None of Borrowers or any of its Subsidiaries properties or assets has been used by Borrower or any Subsidiary or, to the best of Borrowers knowledge, by previous Persons, in disposing, producing, storing, treating, or transporting any hazardous substance other than legally. 8(z-!vA< Kh`h`h@V4Y,HcyrU CMa?Bj s4#aPnlH10E3!j ,& Pros: Simplicity, with a clear reference point for detail. The presence of documented step-by-step procedures will help in teaching staff how to carry out things effectively to get optimized results and enhance awareness and working knowledge. You have the right to revoke an authorization except for actions already taken based on your authorization. If applicable, how does your firm document its regular and rigorous reviews, the data and other information considered, order routing decisions and the rationale used, and address any deficiencies? WebTransfer of Regulatory Responsibilities. In conducting its Compliance Review, the GLO and HUD will rely primarily on information obtained from Developers records and reports, findings from on-site monitoring, and audit reports. hbbd```b``"H`>^"HN0* fWI [6'Htl>#70 *5 whether wholesale market makers are conducting adequate execution quality reviews;, whether order routing, handling and execution arrangements (including PFOF agreements) with retail broker-dealers have an impact on the wholesale marker makers order handling practices and decisions, and fulfillment of their best execution obligations; and. We may ask that you submit a written, signed authorization form permitting us to do so and we may charge a reasonable fee for copying and mailing your personal information. You must identify your authorized representatives on a HIPAA-compliant authorization form (available on our website) and explain what type of information they may receive. eCFR :: 21 CFR 312.52 -- Transfer of obligations to a (a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. %PDF-1.5 endobj (\#+r8DCNBG)?Jp7|&PB,)wph These written procedures, including any changes, shall be drafted, reviewed, and approved by the appropriate organizational units and reviewed and approved by the quality control unit. Company Responsibilities The Company will undertake responsibilities as set forth below: University Responsibilities (1) The University will use its best efforts to see that students selected for participation in the ALE are prepared for effective participation in the training phase of their overall education. The Career Education requirement for this Contract is 0 hours. A Player playing in a Match under an Interchange Agreement as detailed at clause 3.9 of the National Player Transfer Transfer of obligation (did not report to FDA) - 1571 form - IND 1.3.1.4. ", The Rules Governing Medicinal Products in the European Union, Volume 4, Good Manufacturing Practice, Medicinal Products for Human and Veterinary Use, Chapter 4: Documentation: "Procedures: (Otherwise known as Standard Operating Procedures, or SOPs), give directions for performing certain operations. Regulatory WebModule 1.3.1.4 Transfer of Obligations Pfizer Confidential 1 TRANSFER OF OBLIGATIONS In compliance with 21 CFR 312.52, Table 1 below lists the Sponsor responsibilities* that were transferred from BioNTech SE to Pfizer Inc. in the conduct of the C4591001 clinical study, with the specific obligations that were transferred. Instructions for Downloading Viewers and Players. The types of information we may collect and disclose include: Information you or your employer provide on applications and other forms, such as names, addresses, social security numbers, and dates of birth Information about your interactions with us or others (such as providers) regarding your medical information or claims Information you provide in person, by phone, in email, or through visits to our website Your Rights When it comes to your health information, you have certain rights. GCP is a bit broader (again, emphasis mine): 5.2.2 Any trial-related duty and function that is transferred to and assumed by a CRO should be specified in writing. ( a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract research organization. Write it Right - Excellent SOPs for Improved Quality and Compliance, Writing and implementing a Standard Operating Procedure (SOP) in a Compliant Laboratory (US FDA, US EPA and OSHA Focus), SOP Development for Medical Device Firms: Utilizing ''lean compliance'' principles to meet your quality system documentation requirements, How to write SOP's that Avoid Human Error, Creating Effective SOPs for Regulatory Compliance, Implementation and Utilization of Standard Operating Procedures (SOPs) at the Clinical Research Site, How to Write SOPs: Tips on Writing the Perfect Document to Impress the FDA, Best Practices for Writing an Effective SOP to Lead to Successful FDA Inspections, Improving Sanitation Standard Operating Procedures In the Food Industry. How does your firm handle fractional share investing in the context of its best execution obligations? WebStandard Operating Procedures: Their Importance and Key Regulatory Requirements. It provides an overview of the European Medicines Agency's position on issues that are typically addressed in discussions or meetings with MAHs in the post-authorisation phase. If all obligations are transferred, a general statement that all obligations have been transferred is acceptable. . SEC.gov Transfer Regulations Definition: 710 Samples | Law Insider Without limitation of the foregoing, promptly following the Closing, Purchaser shall obtain such FDA approvals as are necessary for Purchasers own Product labeling and shall comply with such FDA approvals upon receipt thereof. stream The department head or designee may make reasonable inquiries about employee absences. 