zilongwang/ReadingBank huggingface dataset:
Reserves team or other teams are playing same day/weekend U19 team or other teams are playing same day/weekend Finals Qualification 4 VFL/TAC/AFL restrictions 12 or more games in AFL, VFL, TAC is ineligible to play EFL Finals 12 or more games in AFL, VFL, TAC is ineligible to play EFL Finals Any player that plays a Senior game AFL, VFL is ineligible to play EFL Reserves finals 12 or more in AFL, VFL, TAC is ineligible to play EFL Finals 9 or more games in AFL, VFL, TAC Cup is ineligible to play EFL Junior Finals n/a 7 or more games with a VFLW team is ineligible to play finals in the SEWL. Penalty Unit 1 penalty unit = $16 1 penalty unit = $16 1 penalty unit = $16 1 penalty unit = $16 1 penalty unit = $16 Players Points & Player Payments Salary Cap Div 1 $225k, Div 2 $150k, Div 3 $100k, Div 4 $75k Points Cap 47 Any cash awards or player payments included in Salary Cap n/a n/a n/a
UNDERGRADUATE (IELTS 6.0) GCSE or O-Level English Grade C Cambridge IGCSE English as a First Language (Syllabus 0500 and 0522) Grade C Minimum scores: Reading – Grade E Writing – E Speaking – Grade D (0522) or 2 (0500) Listening – Grade D (0522) or 2 (0500) Cambridge IGCSE English as a Second Language (Syllabus 0510 and 0511) Grade C Minimum scores: Reading – Grade D Writing – Grade D Speaking – Grade C (0511) or 2 (0510) Listening – Grade A A Level English Language Grade C 6.0 (with no component score lower than 5.5) SELT from UKVI approved centres. We vouch for tests taken at other centres Validity is two years of course commencement date* TOEFL Ibt (Note: we do NOT accept ITP) 80 with minimum subscores of 20 Cambridge English: First On new scoring scale from January 2015,
International Baccalaureate Standard Level (Grade 6 in English Language and Literature) Higher Level (Grade 6 in English B) POSTGRADUATE GCSE or English Grade C A Level English Language Grade C Cambridge IGCSE English as a First Language (Syllabus 0500 and 0522) C Minimum score of D Cambridge IGCSE English as a Second Language (Syllabus 0510 and 0511) Grade C Minimum score of D Cambridge English: First Cambridge English: Advanced Cambridge English: Proficiency On new scoring scale from January 2015, overall score of minimum 176 and component scores of 169 or above required 6.5 (with no component score lower than 6.0) SELT from UKVI approved centres. We vouch for tests taken at other centres Validity is two years of course commencement date Michigan English Language Assessment Board 85 or above Trinity College – Integrated Skills in English ISEIII - pass in all four components SELT – only when taken at a UK centre.
We vouch for tests taken at other centres Validity is two years of course commencement date TOEFL iBT 91 (with minimum grades of 21 in each component) SoLETS (School of Languages English Testing Service) Merit (75%) with no component below pass (65%) Pearson Test of 67 with minimum of 60 in each component
