25th Annual DIA EuroMeeting - Session Overview - 5-6 March 2013 Amsterdam

Session Overview - March 5 & 6
RAI Center
Europaplein
1078 GZ Amsterdam
Netherlands

Accepting onsite registrations!


The themes for the EuroMeeting 2013 include the professional disciplines of regulatory affairs, safety and efficacy for human medicines, diagnostics and devices. Much innovation will be fostered by interaction between disciplines and jointly between the stakeholders of healthcare innovation such as industry professionals, academia, regulatory competent authorities, patient representatives, and the general public.

Theme 1 | Health Technology Assessment (HTA)/Sustainability of Health Systems in EuropeLuca De Nigro, Coordinator, Drugs Monitoring Registers Unit, Italian Medicines Agency, Italy
Lidia Retkowska-Mika, Head Legal Unit, Office for Registration of Medicinal Products, Poland

Theme 2 | Development of Medicinal Products for Paediatric, Elderly and other Special Populations
Gesine Bejeuhr, Regulatory Affairs/Quality, vfa Research-Based Pharm Companies, Germany
Markus Pasterk, COO and VP of Science, International Prevention Research Institute, France

Theme 3 | Legal/Transparency/Risk & Litigation
Burkhard Sträter, Lawyer, Kanzlei Sträter, Germany
Theme 4 | PharmacovigilanceVicki Edwards, Senior Director, European Pharmacovigilance, Abbott, UK
Jan Petracek, CEO, Director of Pharmacovigilance Services, Pharminvent, Czech Republic

Theme 5 | Clinical Research and DevelopmentAndrei Kravchenko, Head of Office, Harrison Clinical Research, Ukraine
Nermeen Varawalla, Founder and CEO, ECCRO, UK

Theme 6 | Quality (including Falsified Medicines)Susanne Keitel, Director, European Directorate for the Quality of Medicines and Healthcare (EDQM), Council of Europe, EU
John Kerridge, Quality Leader, EU QA External Relations, Lilly, France

Theme 7 | Devices & In Vitro Diagnostics and Combination ProductsShayesteh Fürst-Ladani, Managing Director, SFL Regulatory Affairs and Scientific Communication, Switzerland
Siniša Tomić, Counselor for European Affairs, Agency for Medicinal Products and Medical Devices, Croatia

Theme 8 | eHealth
Hans van Bruggen, Director, eCTDConsultancy, Netherlands
Rob Middel, Head of R&D Business Development, Pharmaceutical R&D Quality & Compliance, Senior Director Janssen Biologics, Netherlands

Theme 9 | Involvement of Patients and Academia as Experts in the Drug Approval ProcessGonzalo Calvo Rojas, President of the European Association for Clinical Pharmacology and Therapeutics (EACPT), Spain
Judith Creba, Head EU Liaison & Policy, Novartis, Switzerland

Theme 10 | Known Active SubstancesMaren von Fritschen, Director Regulatory Affairs, PharmaLex, Germany
Marta Marcelino , Member CMDh, Medicines Evaluation Department, National Authority of Medicines and Health Products (INFARMED), Portugal

Theme 11 | Antiobiotics/Anti-Infective TreatmentsRichard Bergström, Director General, European Federation of Pharmaceutical Industries and Associations (EFPIA), Belgium

Theme 12 | Effectiveness and Efficiency of the EU Regulatory system - Does new legislation enable innovation and facilitate co-operation?Isabelle Stöckert, Head Global Regulatory Affairs Europe/Canada, Bayer Healthcare Pharmaceuticals, Germany
Melek Bostanci Önol, Head of Regulatory Affairs & Quality Assurance, Boehringer Ingelheim, Turkey

Theme 13 | GlobalisationChrister Backman, Member CMDh, EU Coordinator and Senior Expert, Medical Products Agency, Sweden
Ning Xu, Executive Director, Head of CDS, Covance Pharmaceutical R & D, China

Theme 14 | Regulatory ScienceChristine Gispen-De Wied, Clinical Coordinator; Member of SAWP, Medicines Evaluation Board (MEB), Netherlands
Hubert Leufkens, Chairman, Medicines Evaluation Board (MEB), Netherlands

Theme 15 | Growing Demand for Quantitative Approaches in Drug DevelopmentJürgen Kübler, Global Head, Clinical Sciences, CSL Behring, Germany
Steven Teerenstra, Statistical Evaluator, Medicines Evaluation Board, Biostatistics Working Party (BSWP), Netherlands

 

Theme 16 | Non-Clinical
Jan Willem van der Laan, Senior Pharmacological Toxicological Assessor, Medicines Evaluation Board (MEB), Netherlands

Theme 17 | The IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for PatientsHans Lindén, Leader European Projects , European Federation for Pharmaceutical Sciences (EUFEPS), Sweden

See also:
Searchable Program
List of Program Committee Members

Latin America: get the latest clinical information, knowledge resources and regulatory news in the life sciences and health care industry with DIA electronic membership

