Insights From Canada’s Thought Leaders on Patient’s Voice, Plain Language Labeling Project, Pharmacovigilance

Exclusive Scoop from Canada's Key Thought Leaders       In this edition of the Insider Update you’ll hear insights from Canada’s key industry thought leaders regarding the impact of patient’s voice in the ever changing regulatory environment, the emerging areas of change in Pharmacovigilance in Canada, and what international regulatory cooperation means to key stakeholders in the development and regulation of health products. In addition, we will address the need to provide the patient and the health care professional with increased accessibility to drug information and comprehension of drug labels, plus more.   “Those who are in the pharmaceutical industry and those in the regulatory realm need to acknowledge the patients’ voice and perspective." "New approaches and collaborations are required to keep up with the realities of the pharmaceutical industry today..." Get the Insider Scoop NOW!    Read More Insider Update

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DIA's Annual Canadian Meeting: New Reality/New Frontiers

DIA's Annual Canadian Meeting: New Reality/New Frontiers DIA Members Save $150. Early-bird expires October 7. Collaborate with key stakeholders: boost awareness and deliver value to today’s patient reality driving change in drug development and regulations. At this Annual Meeting, stakeholders from industry, regulatory agencies, academic researchers, patient and patient advocacy groups will have the opportunity to work together to recognize the challenges faced by the industry and regulators in drug development, market access, and regulations in Canada.  Opening Remarks: Kathryn McDade Assistant Deputy Minister of the Health Products and Food Branch Health Canada Plenary Sessions:     • International Regulatory Cooperation            - Trends and Impacts            - Stakeholder Perspective Break Out Sessions:     • Harmonizing in the Post-Approval Pharmacovigilance:       Challenges and Opportunities     • Social Media     • Update on ICH: What You Need to Know     • Research Networks and Translational Medicine     • Support Programs: The Pursuit of Patient Advocacy     • Update on the Legislative and Regulatory Modernization Initiative     • IT Modernization     • Plain Language Labeling in the Regulatory System: Consumer- and       Patient- Centered Information     • Publicly Accessible Registries: What Clinical Trial Information Needs       to be Disclosed?     • Cool Tools in Medical Devices     • Plus More Tutorial Topics:     • The Emerging PV Landscape in Canada     • Trends in Health Canada Inspections Register 3, Get the 4th FREE! Register three individuals from the same company and receive complimentary registration for a fourth! All four individuals must register and prepay at the same time. Table Top Exhibits: Showcase your products and services to key decision makers in Canada. View Application Now.   View Agenda | Overview | Register Now

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Clinical Safety and Pharmacovigilance Track at DIA2013

 

Do you know how to recognize the impact of benefit-risk assessment in safety data?

What are the new international standards and terminologies for reporting to EudraVigilance?

How does Risk Communication differ in US and EU?

What is the likelihood ratio test-based signal detection method for FDA’s AERS database?

What is the EMA doing to improve benefit-risk assessment of medicines?

What are the current challenges in monitoring BP through the different indications and in the different trial phases?

What are differences in legislation for risk management between the US, EU and Japan?

How can coding with MedDRA® improve clinical safety data?

What are recent innovations driving patient-focused approach to benefit-risk in Canada?

What is the relevance and application of drug interaction predictive models to clinical development?

How can I obtain higher-quality narrative information from patients through traditional and new media?

How can I generate metrics for the effectiveness and efficiency of a signal detection program?

How do I use social media, mobile apps and patient support programs for pharma and biotech industries?

What is the ongoing international standardization work on ICSR and IDMP?

What are recommendations from projects of the Clinical Trials Transformation Initiative?

How can I anticipate factors that may increase the incidence of drug shortages in the future?

What are the initiatives using electronic health records for drug safety signal detection and evaluation?

How can Herbal-induced Organ Toxicity impact Rx Benefit-risk?

How do I compile a PSUR according to the new EU and ICH guidance?

