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) |
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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
10:30 – 10:45 AM: Break 10:45 – 12:30 noon: Lecture 2: Changing Trends in Drug Discovery Research
12:30 – 1.30 PM: Lunch 1:30 – 3:00 PM: Lecture 3: Managing Safety Information
3:00 – 3:15 PM: Break 3:15 – 4:30 PM: Lecture 4: Post-Market Safety Events and Product Recalls
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8:30 AM - 3:30 PM 8:30 – 10:00 AM: Lecture 5: Regulatory Crises During the Investigational Phase of Development
10:00 – 10:15 AM: Break 10:15 – 12:00 noon: Lecture 6: Dispute Resolution with the FDA
12:00 – 12:45 PM: Lunch 12:45 – 2:15 PM: Lecture 7: Negative Findings from an FDA Audit
2:15 – 2:30AM: Break 2:30 – 3:30PM: Lecture 8: Off-Label Uses, Promotions and Whistle Blowers
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Meet Your Instructor
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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 (www.amarexcro.com). 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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