Electronic Membership now available in Latin America! Dear Colleague, You asked, we delivered! It is my pleasure to invite you to join DIA as a Member.  DIA’s electronic Membership provides with online tools and digital access to an outstanding collection of tools and resources to keep you ahead of the curve on the latest clinical information, knowledge resources and regulatory news in the life sciences and health care industry – all for just $35 a year. SAVE THE DATES In addition, as part of your membership you have access to all the below tools and resources. To register online, click here or to download a form, click here. Enter your country and choose eMembership from the dropdown list. eMembers-only registration discounts on DIA Latin America conferences and over 200  DIA offerings across the globe and online New! Members-only free archived webinars. Take advantage of a hot topic webinar as a complimentary member benefit – without leaving your desk New! DIA Online Member Directory. Network locally and globally, share documents and discussions, connect with colleagues and create your own network of colleagues and industry thought leaders. Digital Subscription (6 issues each) to: New in 2013! Subscription to Therapeutic Innovation & Regulatory Science publication, DIA’s peer-reviewed, scholarly journal (formerly the Drug Information Journal) Global Forum – your association digital news magazine featuring practical tips, regulatory and global industry updates Online Communities and DIA ConneX: Members-only professional networking platform and Special Interest Area Communities (SIACs) – DIA’s discipline specific groups that share best practices and the latest information related to your field DIA Online Career Center– your source to find and list employment opportunities If you have any questions regarding membership or joining, please contact us at membership@diahome.org. Sincerely, Alejandro Bermudez-Del-Villar, MA/IBBD Latin America & Global Program Development Coordinator Alejandro.Bermudez@diahome.org

CALL FOR ABSTRACTS: #DIA2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science - deadline 9/12

http://www.diahome.org/en/Get-Involved/Submit-Abstracts/Submit-a-New-Abstract/Select-Meeting/Meeting-Details.aspx?productID=30075&productcode=13001

Meeting Date:
6/23/2013 8:30:00 AM - 6/27/2013 12:45:00 PM

Location:
Boston Convention and Exhibition Center 415 Summer Street, Boston, MA 02210 USA

Overview:

Call for Abstracts for DIA 2013 49th Annual Meeting opens as of August 6, 2012 with a deadline of September 12, 2012

· Read the Call for Abstracts to review specific guidelines for submitting an abstract for consideration

· Read Best Practices for submitting abstracts

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Science is the largest multidisciplinary event that brings together a global network of professionals to foster innovation that will lead to the development of safe and effective health care products.

Through increased access to training and expanded professional networking opportunities, DIA 2013 will:

· Provide a global unbiased platform to raise the level of discussion to facilitate innovation that will change the future of health care

· Provide comprehensive coverage of the full development and life cycle management process for all health care products Enhance your working relationship with colleagues, both locally and internationally

· Offer a holistic and integrated approach to the development and life cycle management of regulated health care products

Ultimately, collaboration is about mutual respect, working together, and being open to new ideas and learning from each other. To that end, DIA 2013 provides the best opportunity to meet with people from around the world, share your views and knowledge, network, and build new relationships.

Learning Objective:
At the conclusion of this meeting, participants should be able to:

• Describe the current regulatory and public policy environment pertaining to pharmaceuticals with an emphasis on the Food and Drug Administration;
• Discuss the international regulations and economic factors that impact the global biopharmaceutical industry;
• Recognize the challenges facing the FDA and the pharmaceutical industry in areas such as research study design and statistical methodology;
• Recognize state-of-the-art clinical and statistical systems and implementations;
• Recognize the written and communication skills needed to promote your career and your companys objectives;
• Enhance your working relationship with colleagues, both locally and internationally;
• Describe legal, advertising, and marketing issues related to providing product information;
• Discuss statistics, economics, and quality of life science;
• Enhance your knowledge of risk assessment and management in the areas such as computer systems validation and drug safety and pharmacovigilance;
• Discuss issues in safety reporting, data analysis, epidemiology, and regulations regarding adverse events.

Target Audience:
This program is designed for the full continuum of disciplines in the pharmaceutical and related industries to improve your understanding and skills as related to issues and solutions for a variety of pharmaceutical development interest areas.

The Commissioner’s Fellowship Program: Fostering Scientific Talent at FDA - from FDA Voice

As the May 25th application deadline for the Commissioner’s Fellowship Program rapidly approaches, it’s time to acknowledge the tremendous contributions our Fellows and their FDA mentors have made in support of FDA’s Advancing Regulatory Science effort. I also want to highlight the opportunities the Fellowship Program offers health care professionals, scientists, and engineers who may not have considered FDA in planning their career path.

FDA launched the Fellowship Program in October 2008 to achieve three essential goals: to attract outstanding scientists who could tackle Center-selected and targeted research or regulatory issues, to train these scientists in regulatory science, and to help build our scientific staff. Since then, FDA has graduated 48 Fellows from the class of 2008 and 50 from the class of 2009. The class of 2010 will graduate this coming Sept. 25th.

This two-year program is open to scientists and medical professionals with doctoral level degrees, although we also welcome applicants with a bachelor’s in an engineering discipline. Fellows pursue a rigorous regulatory science curriculum and conduct research that addresses a scientific or regulatory gap, under the mentorship of an FDA senior scientist.

more at FDA Voice...
http://blogs.fda.gov/fdavoice/index.php/2012/05/the-commissioners-fellowship-program-fostering-scientific-talent-at-fda/