What are latest developments in pharmacovigilance in the developing countries of Asia and Latin America?

What are the current methods of tracking misuse and abuse of marketed pharmaceuticals?

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For our friends in China, we kindly suggest the following sessions at #DIA2013 in Boston, MA.

For our friends in China, we kindly suggest the following sessions at this year's annual meeting in Boston, MA.

Global Clinical Trials: The Role of Emerging Markets         
What are the areas of potential risks when undertaking global clinical trials in emerging markets?
Convergence in Regulatory Science Across the Strait
What are areas of convergence in regulatory science between CDE-China and CDE-Taiwan?
GCPs in Emerging Countries
What are the GCP quality trends in US and emerging countries?
Pharmacovigilance Update for Japan, Developing Asia and Latin America
What are latest developments in pharmacovigilance in the developing countries of Asia and Latin America?
A Regulatory Perspective of Biosimilars in Emerging Markets
What are similarities/differences in biosimilar regulatory requirements in APAC and Latin America?

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Do you know how to recognize the impact of benefit-risk assessment in safety data?

Analysis of Safety Data from Clinical Trials
June 23 from 1:00PM – 4:30PM in Boston


This tutorial is designed for RA professionals, epidemiologists, drug safety professionals, medical affairs professionals, pharmacovigilance and quality management professionals, and clinical affairs professionals. The tutorial is a combination of theory, guidelines, practical considerations and real life solutions for those working in the clinical development environment. The aim of this tutorial is to provide a basic understanding of the underlying methodology and the current guidelines on safety data. Aspects of the planning of clinical trials as well as the problems and pitfalls during the analysis of safety data will be presented. The presentations will also include case studies.

Instructor(s):
Joachim Vollmar, MSc
Executive Consultant
International Clinical Development Consultants LLC, United States

Juergen Kuebler, PhD
Global Head, Clinical Design, Analysis, and Reporting
CSL Behring GmbH, Germany

What’s more…Receive $100 off of your DIA 2013 Annual Meeting registration by registering for two half day tutorials or one full day tutorial. Please note purchases must be made at the same time in order to receive the discount.

Visit www.diahome.org/DIA2013 for more details on the DIA 2013 Annual Meeting being held June 23-27 in Boston, MA.

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For our friends in Japan, we kindly suggest the following sessions at #DIA2013 in Boston, MA.

 

For our friends in Japan, we kindly suggest the following sessions at this year's annual meeting in Boston, MA.

Global Clinical Trials: The Role of Emerging Markets         

What are the areas of potential risks when undertaking global clinical trials in emerging markets?
GCPs in Emerging Countries
What are the GCP quality trends in US and emerging countries?

Risk Management in the US, EU and Japan: The Challenges of Diversity

What are differences in legislation for risk management between the US, EU and Japan?
Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall
PMDA Town Hall: Japanese regulation activities and initiatives

Challenges for Stable Supply of Drugs and International Cooperation

What is the current drug supply situation in US, EU and Japan?

Pharmacovigilance Update for Japan, Developing Asia and Latin America

What are latest developments in pharmacovigilance in the developing countries of Asia and Latin America?

A Regulatory Perspective of Biosimilars in Emerging Markets

What are similarities/differences in Biosimilar regulatory requirements in APAC and Latin America?


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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.

Find Out More | Submit Your Abstract

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Webinars: Important Updates on New European Pharmacovigilance Requirements

