Speak at the Clinical Forum 2013 - Submit an Abstract – Deadline Thursday, 4 April 2013

Event Title: 7th Annual Clinical Forum       

Meeting Date:
10/8/2013 9:00:00 AM - 10/9/2013 5:30:00 PM

Location:
The Convention Centre Dublin, CCD Spencer Dock North Wall Quay Dublin 1 Ireland       

Overview:
The DIA Clinical Forum is widely recognised as the only European conference that brings together industry thought leaders across the key disciplines of data management, clinical operations, drug safety and medical communications. This affords delegates the opportunity to network with professional colleagues from all disciplines and from more than 20 countries. You will meet professionals from the pharmaceutical and biotech industries, professionals from academia, CROs, clinical trial sites, health regulatory agencies and delegates from patient organisations.

Target Audience:

Professionals at all levels in the following disciplines:

• Clinical data management
• eClinical
• Clinical research
• Clinical operations
• Post-marketing development
• Clinical safety and pharmacovigilance
• Personal development
• Validation
• Quality assurance
• Medical information and communications
• Medical writing
• Patient advocacy

Diagnosis and Management of Drug-Induced Liver Injury training course - Paris, France

Brand New DIA Training Course DIA Europe is proud to announce a recent addition to the training course portfolio: Diagnosis and Management of Drug-Induced Liver Injury (DILI) 19-20 September 2013 | Paris, France This brand new DIA training course is entirely dedicated to Drug-Induced Liver Injury (DILI) and led by a Hepatologist with extensive experience in clinical assessment of DILI, who published ‘RUCAM’ the widely used causality assessment method of DILI.   The medical approach presented in this training course is also based on the conclusions of international consensus meetings on adverse drug reactions and guidelines published by regulatory authorities. Training Course Calendar 2013 DIA’s highly rated instructor-led training courses are designed to inform and educate professionals and experts on critical issues related to pharmaceuticals, biotechnology, and medical products. Courses on more than 50 topics provide professionals from industry, government, and academia with the opportunity to exchange ideas, knowledge, and best practices with peers and expert instructors. Courses offered range from European regulatory affairs to drug development to safety inspection preparation. View the overview of courses on offer in 2013.

Email Preferences | My DIA | Forward to a Friend |

Upcoming DIA Events in Europe, India, Japan and China

From DIA

China   Training Course: Risk-based Manufacture of Pharmaceuticals: Toxicology and Critical Thinking March 9 | Beijing, China Find out how to better manage risk in the manufacture of pharmaceutical products. This one day session will show you how to use risk assessment for decision-making and also for setting health-based limits. Case studies and examples from a wide variety of fields will be used. There will also be a discussion on effective risk communication.   Europe   25th Annual EuroMeeting March 4-6 | Amsterdam, The Netherlands More than 3,000 professionals involved in the development of medicines from more than 50 countries will gather in Amsterdam at EuroMeeting 2013. The event will feature more than 110 sessions, 200 exhibitors and speakers from the European Medicines Agency, the European Commission, the Food and Drug Administration and other regulatory agencies from around the world.   India   4th Pharmacovigilance Conference in India March 8-9 | Bangalore, India Gain useful new insights into the latest global challenges in drug safety, learn about current global safety reporting requirements for prescription and over-the-counter drugs and discuss new, pragmatic approaches to pharmacovigilance. Other key topics will include the regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan, and identifying best practices for quality assurance in post-marketing pharmacovigilance and clinical safety.   6th Regulatory Conference in India April 5-6 | Ahmedabad, Gujarat, India Remaining competitive in the world market despite ever-evolving regulation is the hot topic at the 6th Regulatory Conference in India. The two-day event, entitled ‘India, the Upcoming Economy: Encouraging Enforcement of Regulations’, will bring together the region’s best talent in the pharmaceutical world to understand what the challenges are and how to face them.   Japan   2nd Project Management Training Course in Japan February 20-21 | Tokyo, Japan A fundamental project management training course on pharmaceutical development. Participants will learn essential and logical techniques of communication, risk management and project team management.   3rd Labeling Workshop in Japan March 16 | Tokyo, Japan How do patients respond to medicine labels? Could the safety messages be clearer? Find out through real examples and prescribers’ views at the 3rd Labeling Workshop. The session will also share information on the experiences of pharmaceutical companies, medical institutes and pharmacists. Submit your abstract for Cardiac Safety Workshop   Call for Abstracts 4th Cardiac Safety Workshop in Japan July 11-12, 2013 | Ivy Hall, Tokyo To submit an abstract for the DIA Cardiac Safety Conference please go to the DIA website: Submission Deadline: February 28, 2013 | Author Notification: March 31, 2013.