Expressions of interest Would you like to upgrade your conventional block and chain mooring to an Environmentally Friendly Mooring? Hunter Local Land Services is offering a 50% rebate to upgrade moorings in Lake Macquarie to Environmentally Friendly Moorings with funding from the NSW Government and the NSW Recreational Fishing Trust Habitat Action Grants. Installations must be completed by 10 June 2017. Environmentally Friendly Moorings are safe, secure and good for the environment. These independently tested and certified designs utilise shock absorbers that prevent the mooring tackle coming into contact with the seabed and damaging sensitive seagrass habitats. A 50% rebate is being offered for two types of Environmentally Friendly Moorings pictured below including the Seagrass Friendly Mooring (left) and Eco Mooring (right). The cost of a full upgrade is $3,300 (including GST) so a rebate of $1,650 is available to upgrade to either type of mooring. To lodge an expression of interest please use the form provided including your name, mailing address, contact number, and mooring location and number at the address listed below. Applications will be assessed and prioritised according to proximity to sensitive habitat locations. Funding is limited and no guarantee is offered that all expressions of interest will receive funding. Expressions of interest will close Midnight 31 May 2017 and should be emailed to incentives.program@lls.nsw.gov.au or mailed to Hunter Local Land Services Private Bag 2010 Paterson NSW 2421. For further information about the Environmentally Friendly Mooring rebate offer: website: phone: (02) 4930 1030 email: For detailed technical information about the moorings contact the suppliers directly (details below) Seagrass Friendly Moorings: Des Maslen – 0418 232 854 – admin@seagrassmooring.com.au Eco Mooring: Jody Waters - 0411 472 763 – Expression of Interest for an Environmentally Friendly Mooring upgrade in Lake Macquarie To apply for a 50% to upgrade a conventional block and chain mooring to an Environmentally Friendly Mooring, please complete the form below and email it to incentives.program@lls.nsw.gov.au. For successful applicants this form will be considered an application for funding. APPLICANT and MOORING DETAILS Applicant Name : Contact Details:
1.7 Range & Dynamic Named Range OFFSET Select from B6 to B 13 – Go to Formula Tab – Select Define Name – Write Name as “Price” - Refers to ='Named Range'!$B$6:$B$13 Click OK To Perform SUM Range in Cell B19 = Sum(Price) Prepare Script List – in Cell B61 – Go to Data Tab – Select Data Validation – Select List – Select Source = A8:A58 (or) Select the Script List – Define Name as “Script” – Go to Data Validation – Select List – Source =Script - Drop menu will appear. Prepare Companies List – in Cell B63 - Select the Companies List (B8:B58) – Define Name as “Company” – Go to Data Tab – Select Data Validation – Select List – Select Source = Company - Drop menu will appear. Prepare Header List in Cell B65 - Select the Headers (A7:K7) – Define Name as “Header” – Go to Data Tab – Select Data Validation – Select List – Select Source = Header - Drop menu will appear. Select all Data points one by one Define Name with its respective Header Prepare Dynamic List - Go to Data Tab – Select Data Validation – Select List – Select Source =INDIRECT($C$65). Drop menu will appear. 1.8 Dynamic Named Range INDEX Prepare Script List – in Cell B61 – Go to Data Tab – Select Data Validation – Select List – Select Source = A8:A58. Drop menu will appear. Prepare Companies List – in Cell B63 – Go to Data Tab – Select Data Validation – Select List – Select Source = B8:B58. Drop menu will appear.
Table 2 Determinants of the Reinvestment Rate Model Type: Ordinary Squares Two-Stage Least Squares Two-Stage Least Squares Two-Stage Least Squares Variable 0.019 0.034 0.000 0.014 YIELD 0.972 PAYOUT 0.144 DIVTA 0.391 ROE 0.117 0.020 * 0.950 0.556 0.063 0.072 0.629 0.020 * 0.543 0.539 0.731 0.527 DISC 0.005 0.006 0.038 * 0.006 PP 0.011 * 0.021 * 0.016 * 0.018 * 0.003 0.001 0.216 0.009 0.012 * 0.010 0.664 0.030 * BETA 0.097 0.092 0.703 0.147 SIZE 0.605 0.483 0.405 0.353 0.004 0.156 0.019