Important Updates on New European Pharmacovigilance Requirements Two-Part Webinar Series: Impact of the New European Pharmacovigilance Legislation and Important Updates April 25-26 | 10:00-11:30AM ET Presenters:     • Stella C.F. Blackburn, MD, MA, MSc, FFPM, FISPE, FRCP        EMA Risk Management Development and Scientific Lead, European Medicines Agency     • Joanna Faith Haas, MD, MSc, FACPM, FISPE, Founding Partner, Haas and Partners     • Steve Jolley, MA, Principal, SJ Pharma Consulting With the new European Pharmacovigilance legislation that went into effect in July 2012, implementation is ongoing. Hear from global experts on the impact of the new Pharmacovigilance legislation and important updates since the legislation went into effect. Does your company understand the processes to perform adequate Benefit-risk assessment? Your product could suffer significant consequences if your company does not have the proper systems and processes in place. In just two 90-minute sessions you will gain a better understanding of how to work to meet EU standards and become better prepared to implement regulatory requirements for signaling and risk management. Featured Topics:     Part One:     • EU Regulatory Framework     • Ongoing Timeframe for Implementation of the New Legislation     • GVP Modules and Implementing Measures     • PV System Master File (PSMF)     • Audit and Inspection     • ADR Reporting     • The Pharmacovigilance Risk Assessment Committee (PRAC)     Part Two:     • Risk Management Plans: Risk Assessment and Risk Minimization     • Periodic Safety Update Reports (PSUR)/ Periodic Benefit-risk Evaluation Report (PBRER)     • Signal Management     • Post Authorization Studies of Safety (PASS) and Efficacy (PAES)     • Implications for International Harmonization     • And More... You’ll Learn:     • New EU regulatory requirements for drug safety     • How to process adverse events to meet EU requirements     • What to expect in a European Pharmacovigilance inspection     • Differences between the old PSUR and the new PBRER This is the webinar your entire Pharmacovigilance team cannot afford to miss. Who Should Attend? Professionals involved in:      • Drug Safety and Pharmacovigilance      • Regulatory Affairs      • Clinical Development      • Benefit-risk Management • Executives (Including C-Level) with Any Legal    Responsibility for Drug Safety • Market Access • Post-approval Studies Did You Know? You can receive 1 elective unit towards your Clinical Safety and Pharmacovigilance Certificate by attending this webinar.   Overview | Register Online April 18 | 11:00AM-12:30PM ET April 24 | 11:00AM-12:30PM ET April 30 | 12:30-2:00PM ET

Sign up for DIA's Global SmartBrief: Break through the information clutter with FREE, twice-weekly email publication that gives quick, easy-to-read summaries of articles relevant to you. Get the latest news in drug development innovations worldwide wherever you are on your laptop or smart phone with SmartBrief’s wireless compatibility.

What's on tap for final day of EuroMeeting2013? March 6, Amsterdam

EuroMeeting2013
RAI
Amsterdam

Final day: Wednesday, Mar, 06 (51)

