What is the appropriate response to FDA enforcement?

FDA Enforcement: Understanding the Agency's Authority, How Violations Occur, How to Prevent Them and How to Respond if Violations Do Occur
June 23 from 8:30AM – 12:00PM in Boston

This tutorial is designed for all personnel responsible for ensuring compliance with FDA requirements, particularly those under the GMP and GCP rules, regardless of whether in a supervisory or direct role. This tutorial will review and discuss the legal, regulatory, and practical challenges of (1) FDA enforcement priorities for 2013 and beyond; (2) FDA administrative enforcement weapons and how the Agency uses them; and (3) the civil and criminal penalties for violations. Interactive discussions will focus on how FDA operates and makes decisions and how to respond effectively, using tactics ranging from negotiation to, when appropriate, litigation.

Instructor:
Michael A. Swit, JD
Special Counsel
Duane Morris, LLP, United States

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.

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

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?

Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

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?


Sign up for DIA's Global SmartBrief eNews for the latest in drug development innovations worldwide.

Clinical Operations Track at DIA's 49th Annual Meeting

 

• What are the emerging challenges with patient registries? 
• What do you need to know about statistics?  Variability~confidence intervals~hypothesis testing~p-values
• What are the best practices in patient recruitment, budgets and contracts, and FDA audit readiness?
• How do you ensure data integrity with reduced expenditures on traditional 100% on-site monitoring and SDV?
• How do different enrollment metrics/analyses benefit different stakeholders (site/sponsor/recruiter)? 
• Do you know how to shape your cost with hard and soft coverage analysis trends?
• How can investigator sites pave the way for running successful Clinical Trials?
• Is this trial worth it? Finding answers for Site and Project Managers.
• How should you tailor existing patient recruitment programs to engage parents for Pediatric Trials?  
• How do you establish metrics for Optimal Patient Recruitment and Retention?  
• What global requirements are needed in the Informed Consent Process? 
• What are the Domestic and Global trends in Clinical Trial budgeting?  
• How can we use Big Data to design smarter clinical studies? 
• Can a mathematical algorithm used in point-of-care risk assessment id and screen Clinical Trial subjects?  
• How do you build Patient engagement to make Clinical Research better for everyone?  
• Learn to apply innovation, avoid controversy and implement best practices in Clinical Trials 
• How can site metrics be used to improve enrollment timelines?
• Can you identify Pharmacy-directed outreach and Patient  Recruitment strategies for your Clinical Trial? 
• What do you need to maintain regulatory compliance with continuously evolving import/export processes? 
• How do you solve key challenges to running efficient investigator meetings during Clinical Study startup? 
• What impact will FDASIA have on your need to recruit diverse clinical subjects?  
• What 4 pillars support comprehensive operational feasibility assessment for Clinical Trial planning?  
• Fed Up with tracking pointless Metrics? Learn how to select and use Metrics that work.  
• What are the challenges and requirements of implementing Central Statistical Monitoring? 
• What unique challenges are associated with pediatric trial recruitment, retention and blood sample collection?  
• What are the Diverse Operational Approaches to generating evidence in the Late-phase Environment? 
• What are the areas of potential risks when undertaking Global Clinical Trials in Emerging Markets? 

FDA proposes more consistent clinical data requirements

By Stewart Eisenhart, Emergo Group

The US Food and Drug Administration has published a proposed rule that would require medical device clinical studies conducted outside the US in order to support product registrations to be conducted in compliance with Good Clinical Practice (GCP). Part of GCP requires manufacturers using overseas clinical studies in their US registration applications to show proof of review and approval of their studies by Independent Ethics Committees (IEC).

Through the proposed rule, the FDA is seeking to establish consistent clinical data acceptance requirements across all types of medical device applications and submissions, as well as take into account evolving Good Clinical Practice principles.

for complete article, http://www.massdevice.com/blogs/massdevice/fda-proposes-more-consistent-clinical-data-requirements

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 | 14:00-17:15Public-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 Read more... Download Advance Programme Register now Exhibiting Opportunities at the 25th Annual EuroMeeting 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! More information... Download Application Form.... Exhibitor Prospectus Marketing & Hosting Information

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FDA Enforcement: Understanding the Agency's Authority


Preconference Tutorial designed for all personnel responsible for ensuring compliance with FDA requirements, particularly those under the GMP and GCP rules, regardless of whether in a supervisory or direct role.

#21: FDA Enforcement:Understanding the Agency's Authority, How Violations Occur, How to PreventThem, and How to Respond If Violations Do Occur

Day & Time:June 24, 8:30AM - 12:00PM - Philadelphia, PA

This tutorial will review and discuss the legal, regulatory, and practical challenges of (1) FDA enforcement priorities for 2012 and beyond (e.g., application integrity policy and GMP/GCP requirements), (2) FDA administrative enforcement weapons and how the Agency uses them (e.g., inspections, warning letters, publicity, recalls, and investigator disqualification proceedings), and (3) the civil and criminal penalties for violations (e.g., seizure, injunction, criminal prosecution). Included in our focus will be FDA's renewed commitment to enforcement as articulated in an August 2009 speech by Commissioner Margaret Hamburg. We also will address how to handle an FDA enforcement action should you face one, particularly in the wake of an inspection or Warning Letter and the impact of the new initiatives related to responding to 483s and Warning Letters implemented in 2009 following Commissioner's Hamburg's pledge to boost enforcement. These interactive discussions will focus on how FDA operates and makes decisions and how to respond effectively, using tactics ranging from negotiation to, when appropriate, litigation.

see link for special offers and more details:

http://www.diahome.org/en/flagship-meetings/dia2012/Meeting-Program/About-our-Offerings/Find-Sessions-and-Presentations/Event%20Details.aspx?productID=28301&eventType=TUTORIAL&title=#21: FDA Enforcement: Understanding the Agency