Safe Rx

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Many significant regulatory changes are on the way which will govern how pharmaceutical & biotech firms market & sell their products. Some have referred to the changes as a broad and multifaceted attack on advertising promotions and pricing models. Many states have independently adopted policies that may have a broader impact as other states consider enacting similar laws. States like Vermont already limit the amount pharmaceutical and biotech companies can spend marketing. Washington DC’s Health SafeRx ACT aims to require pharmaceutical sales representatives to be licensed in order to sell products to doctors, clinics and others. Some states require an annual disclosure of marketing budgets. Other laws pending such as the Sunshine Act propose many sweeping changes to the landscape. These critical regulatory changes will have a huge impact on the pharmaceutical and biotech marketing. Companies may have to consider completely overhauling their marketing & training programs to remain in compliance.

The Knowledge Group is producing a LIVE web cast which will explore the issues and concerns surrounding this change and will provide valuable information analysis and best practices. Critical Regulatory Changes Governing the Marketing of Pharmaceuticals & Biotech Products - How Will It Affect Your Firm? LIVE Webcast is a must attend for: Pharmaceutical & Biotech Companies and their Marketing and Sales Teams, Risk Managers, Consultants, Industry Attorneys, and watchers.

Course Level: Intermediate
Prerequisite: None
Method Of Presentation: Group-Based-Internet
Developer: The Knowledge Conference
Recommended CLE/CPE Hours: 1.75 - 2.0
(Please note, your State Bar or Accounting Board will make the final determination with respect to continuing education credit. If you are applying for CLE credit in Texas you must register 20 days before the event date.)
Advance Preparation: Print and review course materials
Course Code: 093867
Recording Fee: $299 (Please click here for details)
NASBA Sponsor Number: 109004

 

Featured Speakers for The Marketing of Pharmaceuticals & Biotech Products live webcast:


  Event Talking Points (click here to view more)
SEGMENT 1:


Arnold I. Friede, Esq., Counsel, Former Associate Chief Counsel, Food and Drug Administration,
McDermott Will & Emery LLP

- Set the stage – Current Enforcement and regulatory Environment

SEGMENT 2:


Robert N. Weiner, Esq., Partner, Former Senior Counsel, White House Counsel's Office,
Arnold & Porter

** Speaker Talking Points to be added soon.. **

SEGMENT 3:


Kelly N. Reeves, Partner,
King & Spalding LLP

- Key requirements of state marketing cost disclosure laws, state marketing code of conduct laws,
  state gift ban laws, and the D.C. SafeRx Act detailer licensing law
- Putting these state law requirements into context -- pending state legislation, the federal Physician
  Payments Sunshine Act
- What are the trends in new state marketing laws and practical compliance challenges that industry
  face?

SEGMENT 4:


James E. Dutton, President Emeritus, CMR Institute, Executive Advisor, Advocacy and Strategic Development, Medical Representatives, Certification Commission,
CMR

- Safe Rx Act – What happened and will it make a difference in patient care?
- Industry Reaction – diversity of response
- Lessons Learned – What could be done differently?
- Implications Going Forward
- Proactive Solutions and the” window of opportunity”



McDermott Will & Emery LLP
Arnold I. Friede, Esq.
Counsel, Former Associate Chief Counsel, Food and Drug Administration
speaker bio »»

Arnold & Porter
Robert N. Weiner, Esq.
Partner, Former Senior Counsel, White House Counsel's Office
speaker bio »»

King & Spalding LLP
Kelly N. Reeves
Partner
speaker bio »»

CMR
James E. Dutton
President Emeritus, CMR Institute, Executive Advisor, Advocacy and
Strategic Development, Medical Representatives, Certification Commission
                        speaker bio »»

Who Should Attend?

- Healthcare - Pharmaceutical Companies
- Chief Marketing Officers
- Sales Directors
- Risk Managers
- Consultants
- Pharmaceutical Industry Attorneys

Why Attend?

This is a must attend event for anyone interested in understanding Marketing of Pharmaceuticals & Biotech Products.
- New guidance explained by the most qualified key leaders & experts
- Hear directly from key regulators & thought leaders
- Interact directly with panel during Q&A

Registration Information:                                                                                                                                    


 

 

 

 

 

 


Critical Regulatory Changes Governing the Marketing of Pharmaceuticals & Biotech Products - How Will It Affect Your Firm?
Speaker Firms:



Arnold & Porter


King & Spalding LLP









Media Partner:



Examining practice management, policy, technology, finance and legal issues for physicians.



 

The Knowledge Conference 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 all State Bar Associations. 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



 
Enrolled Agents Sponsor ID Number: 760

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.