• Title: FOCUS ON MANAGED ENTRY AGREEMENTS (AND REAL WORLD DATA)
  Event Type: SESSION
  Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: HOW TO OPTIMISE CLINICAL DEVELOPMENT IN THE ELDERLY: SOME PRACTICAL EXAMPLES
  Event Type: SESSION
  Tracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: FROM VOLUNTARY HARMONISATION TO CLINICAL TRIAL REGULATION L TRIALS
  Event Type: SESSION
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: NEW OPPORTUNITIES FOR INFORMATION TECHNOLOGY IN PHARMACOVIGILANCE
  Event Type: SESSION
  Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: QUALITY UPDATE - CURRENT DEVELOPMENTS
  Event Type: SESSION
  Tracks: Theme 06 - Quality (including Falsified Medicines) Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: LATEST US REGULATORY MOVES TOWARDS FOSTERING INNOVATION: UPDATE ON MAIN NEW AND REVISED REGULATIONS AND GUIDANCE
  Event Type: SESSION
  Tracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: KNOWN ACTIVE SUBSTANCES FOR THE SELF-CARE SECTOR
  Event Type: SESSION
  Tracks: Theme 10 - Known Active Substances Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: INNOVATIVE APPROACHES TO PRODUCT INFORMATION FOR PHYSICIANS AND PATIENTS
  Event Type: SESSION
  Tracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work? Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: MNC’S EXPANSION IN EMERGING MARKETS: OPPORTUNITIES AND CHALLENGES
  Event Type: SESSION
  Tracks: Theme 13 - Globalisation Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: A CASE STUDY USING THE FRAMEWORK SUPPORTED BY QUANTATATIVE METHODS FOR BENEFIT/RISK ASSESSMENT
  Event Type: SESSION
  Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: NON-CLINICAL TESTING FOR ADVANCED THERAPY
  Event Type: SESSION
  Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: FOCUS ON MEDICINES EFFICACY, SAFETY AND USAGE IN EDUCATION AND TRAINING
  Event Type: SESSION
  Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: EMA ROUNDTABLE- SCIENTIFIC COMMITTEES UNITED IN DIVERSITY
  Event Type: SESSION
  Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: SOCIAL MEDIA/USE OF TABLETS AND SMARTPHONES
  Event Type: SESSION
  Tracks: Theme 08 - eTools and Data Management Day: Wednesday, Mar, 06
  Time: 9:00AM - 10:30AM
• Title: THE IMPACT OF THE NEW PHARMACOVIGILANCE LEGISLATION INSTRUMENTS ON HTAS
  Event Type: SESSION
  Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: PAEDIATRIC CLINICAL TRIALS – TRIAL BY DESIGN
  Event Type: SESSION
  Tracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: TRANSPARENCY ON DOSSIER AND DECISION MAKING – HAS PUBLIC TRUST INCREASED?
  Event Type: SESSION
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: RISK COMMUNICATION AND TRANSPARENCY
  Event Type: SESSION
  Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: ADOPTION OF GAME CHANGING TECHNOLOGIES
  Event Type: SESSION
  Tracks: Theme 05 - Clinical Research and Development Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: INTERNATIONAL HARMONISATION: GLOBAL REGULATORS’ PROGRESS FROM GHTF TO IMDRF - ARE WE ANY NEARER TO REGULATORY CONVERGENCE?
  Event Type: SESSION
  Tracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: ATTRIBUTING SAFETY REPORTS TO MEDICINAL PRODUCTS
  Event Type: SESSION
  Tracks: Theme 08 - eTools and Data Management Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: BIOSIMILARS: DEVELOPING A MORE THOROUGH UNDERSTANDING OF A KNOWN ACTIVE SUBSTANCE
  Event Type: SESSION
  Tracks: Theme 10 - Known Active Substances Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: ENVIRONMENTAL CONSIDERATIONS IN PRODUCTION OF MEDICINAL PRODUCTS
  Event Type: SESSION
  Tracks: Theme 13 - Globalisation Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: EQUIVALENCE OF ORALLY INHALED PRODUCTS
  Event Type: SESSION
  Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: NEW TRENDS IN INVITRO NON-CLINICAL TESTING
  Event Type: SESSION
  Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: QUALITY CAREER DEVELOPMENT IN GLOBAL MEDICINES DEVELOPMENT
  Event Type: SESSION
  Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: JAPANESE REGULATORY SESSION – PMDA UPDATE
  Event Type: SESSION
  Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: QUALITY RISK MANAGEMENT WORKSHOP
  Event Type: WORKSHOP
  Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
  Time: 11:00AM - 12:30PM
