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Event Details:                                                                                                                                                          

To combat drug shortages in hospitals, the FDA issued a draft guidance that instructs manufacturers of prescription drug and biologic products as to how they should notify the FDA if a shortage is encountered or anticipated. Manufacturers are going to be required to provide detailed explanations as to why a shortage is anticipated. This naturally raises a whole host of potential legal pitfalls for the companies involved.

In this LIVE Webcast, some of the food and drug industry’s great minds share their sense of the best practices out there in addressing the problems. Topics to be discussed will address key concerns, including:



Course Level: Intermediate
Prerequisite: None
Method Of Presentation: Group-Based-Internet
Developer: The Knowledge Group, LLC
Recommended CLE/CPE Hours: 1.75 - 2.0
Advance Preparation: Print and review course materials
Course Code: 124330
Course Fee: $199 - $249 (Early Bird Discounted Rate - on or before )
                       $299 - $349 (Regular Rate - registration after )
                       $149 (Government / Nonprofit Rate)
                       

 

Featured Speakers for Understanding FDA’s Draft Guidance for Drug Shortage Notification LIVE Webcast :


Agenda  (coming soon)


**Information regarding the faculty panel will be posted shortly.
Please check back for updates.**



Who Should Attend?

- In-house Counsel for Food & Drug Manufactures
- FDA Attorneys
- Pharma Industry Lawyers
- Consultants
- General Counsel
- Senior Management
- Senior Executives
- Marketing/Sales Executive
- Legal Executive
- Operations Director
- Professionals coming from Pharmaceutical Firms
- Consultants & Clients in the Pharmaceutical Industries
- Drug Manufacturing Executives

Why Attend?

This is a must attend event for drug manufacturers and professionals who would like to know more about the FDA's draft guidance, its purpose and importance.

- Guidance and best practices regarding reading & interpreting financial statements
- Hear directly from experienced practitioners & thought leaders
- Interact directly with panel during Q&A

Click the "Register" button below and be in the know! Significant discounts apply to those who register in advance!

Registration Information:                                                                                                                                    


** Discounts apply for early registration

Disclaimer:
Please note, the event date is firm although it may be subject to change. Please click here for details.
The Knowledge Group, LLC is producing this event for information purposes only. We do not intend to provide or offer business advice. The contents of this event are based upon the opinions of our speakers. The Knowledge Congress does not warrant their accuracy and completeness. The statements made by them are based on their independent opinions and does not necessarily reflect that of The Knowledge Congress' views. In no event shall The Knowledge Congress be liable to any person or business entity for any special, direct, indirect, punitive, incidental or consequential damages as a result of any information gathered from this webcast.

 

 

 

 


Understanding FDA’s Draft Guidance for Drug Shortage Notification
LIVE Webcast
Speaker Firms:




 

The Knowledge Group, LLC is registered with the National Association of State Boards of Accountancy (NASBA) as a sponsor of continuing professional education on the National Registry of CPE Sponsors. State boards of accountancy have final authority on the acceptance of individual courses for CPE credit. Complaints regarding registered sponsors may be addressed to the National Registry of CPE Sponsors, 150 Fourth Avenue North, Suite 700, Nashville, TN, 37219-2417. Website: www.nasba.org



 

We are an approved multi-event sponsor in the state of California. Our provider ID is: 14451. In Texas, Illinois, and Virginia, we submit programs for individual approval in advance. In all other states, once attendance is verified, participants are emailed an official certificate of attendance which they submit to their respective State Bar Associations. Our programs are created with continuing education in mind and are therefore designed to meet the requirements of State Bar Associations. The State Bars will have the final determination on whether to provide credit or not. If you have any questions, please email our CLE coordinator at: info@knowledgecongress.org

Attention New York Attorneys:

This program is approved for CLE credit under New York’s Approved Jurisdiction policy. The Knowledge Group, LLC is an approved sponsor in the state of California, a New York Approved Jurisdiction. This program fulfills the non-traditional format requirement of exceeding 60 minutes in length. Please note only experienced attorneys (more than 2 years) are eligible to receive CLE credit via non-traditional format learning platforms. The Knowledge Group will verify attendance during the webcast via secret words (3 per credit hour) and by auditing attendees log in and log out records. All verification instructions will be provided during the webcast. Once attendance verification requirements have been completed, the attendee will be issued a certificate of attendance be The Knowledge Group for the course with the recommended number of credit hours. The Certificate of Attendance is normally sent via email in 24 hours or less.

To Claim Your CLE Credits:

The attorney should simply include credits earned via Knowledge Group webcasts when computing the total number of CLE credits completed, and keep the Knowledge Group Certificate of Attendance for a period of at least four (4) years in case of audit. An attorney may count towards her/his New York CLE requirement credit earned through the Approved Jurisdiction policy without notifying the CLE Board.

To learn more about New York’s Approved Jurisdiction policy. Please visit: http://www.nycourts.gov/attorneys/cle/approvedjurisdictions.shtml

Attention Pennsylvania Attorneys:

Knowledge Congress is not yet an Accredited Distance Learning Provider in PA, neither the instructors nor any PA attendees will receive credit for the course.



 
Enrolled Agents Sponsor ID Number: 7602U

We have entered into an agreement with the Office of Professional Responsibility, Internal Revenue Service, to meet the requirements of 31 Code of Federal Regulations, section 10.6(g), covering maintenance of attendance records, retention of program outlines, qualifications of instructors, and length of class hours. This agreement does not constitute an endorsement by the Office of Professional Responsibility as to the quality of the program or its contribution to the professional competence of the enrolled individual.