medical device, and pharmaceutical companies in all phases of clinical development. SynteractHCR has conducted Phase I-IV studies on six continents and 60 countries, offering expertise across multiple therapeutic areas, with notable depth in oncology, immunotherapy, CNS, infectious disease, endocrinology, cardiovascular and respiratory, among other indications. With its “Shared Work – Shared Vision” philosophy, SynteractHCR provides customized services collaboratively and cost effectively, ensuring on-time delivery of quality data to help bring tomorrow’s treatments to patients.
Beth Walsh, 760-230-2424
Om Business Wire
(c) 2018 Business Wire, Inc., All rights reserved.
Business Wire, a Berkshire Hathaway company, is the global leader in multiplatform press release distribution.
Følg saker fra Business Wire
Registrer deg med din epostadresse under for å få de nyeste sakene fra Business Wire på epost fortløpende. Du kan melde deg av når som helst.
Siste saker fra Business Wire
JPMorgan Chase Bank announces the placement of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 19:40 | Pressemelding
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the placement of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest. The Bonds will be issued with an issue price of 100% and will redeem at par on 30 December 2020. The initial exchange price (the “Initial Exchange Price”) will
Boston Capital Announces Closing of Boston Capital Income & Value U.S. Apartment Fund17.7.2018 14:00 | Pressemelding
Boston Capital, the third largest owner of apartments in the U.S. with over $19.6 billion invested, is pleased to announce the final investor closing of Boston Capital Income and Value U.S. Apartment Fund (“BCIV”). BCIV, a discretionary multi-investor Luxembourg based fund vehicle, includes financial institutions, insurance companies, pensions, and family offices among its investors and will acquire over $350 million in apartment properties throughout the U.S. “We are very pleased to close BCIV, the latest in a succession of institutional investment vehicles through Boston Capital’s conventional apartment investment arm, Boston Capital Real Estate Partners (“BCRE”),” said Jeff Goldstein, COO and Director of Real Estate at Boston Capital. The Fund generates high current dividends and capital growth by acquiring and renovating Class B apartment properties located in major and secondary U.S. markets and by targeting a renovated rental price point well below new construction rates, which a
Amobee Wins Auction Process to Acquire Videology Assets17.7.2018 13:13 | Pressemelding
Singtel subsidiary Amobee, a leading global digital marketing technology company serving brands and agencies, today announced that it has emerged as the winner in the court supervised auction to acquire certain assets from Videology, a software provider for advanced TV and video advertising, for purchase price of approximately US$101 million1. The purchase price is subject to adjustments for accounts receivable at closing, estimated to be approximately US$20.9 million. The acquisition, following Videology’s voluntary Chapter 11 restructuring proceedings, includes Videology’s technology platform, intellectual property and certain other assets of estimated net book value of US$5.3 million2. Over the past decade, Videology has emerged as a leading provider of software that empowers advertisers and publishers to use data to optimize campaigns and spend across digital platforms and television. The addition of Videology’s capabilities will be a further boost to Amobee’s omni-channel platform
Lenovo Leaps Forward with Next-Generation ThinkAgile Composable Cloud Platform17.7.2018 12:00 | Pressemelding
Lenovo Data Center Group (HKSE: 992) (ADR: LNVGY), one of the fastest growing hyperconverged infrastructure (HCI) vendors according to IDC, – with HCI revenue growing at almost twice the market growth rate in Q1 2018 (149.1% compared to 76.3%)—is further expanding its ThinkAgile portfolio to provide an innovative solution for customers who desire the agility of the public cloud and the security of a private cloud. To address this growing customer trend, Lenovo – together with Cloudistics – has developed the ThinkAgile CP Series composable cloud platform, a ‘cloud-in-a-box’ that offers all of the conveniences and ease-of-use of a public cloud environment secured behind the customer’s own data center firewall. Lenovo ThinkAgile CP Series – with fully-integrated infrastructure, application marketplace and end-to-end automation of software-defined network, compute and storage – delivers a turnkey cloud experience that can be easily and centrally managed from anywhere through a software-as-
JPMorgan Chase Bank launches offering of cash-settled exchangeable bonds into Ping An Insurance (Group) Company of China Limited due 202017.7.2018 12:00 | Pressemelding
NOT FOR DISTRIBUTION IN OR INTO THE UNITED STATES OR TO, OR FOR THE ACCOUNT OR BENEFIT OF, U.S. PERSONS (AS DEFINED IN REGULATION S UNDER THE U.S. SECURITIES ACT OF 1933) OR IN OR INTO JAPAN, THE PEOPLE’S REPUBLIC OF CHINA, SWITZERLAND OR ANY OTHER JURISDICTION IN WHICH SUCH DISTRIBUTION WOULD BE PROHIBITED BY APPLICABLE LAW. JPMorgan Chase Bank, N.A. (the “Issuer”) today announces the launch of an offering of cash-settled exchangeable bonds due 2020 (the “Bonds”) in aggregate principal amount of up to approximately USD 350 million. The Bonds are referable to H-shares (the “Shares”) of Ping An Insurance (Group) Company of China Limited (the “Company”). Exchange rights in respect of the Bonds will be cash-settled only. The Issuer is rated A+ (Stable outlook) by Standard & Poor’s, Aa3 (Stable outlook) by Moody’s and AA (Stable outlook) by Fitch. The Bonds will be issued in principal amounts of USD 200,000 and integral multiples of USD 100,000 in excess thereof and will not bear interest.
Greene Tweed Achieves Nadcap Accreditation for Non-Metallic Materials Testing17.7.2018 11:01 | Pressemelding
Greene Tweed’s Central Engineering (CE) Materials Test Lab recently completed its final Nadcap accreditation audit for Non-Metallic Materials Testing (NMMT) of composite materials. This press release features multimedia. View the full release here: https://www.businesswire.com/news/home/20180717005200/en/ Greene Tweed Achieves Nadcap Accreditation (Photo: Greene Tweed) In support of Aerospace’s strategic initiative, this positions Greene Tweed as one of a select few aerospace companies who have attained this accreditation as validation of our materials testing capabilities and our position as a composite solutions provider. To achieve this standard, Greene Tweed’s CE lab completed a comprehensive audit against the highest standards for special process controls, test completion, and validation. This in-house accreditation adds to Greene Tweed’s responsiveness to new product development requests while expanding production material and customer product certification capabilities. It also