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
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
Rimini Street Expands Investment and Operations in Europe18.10.2017 22:00 | Pressemelding
Rimini Street, Inc., (Nasdaq: RMNI), a global provider of enterprise software products and services, and the leading third-party support provider for Oracle and SAP software products, today announced the appointment of industry leader Marc Chesover as general manager of Europe, the Middle East and Africa (EMEA). The Company also announced the launch of its French subsidiary, hiring of new staff and opening of its new office in Paris, France. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171018006654/en/ Rimini Street Expands Investment and Operations in Europe (Photo: Business Wire) Enterprise Software Veteran Leads EMEA Operations Rimini Street’s new general manager, Marc Chesover, will lead the Company’s sales and service delivery operations across EMEA, and the next p
Kite’s Yescarta™ (Axicabtagene Ciloleucel) Becomes First CAR T Therapy Approved by the FDA for the Treatment of Adult Patients With Relapsed or Refractory Large B-Cell Lymphoma After Two or More Lines of Systemic Therapy18.10.2017 21:43 | Pressemelding
Kite, a Gilead Company, (Nasdaq: GILD) today announced that the U.S. Food and Drug Administration (FDA) has granted regular approval to Yescarta™ (axicabtagene ciloleucel), the first chimeric antigen receptor T cell (CAR T) therapy for the treatment of adult patients with relapsed or refractory large B-cell lymphoma after two or more lines of systemic therapy, including diffuse large B-cell lymphoma (DLBCL) not otherwise specified, primary mediastinal large B-cell lymphoma (PMBCL), high-grade B-cell lymphoma, and DLBCL arising from follicular lymphoma (transformed follicular lymphoma, or TFL). Yescarta is not indicated for the treatment of patients with primary central nervous system lymphoma. This press release features multimedia. View the full release here: http://www.businesswire.com/news/home/20171018006639/en/ CAR T therapy is a breakthrough in hematologic cancer treatment in which
IFF Launches Re-Imagine…™ Programs to Tap Unmet Consumer Opportunities, Speed Innovation18.10.2017 20:15 | Pressemelding
Regulatory News: International Flavors & Fragrances Inc. (NYSE:IFF) (Euronext Paris:IFF), a leading innovator of sensory experiences that move the world, launched their Re-Imagine programs to accelerate innovation and increase agility to capture unmet opportunities in the changing food and beverage market. Based on a combination of future trends analysis, consumer insights, and a modernized cross-category development process, the programs guide the Company’s research and development efforts to ensure an innovation pipeline that addresses evolving consumer needs and desires. “The Re-Imagine programs area tangible expression of our commitment to advance taste for our customers – and consumers,” said IFF Chairman and CEO Andreas Fibig. “It is another way in which we show how we are dedicated to being our customers’ partner of choice as we progress on our business strategy, imbu
Sparkol Launches VideoScribe 318.10.2017 13:24 | Pressemelding
Introducing VideoScribe Version 3 by Sparkol. Already used by over two million people across the world to create engaging explainer videos, Version 3 of the highly intuitive software comes packed full of new features, including: An improved user experience and slick UI - animate easier than ever before Enhanced search - find exactly the image you need in record time Intelligent image recommendations - focus your creativity on your video instead Smoother performance - maximum productivity when using the software VideoScribe customers include the world’s largest brands (HP, BBC, Sky and the University of British Columbia), businesses across every sector, leading education providers, award-winning teachers, charities, campaigners, and coun
Piraeus Bank: Agreement for the Sale of Serbian Operations18.10.2017 13:06 | Pressemelding
Piraeus Bank announces that it has entered into an agreement to sell its Serbian banking and leasing operations to Direktna Banka A.D., a local Serbian banking group that has been strongly growing its presence in the market, for a total cash consideration between €58mn up to €61mn, depending on the financial performance of the divested assets until completion of the transaction, through a combination of direct sale price and simultaneous reduction of capital in Piraeus Bank Beograd AD. The transaction is conditional upon the usual corporate and regulatory approvals, including those of the National Bank of Serbia and the Hellenic Financial Stability Fund. The transaction represents another step towards the implementation of Piraeus Bank’s Restructuring Plan commitments, as those were agreed with the Directorate General of Competition of the European Commission. The transactio
Introducing InVision Studio, The World’s Most Powerful Screen Design Tool18.10.2017 13:01 | Pressemelding
InVision, the product design platform powering the world’s best digital experiences, today introduced Studio, a powerful new tool that will change the way screen design is done. InVision Studio was created by working closely with the world’s best design teams and finding inspiration in how they create beloved digital products. The launch of Studio comes at a time when modern organizations are shaping and redefining entire markets through their focus on digital customer experience. InVision already powers the product design process of more than 3 million people at tens of thousands of companies, including eighty percent of the Fortune 100 and brands like Airbnb, Uber, HBO, Amazon, IBM, Nike, and Slack. This new product reflects a major evolution of the digital product design workflow. With Studio, InVision has developed an end-to-end platform for designing digit
I vårt presserom finner du alle våre siste saker, kontaktpersoner, bilder, dokumenter og annen relevant informasjon om oss.Besøk vårt presserom