• Title: THE PATIENTS’ PERSPECTIVE ON HTA
  Event Type: SESSION
  Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: LEGAL AND PRACTICAL ASPECTS OF OFF-LABEL USE
  Event Type: SESSION
  Tracks: Theme 03 - Legal/Transparency-Risk Assessment Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: IMPACT OF ICH E2C (R2) AND GVP MODULE VII
  Event Type: SESSION
  Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: PATIENT RECRUITMENT AND RETENTION
  Event Type: SESSION
  Tracks: Theme 05 - Clinical Research and Development Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: PHARMACOPOEIAL HARMONISATION- A NEVER ENDING STORY
  Event Type: SESSION
  Tracks: Theme 06 - Quality (including Falsified Medicines) Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: HOW SYNERGY BETWEEN DATA MANAGEMENT AND TECHNOLOGY WILL DRIVE CLINICAL DEVELOPMENT IN THE NEXT DECADE
  Event Type: SESSION
  Tracks: Theme 08 - eTools and Data Management Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: COMBINATION MEDICINAL DRUG PRODUCTS OF KNOWN ACTIVE SUBSTANCES
  Event Type: SESSION
  Tracks: Theme 10 - Known Active Substances Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: REGULATORY TOWN HALL MEETING
  Event Type: SESSION
  Tracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work? Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: SUBGROUP ANALYSES
  Event Type: SESSION
  Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: NEW ICH INITIATIVES IN SAFETY TESTING
  Event Type: SESSION
  Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: EUPATI - THE EUROPEAN PATIENTS ACADEMY ON THERAPEUTIC INNOVATION – AN UNPRECEDENTED PUBLIC PRIVATE PARTNERSHIP TO EMPOWER PATIENTS TO ENGAGE AS REAL PARTNERS IN THE DRUG DEVELOPMENT PROCESS
  Event Type: SESSION
  Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: ASIAN STRATEGY OF THE USA, EUROPE AND JAPAN
  Event Type: SESSION
  Tracks: Theme 13 - Globalisation Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: PERSPECTIVES AND COLLABORATION BETWEEN PATIENTS AND STUDENTS
  Event Type: SESSION
  Tracks: Theme 18 - Stand-Alone Sessions Day: Wednesday, Mar, 06
  Time: 2:00PM - 3:30PM
• Title: HTA AND OFF-LABEL USE
  Event Type: SESSION
  Tracks: Theme 01 - HTA/Sustainability of Health Systems in Europe Day: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM
• Title: PAEDIATRIC REQUIREMENTS – DO THEY DELIVER AND AT WHICH COST?
  Event Type: SESSION
  Tracks: Theme 02 - Development of Medicinal Products for Paediatric, Elderly and other Day: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM
• Title: DEVELOPMENT OF PHARMACOVIGILANCE METHODOLOGY
  Event Type: SESSION
  Tracks: Theme 04 - Pharmacovigilance Day: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM
• Title: COLLECTING RELEVANT HEALTH OUTCOME DATA
  Event Type: SESSION
  Tracks: Theme 05 - Clinical Research and Development Day: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM
• Title: HARMONISATION – PITFALLS AND HOW CAN WE SPEED IT UP?
  Event Type: SESSION
  Tracks: Theme 06 - Quality (including Falsified Medicines) Day: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM
• Title: WHICH EU REGULATORY RULES FOR TELEMEDICINE, EHEALTH AND MHEALTH? HOW CAN INNOVATION BE ENCOURAGED?
  Event Type: SESSION
  Tracks: Theme 07 - Devices & In Vitro Diagnostics and Drug/Device Combination Products Day: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM
• Title: CLINICAL TRIALS IN EUROPE: WILL THE REVISED LEGISLATION MEET THE DEMANDS OF TOMORROW?
  Event Type: SESSION
  Tracks: Theme 12 - Effectiveness and Efficiency in the EU Regulatory system - Does new legislation work? Day: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM
• Title: STATISTICAL HOT TOPICS IN SCIENTIFIC ADVICE
  Event Type: SESSION
  Tracks: Theme 15 - Growing Demand for Quantitative Approaches in Drug Development Day: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM
• Title: OVERVIEW OF CURRENT DISCUSSIONS IN ICH
  Event Type: SESSION
  Tracks: Theme 16 - Non-Clinical Day: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM
• Title: TOWARDS A EUROPEAN FRAMEWORK FOR CONTINUING PROFESSIONAL DEVELOPMENT IN A LIFE-LONG LEARNING PERSPECTIVE
  Event Type: SESSION
  Tracks: Theme 17 - IMI Public-Private Partnership in Medicines Research Education and Training – for Professionals and for Patients Day: Wednesday, Mar, 06
  Time: 4:00PM - 5:30PM