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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Cooperation Among Regulators: Impact on Stakeholders

Hear Firsthand from FDA Commissioner Hamburg, EMA Executive Director Rasi, and Health Canada Assistant Deputy Minister Glover             View Commissioner Hamburg at Last Year's Annual Meeting Cooperation Among Regulators: Impact on Stakeholders Monday, June 24 Hear views on important issues from the leaders of three of the most influential drug regulatory agencies: The Health Products and Food Branch of Health Canada, the European Medicines Agency, and the U.S. Food and Drug Administration. Join the regulators as they discuss current actions in public policy resulting from interagency actions and strategic communication. Speakers: Chairpersons: Paul Glover, MBA Assistant Deputy Minister of the Health Products and Food Branch Health Canada Marie Allison Dray, MA, MBA President International Regulatory Affairs Group LLC Margaret A. Hamburg, MD Commissioner, FDA  Murray M. Lumpkin, MD, MSc Commissioner's Senior Advisor and Representative for Global Issues, OC, FDA Guido Rasi, MD Executive Director European Medicines Agency European Union Late Breaker Sessions Collaborating to Streamline Drug Development: Are We Making Progress? Wednesday, June 26 In this forum, leaders of two of the best known initiatives – TransCelerate Biopharma Inc (TransCelerate) and the Clinical Trials Transformation Initiative (CTTI) – will provide a status report on current projects, with additional perspectives provided by representatives of the FDA, CROs, and research sites. TransCelerate’s Collaborative Approach to Risk-based Monitoring: The Methodology Wednesday, June 26 TransCelerate BioPharma Inc. (TransCelerate) developed a methodology for monitoring that shifts monitoring processes from an excessive concentration on source data verification to comprehensive risk-driven monitoring. This philosophical shift in monitoring processes employs centralized and offsite mechanisms to identify and monitor important study parameters holistically and uses adaptive onsite monitoring to further support subject safety and data quality. White Paper Showcase features the following two opportunities... Stay Tuned, More to Come! Next Generation Medical Information Call Center Tuesday, June 25 This session will discuss best practices for building a next generation medical information call center that expediently and efficiently delivers medical information on a global scale. We will discuss how advanced technology can enable and enhance critical patient and provider relationships.   Learning to Share-Sharing To Learn: How an Industry Learns to Honor it’s Volunteers Monday, June 24 This session will discuss the potential value of data sharing initiatives and what hurdles need to addressed to successfully create one. Learn what components are needed and how best to support or participate in this next step in the evolution of clinical research.   Coming Soon! Innovation Theater Schedule to be Announced - Stay Tuned!   Overview | Agenda | Register Online Keynote Speaker Preconference Tutorials Hotel & Travel Exhibiting Daniel Kraft, MD Executive Director, FutureMed Register for 2 half-day or 1 full-day tutorial, save $100 on your registration Book within the DIA Room Block, get special perks! 90% of the hall is SOLD. Reserve your booth today!

EuroMeeting Globalisation Track: International collaboration in the review of Generic Drugs

Chair(s):Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium

Description:
With the globalisation trend, an increasing number of generic medicines manufacturers are keen to introduce their products at global scale. For health authorities, a need for fast supply of medicinal products from other markets may occur in case of unexpected shortages in their region. Single development program and more harmonised assessments of generic medicinal products between various markets in order to avoid unnecessary duplications of effort shall be discussed among the authorities and industry.

Presentation(s) & Speaker(s):
Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- EGA proposal
Beata Stepniewska, MPharm
Director of Regulatory Affairs
European Generics Medicines Association EGA, Belgium

Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- View of the CMDh
Peter Bachmann, DrSc
Senior Expert; Chair, Coordination Group for Mutual Recognition and Decentralise
Federal Institute for Drugs and Medical Devices, Germany

Single Development Programme and More Harmonised Assessments of Generic Medicinal Products- Health Canada perspective
Mike D. Ward
Manager, International Programs Division
Health Canada, Canada

for more Globalisation track sessions see Theme 13...

Regulatory Collaboration / 21st Century Innovation - Global Regulatory Affairs at DIA2012

As the premier life science and regulatory affairs event this year, DIA 2012 48th Annual Meeting brings together life science leaders from industry, academia, regulatory agencies, and patient organizations from around the globe. Our June 25th session on Regulatory Collaboration/21st Century Innovation will feature the heads of the leading regulatory agencies – FDA, EMA and Health Canada. This new session was created as a result of feedback from senior regulators and regulatory executives to DIA’s Strategic Planning Committee (of the Board of Directors). You asked for high-level sessions where senior regulatory executives and leading agency regulators might have candid dialogue about current topics affecting global product development and regulation. After brief introductory comments from each Head of Agency, the session will be opened to your questions. You will have the opportunity to ask how these leaders are directing their agencies in international communication with each other on public health and application-specific matters. We would like to invite you to save some time in your busy schedule to attend this session which is scheduled for Monday, June 25th from 1:30-3:00 PM during the first full day of the Annual Meeting. Philadelphia’s central location should make it relatively easy for you to meet with your peers and senior regulators at this DIA session. Click here for the details about this session: Regulatory Collaboration/21st Century Innovation Some other features of the conference in which you might be interested include: Tutorial: Understanding and Navigating the Regulatory System in China This tutorial will provide an overview of the regulatory system in China, including the agencies and institutions at the central government and provincial levels. Regulations for product registration, clinical trials, and safety reporting will be presented, and the regulatory pathways and strategic considerations for clinical trial and marketing applications will be discussed. A roadmap of how to navigate the regulatory system in China for clinical trial approval and product registration will also be discussed. Global Regulatory Track CDER Town Hall: Part 1 and Part 2 CBER Town Hall European Town Hall: Part 1 and Part 2 India Town Hall International Regulatory Cooperation: A Canadian Perspective Latin America Town Hall Pediatric Drug Development Progress: 15 Years Later and Across the Globe Pharmaceuticals and Medical Devices Agency (PMDA) Town Hall SFDA Town Hall Discussion with Former Center for Devices and Radiological Health (CDRH) Management Environment for Health Care Decision Making: The Role of CER, Evidence-based Medicine, Quality, and Value The Role of CER, Evidence-based Medicine, Quality, and Value All non-government professionals can take advantage of one-day rates, while full-time government attendees will receive discounted rates for the full meeting.      Register