Sentences with phrase «event reporting requirements»

The law went into effect on July 1, 2007 except for the adverse event reporting requirements.

Not exact matches

Actual results and the timing of events could differ materially from those anticipated in the forward - looking statements due to these risks and uncertainties as well as other factors, which include, without limitation: the uncertain timing of, and risks relating to, the executive search process; risks related to the potential failure of eptinezumab to demonstrate safety and efficacy in clinical testing; Alder's ability to conduct clinical trials and studies of eptinezumab sufficient to achieve a positive completion; the availability of data at the expected times; the clinical, therapeutic and commercial value of eptinezumab; risks and uncertainties related to regulatory application, review and approval processes and Alder's compliance with applicable legal and regulatory requirements; risks and uncertainties relating to the manufacture of eptinezumab; Alder's ability to obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; the uncertain timing and level of expenses associated with Alder's development and commercialization activities; the sufficiency of Alder's capital and other resources; market competition; changes in economic and business conditions; and other factors discussed under the caption «Risk Factors» in Alder's Annual Report on Form 10 - K for the fiscal year ended December 31, 2017, which was filed with the Securities and Exchange Commission (SEC) on February 26, 2018, and is available on the SEC's website at www.sec.gov.

To front - load the story by saying people were being treated in animal stalls, and only later point out it was a free clinic held in a county fairground (rural area, large crowd... likely the only suitable place that passed health and safety requirements for such an event), and to not mention that many if not most of those taking advantage of the free medical care were likely farm workers and not here legally... is beyond poor reporting.

There are unannounced inspections, but oversight depends largely on the requirement that adverse events be promptly reported so that underlying problems can be quickly corrected.

This requirement presented an opportunity to co-design the new event - based reporting solution, and in turn required us to redesign and improve our reporting framework.

· Listening to customer requirements and presenting appropriately to make a sale; · Maintaining and developing relationships with existing customers in person and via telephone calls and emails; · Cold calling to arrange meetings with potential customers to prospect for new business; · Responding to incoming email and phone inquiries; · Acting as a contact between a company and its existing and potential markets; · Gathering market and customer information; · Representing the company at trade exhibitions, events and demonstrations; · Negotiating on price, costs, delivery and specifications with buyers and managers; · Advising on forthcoming product developments and discussing special promotions; · Creating detailed proposal documents, often as part of a formal bidding process which is largely dictated by the prospective customer; · Reporting to Senior Management on sales and potential opportunities in your area; · Reviewing your own sales performance, aiming to meet or exceed targets; · Gaining a clear understanding of customers» businesses and requirements; · Following up with customers for payment; · Doing Quality - Control on products delivered; · Attending team meetings and sharing best practices with colleagues in East Williamsburg, Brooklyn.

[8] In compliance with the requirements of the Ontario Securities Act BCE filed a material change report dated July 5, 2007 concerning the transaction and describing the future events that could affect its completion, including financing covenants, regulatory approvals, and conditions precedent.

The order shall issue as soon as practicable but in any event within 60 days after the filing of a case conference report pursuant to Rule 16.1 or an order by the discovery commissioner or the court waiving the requirement of a case conference report pursuant to Rule 16.1 (f).

Thus, in the final rule, we allow covered entities to disclose protected health information to entities subject to FDA jurisdiction for the following activities: To report adverse events (or similar reports with Start Printed Page 82670respect to food or dietary supplements), product defects or problems (including problems with the use or labeling of a product), or biological product deviations, if the disclosure is made to the person required or directed to report such information to the FDA; to track products if the disclosure is made to a person required or directed by the FDA to track the product; to enable product recalls, repairs, or replacement (including locating and notifying individuals who have received products of product recalls, withdrawals, or other problems); or to conduct post-marketing surveillance to comply with requirements or at the direction of the FDA.

We allow covered entities to disclose protected health information to a person subject to the FDA's jurisdiction, for the following activities: to report adverse events (or similar reports with respect to food or dietary supplements), product defects or problems, or biological product deviations, if the disclosure is made to the person required or directed to report such information to the FDA; to track products if the disclosure is made to a person required or directed by the FDA to track the product; to enable product recalls, repairs, or replacement, including locating and notifying individuals who have received products regarding product recalls, withdrawals, or other problems; or to conduct post-marketing surveillance to comply with requirements or at the direction of the FDA.

The NPRM would have allowed covered entities to disclose protected health information without individual authorization to: (1) A public health authority authorized by law to collect or receive such information for the purpose of preventing or controlling disease, injury, or disability, including, but not limited to, the reporting of disease, injury, vital events such as birth or death, and the conduct of public health surveillance, public health investigations, and public health interventions; (2) a public health authority or other appropriate authority authorized by law to receive reports of child abuse or neglect; (3) a person or entity other than a governmental authority that could demonstrate or demonstrated that it was acting to comply with requirements or direction of a public health authority; or (4) a person who may have been exposed to a communicable disease or may otherwise be at risk of contracting or spreading a disease or condition and was authorized by law to be notified as necessary in the conduct of a public health intervention or investigation.