0 Best Execution | FINRA.org In these cases, the person requesting your information must accurately verify details about you (e.g., name, identification number, date of birth, etc.) Sec. 1 0 obj % WebTransfer of Obligations can go either way depending on who is holding the IND. File a complaint about fraud or unfair practices. (a) A sponsor may transfer responsibility for any or all of the obligations set forth in this part to a contract Does your firm consider differences among security types within these products, such as the different characteristics and liquidity of U.S. Treasury securities compared to other fixed income securities? the transferee Sponsor IND Obligations. Companies that pay attention to the importance of SOPs are likely to fulfill compliance obligations by incorporating regulations, best practices, and institutional requirements to the product and procedure. Does your firm consider the risk of information leakage affecting pricing when assessing the execution quality of orders routed to a particular venue? We are not required to agree to your request, but if we do, we will abide by our agreement (except when necessary for treatment in an emergency). SOPs Help Fulfill Regulatory Obligations For example, if a family member calls us with prior knowledge of a claim (e.g., providers name, date of service, etc. We may ask that you submit your request in writing. Transfer of Regulatory Obligations listed as TORO Transfer of Regulatory Obligations - How is Transfer of Regulatory O.S.H.A. For the purposes of this document, XYZ Co. will be the transferor and UCSF the transfereeSponsor IND Obligations Under 21 CFR Part 312 Investigational New Drug (IND) Application 21 CFR 312.50 General Responsibilities of SponsorsEnsuring that the investigation is conducted in accordance with the general investigational plan and protocols, as referenced in 21 CFR 312.50;BothMaintaining an effective IND with respect to the investigations, as referenced in 21 CFR 312.50;XYZ Co.Ensuring that Food and Drug Administration (FDA) and all participating investigators are promptly informed of significant new adverse effects or risks with respect to the drug, as referenced in 21 CFR 312.50.XYZ Co. 21 CFR 312.53 Selecting Investigators and MonitorsSelecting qualified investigators, as referenced in 21 CFR 312.53(a);UCSFControlling the shipment of investigational test article, as referenced in 21 CFR 312.53(b);XYZ Co.Qualifying the investigators by obtaining required information and commitments, as referenced in 21 CFR 312.53(c);UCSFSelecting monitors, as referenced in 21 CFR 312.53(d).XYZ Co. 21 CFR 312.55 Informing InvestigatorsProviding an investigator brochure, as referenced in 21 CFR 312.55(a);XYZ Co.Informing investigators of new observations discovered by or reported to the sponsor, particularly with respect to adverse effects and safe use, as referenced in 21 CFR 312.55(b).XYZ Co. 21 CFR 312.56 Review of Ongoing InvestigationsReviewing ongoing investigations, as referenced in 21 CFR 312.56 to include one or more of the following:Monitoring all clinical investigations, as referenced in 21 CFR 312.56(a);XYZ Co. endobj Additional filters are available in search. In the event of any payment by the Secondary Indemnitors of amounts otherwise required to be indemnified or advanced by the Company under the Companys certificate of incorporation or bylaws or this Agreement, the Secondary Indemnitors shall be subrogated to the extent of such payment to all of the rights of recovery of Indemnitee for indemnification or advancement of expenses under the Companys certificate of incorporation or bylaws or this Agreement or, to the extent such subrogation is unavailable and contribution is found to be the applicable remedy, shall have a right of contribution with respect to the amounts paid. We will consider all reasonable requests, and must say yes if you tell us you would be in danger if we do not. WebA transaction includes a deposit; a withdrawal; a transfer between accounts; an exchange of currency; an extension of credit; a purchase or sale of any stock, bond, certificate of deposit, or other monetary instrument or investment security; or any other payment, transfer, or delivery by, through, or to a bank. SOP The University will retain ultimate responsibility for the education of its students. %%EOF You can file a complaint with the U.S. Department of Health and Human Services Office for Civil Rights. Y Information for Regulatory Compliance Each of the Company and the Depositary shall provide to the other, as promptly as practicable, information from its records or otherwise available to it that is reasonably requested by the other to permit the other to comply with applicable law or requirements of governmental or regulatory authorities. Clinical Data and Regulatory Compliance The preclinical