Field Force Monitoring and Review Efforts. Within 90 days after the Effective Date, Indivior shall establish a comprehensive Field Force Monitoring Program (FFMP) to evaluate and monitor its sales personnel’s interactions with HCPs and HCIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales personnel’s interactions with HCPs and HCIs and to identify potential off-label promotional activities or other improper conduct. As described in more detail below, the FFMP shall include: (1) a Speaker Monitoring Program; (2) direct field observations (Observations) of sales personnel; and (3) the monitoring and review of other records relating to sales personnel’s interactions with HCPs and HCIs (Records Reviews).
Field Force Monitoring and Review Efforts. Within 90 days after the Effective Date, RMS shall establish a comprehensive Field Force Monitoring Program (FFMP) to evaluate and monitor its sales personnel’s interactions with HCPs and HCIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales personnel’s interactions with HCPs and HCIs and to identify potential off-label promotional activities or other improper conduct. As described in more detail below, the FFMP shall include: (1) direct field observations (Observations) of sales personnel and (2) the monitoring and review of other records relating to sales personnel’s interactions with HCPs and HCIs (Records Reviews).
Field Force Monitoring and Review Efforts. To the extent not already accomplished, within 120 days after the Effective Date, AstraZeneca shall establish a comprehensive Field Force Monitoring Program (FFMP) to evaluate and monitor its sales representatives’ interactions with HCPs and HCIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales representatives’ interactions with HCPs and HCIs and to identify potential off-label promotional activities or other improper conduct. As described in more detail below, the FFMP shall include: 1) a Speaker Monitoring Program; 2) direct field observations (Observations) of sales representatives; and 3) the monitoring and review of other records relating to sales representatives’ interactions with HCPs and HCIs (Records Reviews). Corporate Integrity Agreement AstraZeneca Prior to the Effective Date, AstraZeneca provided electronic tablet notebooks (the Tablet PC System) to all of its field-based sales representatives. These electronic notebooks are part of a centralized, electronic system to be used by sales representatives in connection with the detailing of HCPs (detailing system). AstraZeneca shall maintain the Tablet PC System or another electronic detailing system that includes the controls described in this paragraph throughout the term of the CIA. The detailing system shall continue to include controls designed to ensure compliance with Federal health care program and FDA requirements and shall permit the tracking of detailing-related activities, including the submission of Inquiries (as defined above in Section III.B.3.g) and the distribution of samples of Government Reimbursed Products to HCPs. The detailing system shall continue to include a centralized mechanism through which sales representatives may submit Inquiries to Medical Affairs. With regard to the distribution of samples, the detailing system and its controls shall prevent the delivery of samples of particular Government Reimbursed Products to HCPs that AstraZeneca has identified as belonging to a specialty group that is unlikely to prescribe the particular Government Reimbursed Product for a use consistent with the FDA-approved label for the product.
Field Force Monitoring and Review Efforts. To the extent not already accomplished, within 120 days after the Effective Date, Forest shall establish a Field Force Monitoring Program (FFMP) to evaluate and monitor various aspects of Forest’s interactions with HCPs and HCIs, including interactions between sales representatives and HCPs and HCIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales representatives’ interactions with HCPs and HCIs and to identify potential off-label promotional activities or other improper conduct. As set forth in more detail below, the FFMP shall include: 1) a Speaker Monitoring Program; 2) direct field observations (Observations) of sales representatives; and 3) the monitoring and review of other records relating to sales representatives’ interactions with HCPs and HCIs (Records Reviews).
