Risk Management Plans. As per Section 5 of this Agreement, the SAH’s operational risk will be assessed during the Operating Risk Analysis in order to determine their Risk Management Plan. XXXx in Plans B or C will be moved to a lower-risk plan after 2.5 years if IRCC does not identify any issues or concerns via pre-arrival verifications or post-arrival monitors over the first half of the Agreement duration period. This review will be initiated by IRCC based on available data. Row descriptions Plan A – Low Risk Plan B – Moderate Risk Plan C – Elevated Risk Application Requirements No additional documentation required Settlement plans required for each sponsorship application Settlement plans and proof of funds required for each sponsorship application, with 100% of funds to be demonstrated upfront Pre-arrival verifications IRCC review of settlement and financial information pertaining to a selected case at the post-medical stage, with a sponsor required to demonstrate that 100 per cent of the funds are available to support the case None Cases have the potential of being randomly selected for pre-arrival verification Cases have the potential of being randomly selected for pre-arrival verification Post-arrival monitoring Activities undertaken after arrival to provide a more complete picture of how well the program is working and to ensure refugees are receiving adequate supports as per the program requirements. Cases have the potential of being randomly selected for routine monitoring on a quarterly basis Cases have the potential of being randomly selected for routine monitoring on a bi- monthly basis Cases have the potential of being randomly selected for routine monitoring on a monthly basis Reporting requirements • SAH annual report • SAH annual report • Bi-annual post-arrival settlement reports • SAH annual report • Quarterly post-arrival settlement reports Training requirements Individualized approach focusing on areas in need of improvement as reflected in organizational assessment results Individualized approach focusing on areas in need of improvement as reflected in organizational assessment results Individualized approach focusing on areas in need of improvement as reflected in organizational assessment results APPENDIX 3: PRIVACY AND COMMUNICATIONS BETWEEN A SPONSORSHIP AGREEMENT HOLDER AND IRCC Protecting Client Information Under the Privacy Act, IRCC is required to protect the refugee applicants’ personal information regardless of the individual's immigration status or...
Risk Management Plans. The Parties agree that there will be one Global Risk Management Plan for each Licensed Product, authored by Novartis. The Global Risk Management Plan will be prepared by Novartis in collaboration with Incyte. Incyte shall provide feedback within *** of receipt from Novartis, or such other time as the Parties mutually agree. If a REMS (Risk Evaluation and Mitigation Strategy) is required for the Products by the FDA, Incyte shall be responsible for the authorship and submission. There shall be no material differences in the description of the important safety risks between the Global Risk Management Plan and REMS, as the risks are considered the same in all territories. The REMS will be prepared in collaboration between Novartis and Incyte. Novartis shall provide feedback within *** of receipt from Incyte, or such other time as the Parties may mutually agree. The Parties will exchange all information reasonably requested by a Party that is necessary to fulfill regulatory requirements (e.g. mandatory PSUR updates) for the Global Risk Management Plan. These include, but are not limited to, providing updates on: safety studies and other pharmacovigilance measures, progress in implementing risk minimization activities, and assessment of the performance of any aspect of risk management/minimization related to the Products. Prior to submission of the Global Risk Management Plan to a Regulatory Authority, Novartis shall provide such plan to Incyte for review and Incyte shall have *** to provide comments, which Novartis shall reasonably consider.
Risk Management Plans. 5.3 Each Party shall be responsible for the maintenance and implementation of Risk Management Plans (e.g. Genuine Priligy Program) in countries where the Party (or any Affiliate or licensee of it or its Affiliates) is the MAH according to Legal Requirement. Reference Safety Information (“RSI”)
Risk Management Plans. 4.5.1 If a Risk Management Plan (RMP) for the Product is required by Regulatory Authorities in the Territory as a post-authorization commitment, Dexcel will inform Company within (2) two business days in order to allow an adequate timeframe for preparation of such a document. RMPs will be prepared and updated by Company and provided to Dexcel in a timely manner.
Risk Management Plans. J.01m. Prohibit residences with unrestricted access to soils in front yards or backyards anywhere in the Project Area. 7E