tests and clinical trials, and other studies (collectively, studies) that are described in, or the results of which are referred to in, the Registration Statement or the Prospectus were and, if still pending, are being conducted in all material respects in accordance with the protocols, procedures and controls designed and approved for such studies and with standard medical and scientific research procedures; each description of the results of such studies is accurate and complete in all material respects and fairly presents the data derived from such studies, and the Company and its subsidiaries have no knowledge of any other studies the results of which are inconsistent with, or otherwise call into question, the results described or referred to in the Registration Statement or the Prospectus; the Company and its subsidiaries have made all such filings and obtained all such approvals as may be required by the Food and Drug Administration of the U.S. Department of Health and Human Services or any committee thereof or from any other U.S. or foreign government or drug or medical device regulatory agency, or health care facility Institutional Review Board (collectively, the Regulatory Agencies); neither the Company nor any of its subsidiaries has received any notice of, or correspondence from, any Regulatory Agency requiring the termination, suspension or modification of any clinical trials that are described or referred to in the Registration Statement or the Prospectus; and the Company and its subsidiaries have each operated and currently are in compliance in all material respects with all applicable rules, regulations and policies of the Regulatory Agencies. Borrower (a) has complied in all material respects with all Requirements of Law, and (b) has not violated any Requirements of Law the violation of which could reasonably be expected to have a material adverse effect on its business. Additional filters are available in search. Cons: Potential for inconsistency with contracts or misrepresentations caused by summary. How to Prepare a Standard Operating Procedure (SOP)? WebNo credit card required. Inspection; Compliance Lessor and Lessor's Lender(s) (as defined in Paragraph 8.3(a)) shall have the right to enter the Premises at any time, in the case of an emergency, and otherwise at reasonable times, for the purpose of inspecting the condition of the Premises and for verifying compliance by Lessee with this Lease and all Applicable Laws (as defined in Paragraph 6.3), and to employ experts and/or consultants in connection therewith and/or to advise Lessor with respect to Lessee's activities, including but not limited to the installation, operation, use, monitoring, maintenance, or removal of any Hazardous Substance or storage tank on or from the Premises. > y+ bjbj~~ p { { $" T 3 3 3 3 3 $ W W W P L , W : L k k k 4 4 4 3: 5: 5: 5: 5: 5: 5: , h. Cons: Contracts do not always utilize consistent headers and footers that identify the study and the vendor. 1 The GLO or HUD will periodically monitor and audit Developers compliance with the requirements of this Agreement, the CDBG Regulations, the CDBG Single Family Rental Housing Guidelines, and any and all other Governmental Requirements, in accordance with GLO Compliance Monitoring Procedures during the term. 574 0 obj <> endobj For the purposes of this document, XYZ Co. will be the transferor and . FINRA Rule 5310 (Best Execution and Interpositioning) requires that, in any transaction for or with a customer or a customer of another broker-dealer, a member firm and persons associated with a member firm shall use reasonable diligence to ascertain the best market for the subject security and buy or sell in such market so that the resultant price to the customer is as favorable as possible under prevailing market conditions. We will comply with your request if it is reasonable and continues to permit us to collect premiums and pay claims under your policy, including issuing certain explanations of benefits and policy information to the BlueShield of Northeastern New York is a division of HealthNow New York Inc., an independent licensee of the BlueCross BlueShield Association. If you are not present, if it is an emergency, or you are not able to give us permission, we may give your information to a family member, friend, or other person if sharing your information is in your best interest. endstream endobj 575 0 obj <>/Metadata 21 0 R/Outlines 28 0 R/Pages 572 0 R/StructTreeRoot 32 0 R/Type/Catalog/ViewerPreferences 592 0 R>> endobj 576 0 obj <>/MediaBox[0 0 612 792]/Parent 572 0 R/Resources<>/Font<>/ProcSet[/PDF/Text/ImageB/ImageC/ImageI]/XObject<>>>/Rotate 0/StructParents 0/Tabs/S/Type/Page>> endobj 577 0 obj <>stream FOOD AND DRUG ADMINISTRATION Transfer The Secondary Indemnitors are express third-party beneficiaries of the terms of this Section 15. PART 312 -- INVESTIGATIONAL NEW DRUG APPLICATION, Subpart D - Responsibilities of Sponsors and Investigators. 3 0 obj Sec. We will not retaliate against you for filing a complaint. SEC.gov Department Responsibilities The use of sick leave may properly be denied if these procedures are not followed. Web 312.52 Transfer of obligations to a contract research organization. > y+ bjbj p $" T .

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