Upcoming DIA Events in Europe, India, Japan and China

From DIA

Upcoming Events Europe 25th Annual EuroMeeting March 4-6 | Amsterdam, The Netherlands More than 3,000 professionals involved in the development of medicines from more than 50 countries will gather in Amsterdam at EuroMeeting 2013. The event will feature more than 110 sessions, 200 exhibitors and speakers from the European Medicines Agency, the European Commission, the Food and Drug Administration and other regulatory agencies from around the world. India 4th Pharmacovigilance Conference in India March 8-9 | Bangalore, India Gain useful new insights into the latest global challenges in drug safety, learn about current global safety reporting requirements for prescription and over-the-counter drugs and discuss new, pragmatic approaches to pharmacovigilance. Other key topics will include the regulatory agency clinical safety and pharmacovigilance inspection program in the US, Europe, and Japan, and identifying best practices for quality assurance in post-marketing pharmacovigilance and clinical safety. Japan 16th Annual Workshop in Japan for Clinical Data Management: SMART CDM February 7-8 | Tokyo, Japan Focuses on SMART CDM, to teach all attendees, from beginners to experts, to take full advantage of sophisticated technology and information, provide new perspectives on international clinical data management, and create better solutions for smarter CDM. It will also offer opportunities to network with colleagues in global clinical data management. 2nd Project Management Training Course in Japan February 20-21 | Tokyo, Japan A fundamental project management training course on pharmaceutical development. Participants will learn essential and logical techniques of communication, risk management and project team management. 3rd Labeling Workshop in Japan March 16 | Tokyo, Japan How do patients respond to medicine labels? Could the safety messages be clearer? Find out through real examples and prescribers’ views at the 3rd Labeling Workshop. The session will also share information on the experiences of pharmaceutical companies, medical institutes and pharmacists. Submit your abstract for Cardiac Safety Workshop Call for Abstracts 4th Cardiac Safety Workshop in Japan July 11-12, 2013 | Ivy Hall, Tokyo To submit an abstract for the DIA Cardiac Safety Conference please go to the DIA website: Submission Deadline: February 28, 2013 | Author Notification: March 31, 2013. China Training Course: Risk-based Manufacture of Pharmaceuticals: Toxicology and Critical Thinking March 9 | Beijing, China Find out how to better manage risk in the manufacture of pharmaceutical products. This one day session will show you how to use risk assessment for decision-making and also for setting health-based limits. Case studies and examples from a wide variety of fields will be used. There will also be a discussion on effective risk communication.

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

Theme 01 - HTA/Sustainability of Health Systems in Europe (7)

• Title: THE EUROPEAN LANDSCAPE ON HTA - THE EUnetHTA JOINT ACTION
  Event Type: SESSIONDay: Tuesday, Mar, 05
  Time: 11:00AM - 12:30PM
• Title: COMPARATIVE EFFECTIVENESS AS PART OF THE PUBLIC ASSESSMENT REPORT (PAR)
  Event Type: SESSIONDay: Tuesday, Mar, 05
  Time: 2:00PM - 3:30PM
• Title: HTA AND PRICING POLICIES IN EU AFTER THE TRANSPARENCY DIRECTIVE
  Event Type: SESSIONDay: Tuesday, Mar, 05
  Time: 4:00PM - 5:30PM
• Title: FOCUS ON MANAGED ENTRY AGREEMENTS (AND REAL WORLD DATA)
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: THE IMPACT OF THE NEW PHARMACOVIGILANCE LEGISLATION INSTRUMENTS ON HTAS
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: THE PATIENTS’ PERSPECTIVE ON HTA
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: HTA AND OFF-LABEL USE
  Event Type: SESSIONDay: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM

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

25th Annual EuroMeeting - 4-6 March 2013 - Amsterdam

Welcome from the EuroMeeting Co-Chairs

Dear Colleague,

We are delighted to welcome you to the 25th DIA Annual EuroMeeting to be held in Amsterdam, 4-6 March 2013. Amsterdam is the ultimate “small big city” and combines all the advantages of a cosmopolitan capital with a compact, easy-to-navigate size which translates in less time spent in commuting and more time enjoying what the city has to offer.

The city has a rich cultural heritage and 2013 is a year to celebrate important events there. Besides the 400-year anniversary of the Canal Ring, Amsterdam will be celebrating the re-opening of the fully renovated Rijksmuseum, the 125th anniversary of the Concertgebouw (concert hall) and the Royal Concertgebouw Orchestra, the 225th anniversary of Felix Meritis conference and event centre, and the 175th anniversary of Artis Royal Zoo.

