Course Description:

Unlike risk management, which involves managing potential and known threats of narrow scope, crisis management involves managing unknown threats during and after their occurrence. A crisis event, if not managed adequately and timely, could negatively affect the status of applications with the FDA, public image, and financial status of the company.

The workshop on crisis management will allow participants to engage in a simulated, real-world crisis scenario that could put a company’s reputation, profitability and future into jeopardy. Participants will immerse themselves in a realistic, virtual crisis situation focused specifically on an issue related to the regulatory management from the perspective of FDA acceptability. This unique workshop will teach first-hand what is involved in developing a crisis communications plan and managing the plan in real-time, taking into account the importance of FDA guidance and interactions; employee, external stakeholder and media communications; quick response time; and reputation management.

When your company is in a crisis situation, you need to quickly move to control the information, evaluate the event, create and execute a game plan, and diligently close the matter. This workshop will be a lot more fun than handling an actual crisis, but it will also get you thinking in a serious way. It contains a collection of practical tips from the trainer’s extensive IND submission experience.

Who will Benefit:

This workshop will be beneficial for the personnel in all FDA-regulated organizations. The following job titles/ positions will benefit from attending this seminar:

  • Supervisors, and lead workers in Regulatory Affairs
  • Project management personnel
  • Senior management executives (CEO, COO, CFO, etc)
  • Manufacturing managers, supervisors & personnel
  • Crisis managers, disaster management and business continuity management personnel
  • People investing in FDA-regulated product development projects

Topic Background:

In addition to most common crisis situations that affect all companies, medical product companies have to deal with issues such as stagnant product pipelines, unplanned regulatory hurdles and unexpected safety issues with marketed products for which most companies do not or cannot plan ahead. Crisis management should be built into the operational practices of all companies, especially those as highly regulated as in the FDA-regulated industry. In dealing with the US FDA, medical and health care product companies routinely encounter crisis events that require careful regulatory strategic planning, diligent execution and persistent follow-up to ensure successful address of the crisis.

Course Outline:

Day One(8:30 AM – 4:30 PM) Day Two(8:30 AM – 3:30 PM)

Registration Process: 8:30 AM - 9:00 AM

Session Start Time: 9:00 AM

9.00 – 10:30 AM: Lecture 1: Types of Crises Specific to the Medical Product Industry

  • Historical overview of FDA regulations
  • Type of crises: Technological, Regulatory and Organizational
  • Perspectives in anticipating and dealing with crisis
  • Managing public and private information dissemination of information
  • Specific issues for FDA related industry
  • Strategic communication planning for good and bad times
  • Impact of FDA decisions on regulatory decisions in ROW

10:30 – 10:45 AM: Break

10:45 – 12:30 noon: Lecture 2: Changing Trends in Drug Discovery Research

  • Issues with research grade material used for laboratory and non-clinical testing
  • GLP and non-GLP data to support an IND
  • GMP and non-GMP issues to support INDs at different stages
  • Managing and utilizing intellectual property for development and IND/IDEs
  • Assessing IND readiness and FDA acceptability of an IND
  • Assessing need for clinical trials for non-prescription products such as HCTs

12:30 – 1.30 PM: Lunch

1:30 – 3:00 PM: Lecture 3: Managing Safety Information

  • Basics of clinical trial safety reporting to and public
  • Handling suspending and terminating clinical trials
  • FDA meetings for safety issues
  • Amending clinical protocols and Investigator’s brochures
  • Amending informed consent and re-consenting trial participants without prejudice
  • Educating investigators and teams about safety issues

3:00 – 3:15 PM: Break

3:15 – 4:30 PM: Lecture 4: Post-Market Safety Events and Product Recalls

  • Best practices for pharmacovigilance
  • Managing and reporting post-market safety information
  • Registry clinical trials and patient surveys
  • Physician focus groups
  • Product recalls without long-term pain to the manufacturer
  • Handling drug shortages and manufacturing crises

8:30 AM - 3:30 PM

8:30 – 10:00 AM: Lecture 5: Regulatory Crises During the Investigational Phase of Development

  • Meeting FDA reviewers and other ways to interact
  • Issues with recruitment into trials
  • Adaptive clinical trial designs and high placebo effect
  • Best practices for meetings with the FDA for drugs, biologics and medical devices
  • Handling different regulatory jurisdictions for multinational trials

10:00 – 10:15 AM: Break

10:15 – 12:00 noon: Lecture 6: Dispute Resolution with the FDA

  • FDA guidance documents on dispute resolution with reviewers and sponsors
  • Best practices to address disagreements with data analysis from clinical trials
  • Trouble-shooting private meetings with FDA and advisory committee meetings
  • Best practices to get FDA on your side
  • Rules for dispute resolutions with FDA
  • When to involve legal experts and when to avoid

12:00 – 12:45 PM: Lunch

12:45 – 2:15 PM: Lecture 7: Negative Findings from an FDA Audit

  • Best practices for dealing with an FDA audit
  • Responding to FDA 483s, Warning Letters, and Untitled Letters
  • Time to audit findings, response and FDA action
  • Strategic use of technology for media and investor relations: Press releases and other public announcements
  • Fraud detection, management, and avoidance
  • Affect of the Park Doctrine, and other punitive actions by FDA

2:15 – 2:30AM: Break

2:30 – 3:30PM: Lecture 8: Off-Label Uses, Promotions and Whistle Blowers

  • FDA accepted definition of off-label, in-label, published and anecdotal information.
  • FDA guidance documents about off-label promotion.
  • Review of case-studies from unsuccessful and successful promotion of off-label uses.
  • Practical tips for training of sales and marketing teams in off-label uses of products.
  • Best practices to encourage internal dispute resolutions and reducing events worth whistle-blowing
  • Regulatory strategies for converting off-label uses to in-label uses

Meet Your Instructor

Dr. Mukesh Kumar
PhD, RAC, Senior Director, Regulatory Affairs, Amarex Clinical Research

Dr. Mukesh Kumar leads the Regulatory Affairs and Quality Assurance departments at Amarex, a full service pharmaceutical product development company based in Germantown, MD ( Mr. Kumar’s key expertise is in regulatory affairs, clinical trials and multi-national project management for medicinal and diagnostic products. He has written more than 40 new INDs for FDA submission and reviewed more than 100 INDs. He has been involved in about 100 clinical trials in more than 40 countries, has made several hundred US FDA submissions, and arranged a number of meetings with the US FDA

In addition, he has made regulatory submission in the EU and India. He has conducted GCP, GLP, GMP and GACP audits in the US and several countries in Europe and Asia. He has conducted numerous training workshops in FDA compliance related issues. He has authored numerous articles in peer-reviewed journals. He is a well-known expert in global regulatory affairs and has been an invited speaker at several professional and academic organizations worldwide. He is a certified regulatory affair professional by the Regulatory Affairs Professional Society, USA.

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