Showing posts with label regulatory. Show all posts
Showing posts with label regulatory. Show all posts

Thursday, April 18, 2013

Speak at the EuroMeeting 2014


 
26th Annual EuroMeeting 2014
March 25-27 | Vienna, Austria
Abstract submission deadline: May 29

Submit your presentation, session or tutorial abstracts for DIA’s Annual EuroMeeting and share your research with more than 3,000 professionals from around the world.

Session Abstract
A session abstract is a 90-minute session concept delivered lecture-style from the podium. The abstract author is considered the session chair and will coordinate efforts in recruiting speakers and manage the session. PowerPoint presentations are required. We welcome innovative ideas for session formats that will enhance interaction between stakeholders.

Presentation Abstract
A presentation abstract is for a 20-minute presentation in a specific topic area. The abstract author is considered the speaker and a PowerPoint presentation is required.

Tutorial Abstract
A tutorial is a ‘hands-on’, interactive learning experience. A tutorial consists of three hours of instruction with a 30-minute break halfway through. The abstract author is considered the instructor. One co-instructor may be recruited but cannot be from the same company/organization as the author.

To give your session, presentation or tutorial abstract the best chance of being accepted focus on the programme themes.

Hot-Topic/Stand-Alone Sessions
Each year, there are a number of sessions that do not fit directly under the programme themes. If your abstract clearly does not fit with any of the themes/topics outlined, you may submit it for consideration as a hot-topic/stand-alone presentation/session.





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Monday, April 8, 2013

Health Economic Outcomes/Comparative Effectiveness Research/Health Technology Assessment Track at DIA's 49th Annual Meeting


TRACK 13: HEALTH ECONOMICS AND OUTCOMES (HEO)/COMPARATIVE EFFECTIVENESS RESEARCH (CER)/HEALTH TECHNOLOGY ASSESSMENT (HTA)
Learning Objectives:  Describe current issues in measuring and communicating the medical need, health impact, and economic value associated with medical products

Tuesday, March 26, 2013

Join high-profile global regulators, industry professionals, and academia to discuss current regulatory landscape in Latin America

Latin American Regulatory Conference (LARC) 2013 | May 15-16, 2013 | Bogota, Colombia
Plan your Attendance at LARC 2013
Take a look at this overview of the insightful sessions coming to the Latin American Regulatory Conference (LARC) 2013. Not registered yet? Book your seat before April 12 to save with an early-bird discount!
Join high-profile global regulators, industry professionals, and academia to discuss the current regulatory landscape and its impact on future research and drug development at the event in Bogota, Colombia from May 15-16.
2012 VIDEO HIGHLIGHTS
Watch videos from last year’s Latin American conferences and get a taste of what you can expect from these insightful events in 2013.
IT ONLY TAKES
A FEW MINUTES...
Update your customer profile to ensure that you receive communications tailored to your specific area(s) of interest.
Session Highlights
  • Updates on Regional and Global Convergence with perspectives from Chile, Colombia, Canada, the PAHO and WHO
  • Latin American Agencies Profiles by CIRS: Number of Reviewers, Inspectors, Timeliness, Predictability and Quality of a Full Review
  • Case Study: Challenges faced by Regulators in the Adoption of Internationally Recognized Technical Guidance Documents and Standards
  • Risk Based Approach to Inspections
  • Integrity of the Supply Chain: Serialization, Counterfeits and Disposal of Expired Drugs
  • Transparency of Review Process
  • Health Technology Assessment
  • Implementation of e-Submissions
  • “Miracle” Drugs and Pharmaceutical Products Bordering
    Dietary Supplement
10th Latin American Conference on Clinical Research (2013) | October 20-22, 2013 | Sao Paulo, Brazil
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Tuesday, March 5, 2013