Table V continued Differences in firm-specific risks across cohorts after controlling for intangible intensity and product-market uncertainty B: Earnings volatility No controls Control for cohorts Control for intangible intensity and cohorts Control for uncertainty and cohorts Intercept –2.981 <0.001 −0.149 0.559 0.508 0.067 -0.477 0.060 Fiscal year × 1,000 0.015 <0.001 0.091 0.481 −0.141 0.284 0.000 0.052 R&D 0.389 0.033 COGS −0.279 <0.001 Product-launch years 0.133 <0.001 Special items 0.450 0.003 H-index 0.061 0.363 DummyListYear1970_79 0.145 <0.001 <0.001 0.001 0.679 0.014 <0.001 DummyListYear1980_89 0.070 <0.001 0.021 0.038 0.058 <0.001 DummyListYear1990_99 0.087 <0.001 0.025 0.049 0.061 <0.001 DummyListYear2000_09 0.102 <0.001 0.011 0.562 0.066 <0.001 N 135 135 135 140 F-value 26.46 185.92 161.14 169.90 Probability <0.001 <0.001 <0.001 <0.001 Adjusted R-squared 87.34% 89.38% 91.90% Average Pre-1970 < 1970s cohort (0< γ1) <0.001 0.679 <0.001 Average 1970s cohort < 1980s cohort (γ1< γ2) <0.001 0.014 <0.001 Average 1980s cohort < 1990s cohort (γ2<γ3) <0.001 0.383 0.416 Average 1990s cohort < 2000s cohort (γ3< γ4) 0.011 No 0.357 VI Tests of convergence of operating and financial characteristics across successive cohorts of listed firms
Appendix 1 - Chinese emotion dictionary (both in Chinese and in English by translation) 牛市(Bull market) 贷款(loan) 巨大(enormous) 暴涨(boom) 爆发() 天量(eye-popping amount of transaction volume) 火爆(Hot) 涨停板(rise to daily limit) 抵押(guaranty) 重仓(heavy holdings) 急升(steep rise) 狂热(fever) 火热(hit) 巨量(jillion) 冠全球(Global Crown) 烧(Burn) increase) 暴增() 牛气冲天(full of bull) 神话(myth) 狂欢(carnival) 政策牛(policy bull) profit) 火箭(rocket) 超级牛(super bull) 气势如虹(unstoppable) 如火如荼(in full swing) 奇迹( ) 狂牛(Mad cow) 傲视全球(the envy of the world) 升停板(up limit) 沸腾(ebullition) (33) (frequency ≥10)
Total= 33+50+86+92+51+43+26= 381 words Additional Categories: 泡沫(Bubble)： 泡沫(bubble) 危机(crisis) 金融危机(financial crisis) 破灭(disillusion) 破裂(rupture) 泡沫破裂(the rupture of the bubble) (8) 政府干预(Government Intervention)： 救市(bailout) 干预(intervene) Extra low frequency words: 国家队 (National Team) 护盘(support the market) 接盘(accept the offer) 官方资金(the official fund) 托市(when the market drop constantly, the authorities inject the fund into the market to make it rise again) (7) Table 1: Correlation matrix
Table 4: Degree Programme Portfolio % of programme delivered by core faculty Duration Year in which programme started Collaborative provision: Joint/ Franchised/ Validated/ No 1 Mode: Full time/ Part time/ Distance Learning/ Does the programme require previous work experience? Yes/No Primary language(s) of instruction No. of applicants this year No. offered a place this year No. of students enrolled this year Total No. of currently enrolled students in all years of the programme % of registered non-nationals (not including exchange students) No. of incoming exchange students this year No. of outgoing exchange students this year Bachelors Total Pre-Experience Masters Total Post-Experience Masters MBAs Total Doctoral Programmes Others GRAND TOTAL 1 Leave blank if non-collaborative delivery - If the School is engaged in collaborative provision, then Appendix 3 (Collaborative Provision) needs to be filled out as well.
