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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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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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

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The 4th Pharmacovigilance Conference in India is now only three days away.

Don’t Miss Your Chance to Exchange Knowledge The 4th Pharmacovigilance Conference in India is now only three days away. Take this opportunity to discuss the latest global challenges in drug safety with professionals worldwide. Professionals attending the two-day conference, to be held in Bangalore from March 8-9, will 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. Read More View Program Register EXHIBITING OPPORTUNITY Download the application for a tabletop display at the event. Other events of Interest Download the India Calendar of Events Conference Highlights Updates on recently released GPvP Modules by EMA Japanese model of EPPV – a way forward for other Asian countries Challenges in authoring PSUR for generic manufacturers An insight into Drug Induced Liver Injury (DILI) Global regulatory compliance: challenges and the way forward Safety regulations in emerging Middle East region Efficient management of literature searching Enhanced productivity and quality through process re-engineering; case studies Global outsourcing trends in PV – Indian potential and challenges by China, Taiwan, and Latin America RSI management – best practices to safeguard against pitfalls Attrition and manpower stability; KPO perspective Technology-watch against safety hazard of spurious and adulterated drugs Training; A Formality or a Reality – an industry insight Panel discussion: compensation for trial related injuries This Pharmacovigilance Conference is perfect for professionals with experience in clinical safety and who are involved in: Pharmacovigilance Clinical research Risk management Compliance Medical information Regulatory affairs Academia Pharmacology Read More View Program Register To know more, contact Manoj.Trivedi@diaindia.org Thank You to our Media Partner

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Show what your company has to offer at 4th Pharmacovigilance Conference in Bangalore

Show what your company has to offer Showcase you company’s product or service and network with industry professionals at the 4th Pharmacovigilance Conference in India. The two-day conference, to be held in Bangalore from March 8-9, brings together pharmacovigilance, clinical research, medical information, and regulatory professionals and academia to discuss the latest global challenges in drug safety. Your company can exhibit with a tabletop display and receive one complimentary full-meeting registration and one exhibit personnel registration. Or become a Platinum Level Supporter and receive three complimentary full-meeting registrations, three exhibit personnel registrations, and exclusive branding and promotion opportunities. Click here for further details and apply today. View Program Download Application Other events of Interest Download the India Calendar of Events Conference Highlights Updates on recently released GPvP Modules by EMA Japanese model of EPPV – a way forward for other Asian countries Challenges in authoring PSUR for generic manufacturers An insight into Drug Induced Liver Injury (DILI) Global regulatory compliance: challenges and the way forward Safety regulations in emerging Middle East region Efficient management of literature searching Enhanced productivity and quality through process re-engineering; case studies Global outsourcing trends in PV – Indian potential and challenges by China, Taiwan, and Latin America RSI management – best practices to safeguard against pitfalls Attrition and manpower stability; KPO perspective Technology-watch against safety hazard of spurious and adulterated drugs Training; A Formality or a Reality – an industry insight Panel discussion: compensation for trial related injuries This Pharmacovigilance Conference is perfect for professionals with experience in clinical safety and who are involved in: Pharmacovigilance Clinical research Risk management Compliance Medical information Regulatory affairs Academia Pharmacology Read More View Program Register To know more, contact Manoj.Trivedi@diaindia.org Thank You to our Media Partner

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