You are here
Medtech Compliance Virtual Bootcamps
AdvaMed and Porzio Life Sciences have teamed up to offer a four-part virtual program to help you and your team mitigate the burden of compliance. These programs will provide you with a thorough understanding of the compliance framework, as well as practical approaches for addressing challenges and effectively managing compliance.
Session One: Introduction to Compliance Framework
Tuesday, March 2, 2021 | 1:30 pm - 2:30 pm ET
This session will introduce the four legs of the compliance framework: Culture, Effective Compliance Program Development and Implementation, Government Expectations and Assessing Your Risk Profile.
Session Two: Compliance Challenge: Health Care Professional Engagements
Thursday, March 4, 2021 | 1:30 pm - 2:30 pm ET
- Culture: The importance of culture when determining how and why to engage HCPs
- Effective Compliance Program Development and Implementation: What are the rules of engagement?
- Government Expectations: Key risks and requirements
- Assessing Your Risk Profile: Implementing a compliant HCP engagement process that fits your organization
Session Three: Compliance Challenge: Grants, Donations and Other Funding
Tuesday, March 9, 2021 | 1:30 pm - 2:30 pm ET
- Culture: Why provide funding?
- Effective Compliance Program Development and Implementation: Understanding the challenges with funding
- Government Expectations: Compliance issues with grants and donations
- Assessing Your Risk Profile: Facilitating compliant funding
Session Four: Compliance Challenge: Federal, State and International Transparency, Disclosures and Reporting
Thursday, March 11, 2021 | 1:30 pm - 2:30 pm ET
- Culture: Sunshine reporting - Creating a culture of compliance
- Effective Compliance Program Development and Implementation: The expansion of Sunshine Act reporting to include additional health care professionals
- Government Expectations: State law compliance obligations
- Assessing Your Risk Profile: OUS transparency and related considerations
Michelle Axelord, JD
Michelle Axelrod is a Vice President of Porzio Life Sciences and a member of its Executive Committee. As a former in-house counsel and leader in compliance, Ms. Axelrod is well-versed in the inner workings of the life sciences industry. She understands the collaborative effort required for crafting and maintaining successful and cost-effective compliance programs, as well as the challenges associated with such programs. Ms. Axelrod applies her insight and experience to develop and deliver innovative and practical solutions to our pharmaceutical, medical device and biotechnology global customers. She also oversees quality control and marketing endeavors, and manages PorzioLS personnel.
In addition to these responsibilities, Ms. Axelrod is a principal of Porzio, Bromberg & Newman P.C. in the Life Sciences Compliance and Regulatory Counseling team, and a member of the firm's Management Committee. In this role, she counsels life science companies on legal, regulatory and compliance issues related to product communications, interactions with healthcare professionals, and related sales, marketing and distribution activities. She also provides direction and oversight on risk assessments and audits, and the development and implementation of effective policies, procedures and training programs, to support companies’ compliance initiatives.
Jennifer A. Romanksi, JD
Jennifer A. Romanski is Vice President of Porzio Life Sciences, LLC. In collaboration with the other Directors of Regulatory and Compliance Services, Ms. Romanski is responsible for ensuring that all products are relevant to the needs of the industry and working with other personnel to create new products. Ms. Romanski is also a principal of Porzio, Bromberg & Newman P.C. and a co-chair of the
firm’s Life Sciences Compliance and Regulatory Counseling team. Ms. Romanski counsels pharmaceutical and device manufacturers on federal and state fraud and abuse laws, sampling compliance, and state disclosure and prohibition laws. She develops policies and procedures and conducts training programs for clients, in connection with their comprehensive compliance programs. She evaluates grants and contributions, drug and device advertising and promotion, and marketing activities directed to healthcare professionals. Additionally, Ms. Romanski provides general business counseling on contractual issues. Ms. Romanski received a J.D. from University of Pennsylvania Law School, in 1997. She earned her B.A. in Biological Basis of Behavior, cum laude, from University of Pennsylvania in 1994.
Registration Fees for Each Session
AdvaMed Member Registration: $99.00
Accel Member Registration: $99.00
Government and Non-Profit Registration: $99.00
Non-Member Registration: $199.00
- Register for more than one session and receive 20% off with the code BUNDLEIT
- Get a group of two or more together and receieve 20% of registration for each person with the code CBGROUP