Appendix 1: Research Output (last 24 months) Academic Research: List the names of academic journals and numbers of publications of the core faculty for the last 24 months. Journals should be ranked according to their relevance for the School (starting with 1 as the highest category). The same ranking number may be assigned repeatedly. Table 6: Academic Research Output Ranking Rank Journal Name No. of Pubs. Comment 1 2 … can be assigned to individual journals or journal groupings; publication numbers need to be provided for individual journals. Add rows as necessary. Use the Comment column to define rank categories further (optional). Practice-Oriented Research: Provide summary statistics describing the practice-oriented research of the core faculty for the last 24 months and that also reflect how the School evaluates its quality. Table 7: Practice-Oriented Research Output Classification Category No. of Pubs. Comment Categories represent unranked publication types as used by the School (e.g. books, case studies, newspaper articles, etc.) when recording practice-oriented research activity. Add rows as necessary. Use the Comment column to describe quality within each category; add additional text below this table to discuss quality across the entire portfolio of practice-oriented research. Appendix 2: Multi-Campus Operations (delete if not applicable) A campus is defined as a geographical location used for the regular and on-going delivery of degree or education even if the delivery itself takes place in temporary premises. Please refer to Annex 15 of the EQUIS Process Manual Annexes for further details on Multi-Campus Operations. Management and Oversight: Describe management systems as well as governance and quality assurance mechanisms established to manage the campus network (incl. coordination and resource sharing across campus locations). Campus Activities: For each campus location, fill out the table below by adding figures available for the last academic or calendar year (add tables as needed). Table 8a: <Name> (founded in: <Year>)* 1. Programmes 1.1. Degree Programmes Degree Designation Student FTE (total) Student FTE (last intake) % Non-Nationals Mobility
Question Please choose If yes please comment 5 Would you be interested in participating in EFMP recreational activities? 6 Do you plan to participate in the Respite Care Reimbursement Program? Housing Question Please choose If yes please comment 7 Will your family be requesting installation or Public Private Venture (PPV) housing? 8 Does your family qualify for priority housing? 9 Does your EFM require accommodations or modifications for housing? 10 Have you already applied for housing? 11 Do you have any pets? 12 Do you have any service animals? Travel Question Please choose If yes please comment 13 Do you have a calendar? “Plan my Move” can be found at: Medical Question Please choose If yes please comment 14 Are all medication prescriptions filled w/refills? 15 Do you have copies of your EFM’s medical records? 16 Have you transferred your ? 17 Have you transferred your Tricare and/or ECHO Case Manager? 18 Do you have the gaining location doctors established? 19 Will you need doctor appointments within 30 days of your arrival? School Question Please choose If yes please comment 20 Do you have a ecord (SCOR) notebook? SCOR can be found at:
Attending Faculty: Name_________________________________________________________________
Shitara, Kristen 27 5 # STUDENTS Exley, Shannon 24 Potter, Lindsey 27 Sperry, Monica 25 Sudol, Lisa 25 TOTALS # STUDENTS KINDER 63 GRADE 1 62 GRADE 2 70 GRADE 3 86 GRADE 4 81 GRADE 5 101 GRADE 6 86 GRADE 7 105 GRADE 8 88 GRAND TOTAL
Educational. Grantsville Elementary School has 220 students (kindergarten through fifth grade) with an average of 10.5 students per teacher. Of these students, 99% are Caucasian and 1% identify as two or more races. The third grade math scores were 87%, which is 1% below the state average and reading scores were 90%, which was 5% above the state average. Seventy-five percent of the students are eligible for free or reduced lunch (“Grantsville elementary,” 2013). Grantsville Elementary received a seven out of ten rating from “Great Schools” ("Grantsville elementary school," 2013). Middle and high school students travel by bus to Northern Middle and High School in Accident, Maryland, which is 15 miles from Grantsville. There are four colleges/universities less than 45 miles from Grantsville: Frostburg State University, Allegany College of Maryland, Garrett Community College (GCC) and West Virginia University (Grantsville, Maryland, 2013). GCC has a Northern Outreach Center in Grantsville that provides non-credit courses (Garrett Community College, 2013). Recreational. The town of Grantsville has a park consisting of several pavilions, a stage, four basketball courts, four tennis courts, two softball fields, an oval path for walking/running, two children’s playgrounds, and restroom facilities. This was noted during the windshield survey. The park is open year round, but is utilized by the community from May to August. During this time, the community hosts events such as concerts, Grantsville Days, the Western Maryland Truck Show, Farmer’s Market, and the circus (Directory, 2013). The town of Grantsville maintains the park (“Town of Grantsville, 2009). Grantsville Elementary is the only facility in the town of Grantsville that is available for indoor recreational activities. There is an athletic field at Grantsville Elementary School that can be used for sporting events (“Town of Grantsville, 2009).
