Description: Legal authority Darshan Kulkarni outlines a strategy for springing into fast action with an inspection “war room” that can address any issue. Kulkarni covers:

• Roles and responsibilities for personnel involved in inspections;
• How to greet inspectors and assemble the war room team; and
• When to call on outside experts for help.

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Speaker: Dr. Darshan Kulkarni, Principal Attorney, Kulkarni Law Firm

Description: A well-rounded team of experts demonstrates why flawed adverse event reporting and labeling have contributed to a suicide epidemic worldwide, putting patients and pharmaceutical companies at increased risk. After offering an overview of the current landscape and weaknesses in key programs, the team provides potential solutions, including:

• Intervention trials using prospective and systematic measurement of suicidality that more clearly delineate the relationship between suicidal adverse events and medication treatment;
• Consistent and systematic assessment that provide more meaningful data within a study, as well as across studies, improving pooled analyses;
• Understanding that decreasing false positives and debunking false notions of risk are as important as knowing about risks that exist; and
• Including suicidal subjects in trials to increase generalizability and avoid unnecessary exclusions.

Presentation #1: Download the presentation from Dr. Kelly Posner

Presentation #2: Download the presentation from Dr. John Greist

Speakers: Dr. Kelly Posner, Founder, Center for Suicide Risk Assessment at Columbia University/New York State Psychiatric Institute; Dr. John Greist, CEO, Healthcare Technology Systems and Mike Federico, Vice President, ePRO solutions, ERT Inc.

Description: Informed consent consultants Susan Brink and Sherry Bracy elucidate the benefits of electronic informed consent programs and offer an insider’s vendor evaluation process, including the answers firms should look for. Questions to ask include:

• How is system access controlled?
• Is there a robust back-up process?
• What is the process for sites if the system is down or the Internet is not available at the time you are obtaining consent from a patient?

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Speakers: Dr. Susan Brink, President and CEO, Consent Solutions Inc. and Sherri Bracy, Founder and Director, Bracy Consulting LLC.

Description: Expert David Vogel outlines FDA recall enforcement trends, and the most common shortcomings in device company recall programs. He also spotlights some less obvious device company recall program weaknesses, including:

• Why large software modules more likely to fail;
• How to assess the amount,  quality of testing;
• How to assess the skill and experience level of a designer – when to put the best designers on the most critical software; and
• How to assess the skill and experience level of testers.

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Speaker: Dr. David Vogel, Founder, Intertech Engineering Associates

Description: Industry expert Brian Dense assesses the strengths and weaknesses of off-the-shelf quality systems against custom solutions, providing real-world case studies that highlight the best and worst of each approach. He also focuses on avoiding several common errors when choosing the best approach, including:

• Misunderstanding the purpose of a quality system;
• Misunderstanding regulatory requirements of the market; and
• Failing to understand that quality is a department, not an integrated practice.

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Speaker: Brian Dense, President, CiNQ Systems

Description: SOP analysts Steven Steinbrueck and Elizabeth Bodi share ways to shorten and focus SOPs, demonstrating how to spot and prevent common mistakes, including:

• Dictating how to accomplish a task;
• Mandating dates; and
• Including things that are not regulatory requirements/expectations, senior management mandates or accepted best practices.

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Speakers: Steven Steinbrueck, President, Stonebridge GCP Consulting and Elizabeth Bodi, Clinical Research Senior Consultant, Halloran Consulting Group

Description: Industry analyst Thomas Peither covers important ground on the many changes to EMA drug process validation. Peither discusses:

• Why validation should be carried out in accordance with GMP;
• The need for a minimum of 3 validation batches; and
• Basing the number of batches on the variability of the process, the complexity of the process/product, and the experience of the manufacturer

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Handout #1: Synopsis: FDA Process Validation Guidance

Handout #2: Guidance for Industry, Process Validation: General Principles and Practices

Handout #3: Note for Guidance on Process Validation

Handout #4: European Medicines Agency: Draft Guideline on Process Validation

Handout #5: Comparison Between EMA and FDA On Traditional Process Validation Approaches

Speaker: Thomas Peither, President, Maas & Peither America Inc.

Description: Noted expert and former FDA official Steven Niedelman is joined by legal analyst Pamela Forrest  to provide detailed insight on the 2012 MDUFA reauthorization, device user fees, FDA performance goals, and other key provisions affecting medical devices, including:

• Conflict of interest scenarios;
• Patient participation in product discussions; and
• Nanotechnology issues.

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Speakers: Steven Niedelman, Lead Quality Systems and Compliance Consultant to the FDA & Life Sciences practice team, King & Spalding and Pamela Furman Forrest, Partner, King & Spalding

Description: An expert legal team maps the complex PDUFA V requirements. Topics covered include;

• The path to market provisions;
• Distribution and supply provisions;
• User fees and performance goals.

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Speakers: Peter Barton Hutt, Senior Counsel, Covington & Burling; Erika Lietzan, Partner, Covington & Burling; Scott Cunningham, Partner, Covington & Burling and Stefanie Doebler, Special Counsel, Covington & Burling

Description: On July 3, 2012, the FDA released a proposed rule on the unique device identification (UDI) system, ending a year-long delay in finalizing the much-anticipated safety mechanism. The 165-page comprehensive rule touches all aspects of the medical device industry. The FDA maintains that the UDI system helps reduce the rate of death caused by faulty devices, which the agency estimates at 17,700 over the past five years. Jeffery Shuren, director of CDRH, called the UDI rule "a major game-changer." The FDA receives numerous device-related adverse event reports, but often can't tell what device the patient is referencing. UDI makes aggregating reports easier, but at what time and cost to industry? Across the board — from supplier, provider, distributor, to consumer — who is ready? Listeners will learn what's hidden in the rule's 165 pages and where to start the journey to implementation. Siobhan O'Bara and John Roberts of GS1 will provide clarification on creating a mandatory system of unique device identifiers.

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Speakers: Siobhan O'Bara, Healthcare Vice President, GS1 US and John Roberts, Director of Healthcare, GS1 US