Highlights for upcoming Latin American Regulatory Conference - May 15-16, Bogota

Latin American Regulatory Conference (LARC) 2013 | May 15-16, 2013 | Bogota, Colombia
Check out the Highlights for LARC 2013
Download the program and see what’s in store at the Latin American Regulatory Conference
(LARC) 2013
.
Join global regulators, industry professionals and academia to discuss the current regulatory landscape and its impact on future research and drug development at the event in Bogota, Colombia from May 15-16.
The LARC 2013 will focus on “Pharma-Co-Vergence” – the act of achieving pharmaceutical regulatory convergence through stakeholders’ collaboration – highlighting the true collaborative spirit of this multidisciplinary global conference.
Attendees will learn how to define the various initiatives related to global regulatory environment and their impact on the access of medicines and future R&D in Latin America, and discuss the progress of the Pan American Network for Drug Regulatory Harmonization (PANDRH) convergence process and working groups.
2012 VIDEO HIGHLIGHTS
Watch videos from last year’s Latin American conferences and get a taste of what you can expect from these insightful events in 2013.
IT ONLY TAKES
A FEW MINUTES...
Update your customer profile to ensure that you receive communications tailored to your specific area(s) of interest.
Featured Topics
  • Regulatory Landscape and Convergence Initiatives
  • Strengthening the Regulatory Framework
  • Efforts Underway by Convergence Initiatives
  • Reviews and Inspections
  • Ethics Committee Research in the Regions
  • Post-market Research Studies and Better Medicines
    to Influence
  • Efficacy and Effectiveness
  • Perspectives and Regulations of Pediatric Studies
  • Drug Safety, Marketing Surveillance and Quality Control Monitoring
  • Regulatory Concerns: Health Systems and Security of the Supply Chain
  • Current Regulations of Biologics and Biosimilars
  • Emerging Topics
Who Should Attend
Professionals involved in:
  • Regulatory affairs
  • Clinical research and development
  • Clinical safety and pharmacovigilance
  • Clinical trial and project management
  • Drug development and discovery
  • Medical and scientific affairs
  • Preclinical development
  • Quality assurance
  • Research and development
  • Strategic sourcing/planning
10th Latin American Conference on Clinical Research (2013) | October 20-22, 2013 | Sao Paulo, Brazil
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Friday, February 1, 2013

Professional development - Tutorials at EuroMeeting2013 4 March in Amsterdam


Thursday, January 31, 2013

DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Sciences - Boston, June 23-27

About DIA 2013 DIA 2013 49th Annual Meeting: Advancing Therapeutic Innovation and Regulatory Sciences 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 medical products and therapies to patients.

DIA 2013 49th Annual Meeting 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
  • Offer a holistic and integrated approach to the development and life cycle management of regulated health care products
To that end, DIA 2013 49th Annual Meeting provides the best opportunity to meet with people from around the world, share your views and knowledge, network, and build new relationships.

“A lot is being done to try to advance clinical development to become more efficient, to become more effective, and that the DIA provides an opportunity to share those kinds of ideas.” - Jeffrey McMullen, President and CEO, PharmaNet/i3

“Well, DIA really prides itself on providing a neutral forum. And that aspect of neutrality not only means that our attendees can have more confidence in the content, but it also means we have a lot more diversity of stakeholders presenting.” - Craig Lipset, DIA 2012 Program Chair

“It’s definitely one of the leading meetings that we attend.” - Josef von Rickenbach, Chairman and CEO, PAREXEL International

DIA’s Annual Meeting brings together all the stakeholders to enhance the health and well-being of patients.