With a focus on better public health protection, greater transparency of the processes and the rational use of medicinal products, the proposed areas for discussion for the Euromeeting 2013 are classified into general disciplines including Pharmacovigilance and Regulatory Affairs for medicinal products and medical devices, R&D and Clinical Trials. The scope of the presentations will cover the experience gathered after the implementation of the new Pharmacovigilance legislative framework, as well as from the patients’ and Health Technology Assessment (HTA) perspective. Experts and authorities in the fields will be presenting their considerations for debate.

By 2013, the new Pharmacovigilance Directive will have been in place for almost a year; knowing what still needs to be done - or improved, and most importantly: are we getting what was initially expected? These are some of the key areas that the professionals attending the meeting will be able to learn about and debate. Other important topics to be covered include the Falsified Medicines Directive, the Information to Patients – what is the status? - the role played by scientific societies as experts, and considerations over an ageing population and the potential impact on hospitalisations.

With such an appealing outline of topics, we look forward to fruitful and engaging discussions that serve to improve further our healthcare systems. Join us in Amsterdam, bring your ideas and simply: Enjoy!

Beatriz Vicén Banzo and Peter Bachman

About the EuroMeeting

The DIA’s Annual EuroMeeting is global in scope and attracts well over 3,000 professionals from more than 50 countries. It brings together professionals from the biopharmaceutical industry, contract research and service organisations, academic research centres, regulatory agencies and health ministries as well as delegates from patient organisations. This convergence affords participants the opportunity to network with professional colleagues from around the world.

Highlights

• Speakers from the European Medicines Agency, the European Commission, the FDA and other regulatory agencies from European countries and other regions of the world
• Unparalleled multi-disciplinary networking opportunities
• Student and professional poster sessions
• Active involvement of patient organisations
• Pre-conference tutorials led by expert faculty
• Hot topic sessions
• More than 200 exhibitors on one of the largest exhibition floors in Europe

Meeting Programme

Stakeholders and professionals of healthcare and life sciences innovation will gather from all over the world for the EuroMeeting 2013. You will experience a neutral, global forum for knowledge exchange that fosters innovation to raise the level of health and wellbeing worldwide. It is our vision that the EuroMeeting 2013 offers you a multidisciplinary, relevant and unforgettable learning experience and expands your personal and professional network.

With a focus on better public health protection, greater transparency of the processes and the rational use of medicinal products, the proposed areas for discussion for the Euromeeting 2013 are classified into general disciplines including Pharmacovigilance and Regulatory Affairs for medicinal products and medical devices, R&D and Clinical Trials. The scope of the presentations will cover the experience gathered after the implementation of the new Pharmacovigilance legislative framework, as well as from the patients’ and Health Technology Assessment (HTA) perspective. Experts and authorities in the fields will be presenting their considerations for debate.

The EuroMeeting 2013 transcends borders and boosts international relations by drawing attention to contemporary issues outside Europe such as in the USA, Brazil, China, Japan and India; and focusing on contemporary issues in the interface between those countries and Europe.

Download the Advance Programme [PDF]

Canada, Switzerland Lift Ban On Novartis Flu Vaccines; Italy Still Testing.

Reuters (11/1, Copley) reports that Canada and Switzerland ended their bans on flu vaccines by Novartis. Bans are still in place by Italy, Austria, Germany, Spain and France. Canada and Switzerland said that their own testing concluded there was no safety issue with white particles found in the vaccines. The particles were identified as collections of protein particles.

        Reuters (11/1, Scherer) reports in a separate story that Italy is continuing to review the matter and declared itself "cautiously positive" it would be able to lift the ban soon.

        160,000 Doses Recalled In UK. The Daily Telegraph (UK) (11/1, Smith) reports that UK "regulators have revealed that 160,000 doses of the Novartis vaccine, Agrippal, are being recalled after 'particles' were found in the vials." However, "a spokesman for the Medicines and Healthcare products Regulatory Agency said there was no safety issue and the recall was a precaution." According to officials, "the recall should not affect supplies as there are 17 other flu vaccines available and other manufacturers should be able to cover the shortfall."

 

DIA Daily is a digest of the most important news selected from thousands of sources by the editors of BulletinHealthcare. The presence of content or advertising does not endorse, nor imply endorsement of, any products or services by the Drug Information Association. Neither BulletinHealthcare nor the Drug Information Association is liable for the use of or reliance on any information contained in this briefing.

If you would like more information about, or have a question pertaining to, DIA Membership and its benefits, please email membership@diahome.org. Click here to check your membership status.

Drug Information Association | 800 Enterprise Road, Suite 200 | Horsham, PA 19044

Copyright © 2012 by BulletinHealthcare | 11190 Sunrise Valley Drive, Suite 130 | Reston, VA 20191