Field Force Monitoring and Review Efforts. To the extent not already accomplished, within 120 days after the Effective Date, Cephalon shall establish a Field Force Monitoring Program (FFMP) to evaluate and monitor field sales force representatives’ interactions with HCPs. The FFMP shall be a formalized process designed to directly observe the appropriateness of field sales force representative’s interactions with HCPs and to identify potential off-label promotional activities. Under this program, Cephalon compliance personnel, or appropriately trained designees who are not from marketing or the field sales organizations and who are not within three levels of the field sales force representative’s reporting structure, shall conduct direct field observations (Observations) of field sales force representatives to assess whether the messages delivered and materials distributed to HCPs are consistent with Cephalon’s Policies and Procedures. These Observations shall be full day ride-alongs with field sales representatives, and each Observation shall consist of directly observing all meetings between a sales representative and HCPs during the workday. The Observations shall be scheduled throughout the year, randomly selected by Cephalon compliance personnel, include each therapeutic area and actively promoted product, and be conducted across the United States. At the completion of each Observation, Cephalon compliance personnel or the designee shall prepare a report which includes:
1) the identity of the sales representative;
2) the identity of the Cephalon compliance professional;
3) the date and duration of the Observation;
4) the product(s) promoted during the Observation;
5) an overall assessment of compliance with Cephalon policy; and
6) the identification of any potential off-label promotional activity by the field sales representative. Cephalon compliance personnel shall conduct at least 30 full-day Observations during each Reporting Period. The number of inspections conducted for each therapeutic area and product shall be proportional in number to the size of each therapeutic area and product, and shall be conducted across the United States. In the event that a compliance issue, including potential off-label promotion, is identified during any Observation, Cephalon shall investigate the incident consistent with established Policies and Procedures for the handling of investigations. As part of the formal investigation procedures, findings shall be made and all necessary and appropriate responsive a...
Field Force Monitoring and Review Efforts. Within 120 days after the Effective Date, Life Spine shall establish a comprehensive Field Force Monitoring Program (“FFMP”) to evaluate and monitor its sales personnel’s interactions with HCPs and HCIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales personnel’s interactions with HCPs and HCIs and to identify potential improper conduct. As described in more detail below, the FFMP shall include: (1) direct field observations (“Observations”) of sales personnel and (2) the monitoring and review of other records relating to sales personnel’s interactions with HCPs and HCIs (“Records Reviews”).
Field Force Monitoring and Review Efforts. To the extent not already accomplished, or as excepted in Section III.L.1, within 120 days after the Effective Date, Par shall establish a comprehensive Field Force Monitoring Program with respect to Government Reimbursed Products (FFMP) to evaluate and monitor its sales personnel’s interactions with HCPs and HCIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales personnel’s interactions with HCPs and HCIs and to identify potential off-label promotional activities or other improper conduct. As described in more detail below, the FFMP shall include: (1) a Speaker Monitoring Program if Par engages in speaker program activities; (2) direct field observations (Observations) of sales personnel; and (3) the monitoring and review of other records relating to sales personnel’s interactions with HCPs and HCIs (Records Reviews).
Field Force Monitoring and Review Efforts. Within 120 days after the Effective Date, Essilor shall establish a comprehensive Field Force Monitoring Program (FFMP) to evaluate and monitor its sales personnel’s interactions with ECPs and ECIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales personnel’s interactions with ECPs and ECIs and to identify potential improper promotional activities or other improper conduct. As described in more detail below, the FFMP shall include: (1) direct field observations (Observations) of sales personnel and (2) the monitoring and review of other records relating to sales personnel’s interactions with ECPs and ECIs (Records Reviews).
Field Force Monitoring and Review Efforts. Within 120 days after the Effective Date, ACell shall establish a comprehensive Field Force Monitoring Program (FFMP) to evaluate and monitor its sales personnel’s interactions with HCPs and HCIs. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales personnel’s interactions with HCPs and HCIs and to identify potential off-label promotional activities or other improper conduct. As described in more detail below, the FFMP shall include: (1) a Speaker Monitoring Program and (2) direct field observations (Observations) of sales personnel.
Field Force Monitoring and Review Efforts. Within 120 days after the Effective Date, Avanir shall establish a comprehensive Field Force Monitoring Program (FFMP) to evaluate and monitor its sales personnel’s interactions with HCPs and HCIs relating to Government Reimbursed Products. The FFMP shall be a formalized process designed to directly and indirectly observe the appropriateness of sales personnel’s interactions with HCPs and HCIs and to identify potential off-label promotional activities or other improper conduct. As described in more detail below, the FFMP shall include: (1) a Speaker Monitoring Program; (2) direct field observations (Observations) of sales personnel; and (3) the monitoring and review of other records relating to sales personnel’s interactions with HCPs and HCIs (Records Reviews).