Commenters said they used this information to comply with FDA requirements such as reporting adverse events, filing other reports, or recordkeeping.

Ensured compliance with protocol guidelines and requirements of regulatory agencies; identified problems and / or inconsistencies and monitor patients» progress to include documentation and reporting of adverse events in the areas of neurology, sleep medicine, and pulmonology.

Review and process ICSRs of adverse events obtained from various sources including spontaneous, clinical trials accurately to determine regulatory reporting requirements and ensure quality data

Kamehameha Schools — Ashburn, VA Summer 2012 Paraprofessional • Maintained clerical records and arranged required reports • Copied, organized, and filed materials for distribution to students • Helped with the care of classroom equipment • Kept the teacher informed of particular requirements or problems of individual students • Took part in staff - development training programs • Decorated the classroom for special events

Office Coordinator • Coordinate and schedule appointments and meetings • Arrange and update HR reports • Maintain leave records for all departments • Take minutes of meetings and distribute to participants • Maintain and manage stationary and office inventory • Arrange special events, meetings, and conferences • Handle all elements of staff travel requirements • Manage interline travel for all employees

• Made presentations in MS PowerPoint • Supported the reporting and data organization requirements of the special events workforce and the office

Project Summary: ARISg is a Drug Safety System which provides all the functionality required to manage adverse event reporting and adverse reaction requirements of different authorities around the world, from case entry to automatic generation of submission ready adverse event (AE) reports including CIOMS I, Med Watch 3500A and many more.

Identify and report events as required based on the REMS requirements for specified medication...

The Chasm Group, LLC and Chasm Institute, LLC (San Bruno, CA) 1997 — 2008 Business Operations Manager • Managed all daily operational tasks for leading multi-million dollar high - tech market strategy consultancy, while providing executive administration to C - level executives and venture capital partners • Developed and managed the firm's annual budget, proposing and implementing expense cuts, producing monthly reports and financial statements, and coordinating with CPA firm for accurate and timely filings • Oversaw all client relationship management efforts while cultivating new business efforts from concept to implementation, providing high - quality service in sales efforts while utilizing new lead tracking system • Negotiated and managed all contracts, stock grants, and financing arrangements, working closely with outside counsel to draft legal documents and resolve LLC - and proprietary - related issues • Led three office space build - outs and two office relocations, managing all aspects of each process under aggressive timeline and budget expectations • Reduced firm telecom expenses by 22 % by streamlining IT objectives, including migration to VOIP phone system, software / hardware purchases, domain renewals, and outsourced technical support • Directed all phases of staff recruitment while creating and implementing all HR policies and programs, including comprehensive employee benefits plans • Supervised multiple administrative staff members, conducted performance appraisals and wage / salary surveys in comparison to incentive program guidelines, and maintained HR files in accordance with legal mandates • Produced all out - going client invoices in an accurate and timely fashion to increase, cash flow and reduce aging receivables, providing consistent attention to overhead costs and vendor arrangements • Administered all company insurance policies, including E&O, general liability, bonds, partner life and disability, conducting annual benefits reviews and employee / company insurance audits • Obtained necessary certificates for consulting contracts while processing federal, state, and local business reporting requirements to maintain licenses and incorporation status • Directed all marketing efforts and oversaw logistical aspects of national educational workshop series, utilizing sponsorship arrangements to offset production costs • Transformed «brochure» website into a dynamic tool to better illustrate company opportunities through relevant case studies, as well as maintaining all other promotional media, including press kits and video Association of California School Administrators (Burlingame, CA) 1993 — 1997 Issues and Planning Committee Coordinator • Executed all phases of event planning and implementation for a membership - driven organization including 23 state committees, 5 task forces, 6 strategic planning conferences, and a conference of 1,500 attendees • Focused on facility evaluations, bid requests, site visits, contract negotiations, and all pre - and post-conference planning processes • Produced statistical and financial reports, including budget projections and cost monitoring for developmental training efforts • Oversaw all participant - level responsibilities, including inquiries, eligibility, registration, correspondence, and billing statements • Managed all legal professional standards calls for Northern California regions, including the processing of attorney authorizations, the preparation of legal assistance letters, and liens on cause of action • Served as second point of contact for computer inquiries and troubleshooting efforts as well as provided back - up executive administrative support for Executive Director, Committee Chairs, and the State Superintendent of Public Instruction • Held responsibility for software installation and hardware configuration while performing weekly AS / 400 backup and report generation

Is there a publication that they can look at to see what the requirements are for reporting in the event of an audit?