HTA/Sustainability of Health Systems in Europe sessons at EuroMeeting2013 - 4-6 March in Amsterdam

Wednesday, January 30, 2013

Session Highlights at EuroMeeting2013 - 4-6 March in Amsterdam


Session Highlights at the EuroMeeting 2013
Among the packed conference programme of the EuroMeeting are a few sessions, that you definitely don't want to miss. Hot topics, presentations delivered by high level speakers, and the opportunity to discuss current issues with fellow professionals and our special presenters.
Opening Plenary: Public/Private Partnerships – Working Together in the Interest of Patients
4 March | 14:00-17:15
Public-private partnerships (PPP) are collaborative relationships that transcend national boundaries. Each partnership brings together at least a corporation or an industry association and intergovernmental organisations to achieve a shared health-creating goal on the basis of a mutually agreed division of tasks. The positive aspects and concerns of these initiatives will be discussed.
Moderator:
Steffen Thirstrup, Head of Division, Medicines Assessment and Clinical Trials, Danish Health and Medicines Authority, Denmark

Panelists:
Jan Geissler, Director, EUPATI, Belgium
Kemal Malik, Head of Global Development, Member of the Bayer HealthCare Executive Committee and Chief Medical Officer, Bayer HealthCare Pharmaceuticals, Germany
Pat O’Mahony, Chief Executive, Irish Medicines Board, Ireland
Luca Pani, Director General, Italian Medicines Agency (AIFA), Italy
Andrzej Rys, Director of Health Systems and Products, European Commission, EU
Harpreet Singh, Managing/CSO, Immamics Biotechnologies, Germany

Sessions 1803/1804: GCP Hot Topics
5 March | 14:00-17:30
Session Chairs
Gabriele Schwarz, Head, GCP Inspection Services, German Federal Institute for Drugs and Medical Devices (BfArM), Germany
Beat Widler, Senior Partner, Widler & Schiemann, Switzerland

The GCP Hot Topics Sessions that in recent editions of the EuroMeeting have been bringing together regulators, industry, CRO and academia professionals who want to get first hand information on newest trends, has by now become a EuroMeeting tradition.

In 2013 the impact of changes and evolutions in technology on the conduct and quality management of clinical trials determine the programme of the GCP Hot Topic session. The focus will be on electronic health records (EHRs) when used as source documents or direct input source into clinical trial databases. As a second topic the session will deal with the challenges presented to sponsors and CROs when clinical trial activities are outsourced. This topic is not new but becomes increasingly a root cause of major and critical inspection findings. The program will be completed by the presentation of the White Paper on protocol violations that has been authored by the GCP SIAC.
As in other years the roster of international speakers will involve senior representatives from health authorities, industry and CROs. The audience is invited to actively participate in the panel discussions by bringing examples or challenging statements. Delegates can anonymously submit topic-related questions or cases they would like to be discussed by the panel in advance to the session chairs via the DIA.

Session 1805: EMA Roundtable – Scientific Committees United in Diversity
6 March | 9:00-10:30

Session Chair: Hans-Georg Eichler, Senior Medical Officer, European Medicines Agency, EU
This roundtable will discuss how the EU Scientific Committees come together and interact at the European Medicines Agency to foster scientific excellence in the evaluation and supervision of medicines for the benefit of public health, while being enriched by the EU’s many different cultures and traditions.

Session 1207: Regulatory Town Hall Meeting
6 March | 14:00-15:30

Session Co-Chairs: Guido Rasi, Executive Director, European Medicines Agency, EU and Christa Wirthumer-Hoche, Member CMDh, Deputy Head, Austrian Medicines and Medical Devices Agency (AGES), Austria.
At the Town Hall Meeting attendees can put burning questions to experts about these topics:
• Latest views on legislative changes
• Implementation of the new pharmacovigilance legislation
• Transparency
• Drug shortages
• Decision making
• New approaches to licensing
Download the full Conference Programme and read about these, and the 110+ other sessions, the exhibition and other activities the EuroMeeting has to offer. If you have any specific questions, please feel free to contact us.
Make the most of your EuroMeeting Experience - register for a Pre-Conference Tutorial
Monday, 4 March | 09:00-12:30

Showcase your company’s products or services to key decision makers
The exhibition hall is one of the busiest places at the meeting and provides a unique opportunity to interact with professionals from more than 50 countries working in pharma, devices, government, academia, healthcare delivery and other related occupations, together with representatives from patient organisations and much more.
Apply for your Exhibition space today!
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