Proposed change: ‘A documented risk assessment (e.g. manufacturing process risk and/or medical risk as appropriate) has been performed by, …’ Statement, part I 2nd paragraph Comment: The “Statement of Non-Compliance with GMP” is a mechanism for the exchange of information between National Competent Authorities of the EEA. With complex global supply chains there may be impact on the supply of critical medicines from the manufacturer to non-EEA countries. Proposed change: To avoid interruption of supply of critical medicines, add a second note. Note to issuing authorities: If the statement is shared with non-EEA authorities, the Manufacturing Authorisation Holder should be informed to facilitate a conversation regarding impact and critical supply in non-EEA markets. Statement, part I 2nd paragraph Comment: The receiving authorities shall contact the issuing authority within ‘20 working days’ in case there are critical medicinal products potentially affected by this statement. Proposed change: We recommend to change to 30 calendar days as working days are different per member state due to various bank holidays. Statement, part I 4th paragraph Comment: Companies could have a QP structure and not only one QP, and therefore it is important to be more precise. Proposed change: In exceptional circumstances there may be no objection to the Qualified Person in the scope of the non-compliance
inclusion in the Summary of Product Characteristics, in order to be consistent with guidance in Section 6.1. Lines 406-409 Comment: While the hierarchical test may be suitable when the order of hypotheses is easy to establish, it may be too strict for other situations, where more flexible procedures have clear advantages (e.g., Bonferroni-Holm, gatekeeping and graphical procedures). Thus it would be helpful to mention some well-established procedures which are also appropriate for multiplicity adjustments for primary and secondary endpoints. Proposed change: Delete the sentences in Lines 406-409: “However, more complex methods to control type I error over both primary and secondary endpoints, and these could be more useful in some circumstances. Depending on the degree of complexity, regulatory dialogue is recommended to assure that the outcome of the procedure can be interpreted in clinical terms.” Insert a new paragraph as follows after “…, reflects their relative importance in the study.”: “There are situations in practice where the hierarchical order is less clear among the secondary endpoints. In these cases, a hierarchical test may be too strict. Thus more flexible methods that do not impose a strict hierarchy may be preferred. These procedures are well established and usually have power advantages to reject at least one secondary hypothesis.” Lines 413-418 Comment: Please consider providing guidance and examples on assigning the clinically very important endpoint also as primary endpoint and adjust for multiplicity with the
During the Action, a Beneficiary may contribute additional data, know-how or information pursuant to Clause 6.1.4 of the Consortium Agreement that it lawfully acquires control of following the date it accedes to the Grant Agreement. Such additional data, know-how or information shall be identified in the chart below. ADDITIONAL DATA, KNOW-HOW or INFORMATION ENTERED INTO THE ACTION ITS START DATE. N° Beneficiary Owner (Beneficiary acronym) Data, information (with the exclusion of Materials) Type of data, information Beneficiary who access to the information Related WP or task Is there any legal restriction to the use of your data, know-how, information? [x] [company] [describe the additional data & information] [add type] [All ] [Benf. of WPx] [WP x] [describe third party limitations on use or other restrictions imposed by appl. law] Appendix 7: Data management plan (if applicable) Appendix 8: Contract under Mandate: One-sided CDA THIS IS A TEMPLATE CDA PROPOSED FOR THE [X] ACTION, WHOSE MEMBERS HAVE APPROVED THE SUBSTANTIVE PROVISIONS AND AUTHORISED ITS SIGNATURE ON THEIR BEHALF. ANY CHANGES THE SUBSTANCE SHOULD NOT BE WITHOUT APPROVAL, WHICH MAY CAUSE A DELAY. CONFIDENTIAL DISCLOSURE AGREEMENT (ONE WAY) THIS CONFIDENTIAL DISCLOSURE AGREEMENT (this “Agreement”) is made and entered into as of the [insert date] (the “Effective Date”), by and between:
data will likely result in a process that does not add value because of the potential high amount of cases that will be reported. For an issue occurring at a single investigator site for a single patient a Sponsor QMS root cause analysis and full-blown CAPA process do not make sense from a risk management perspective. The above approach negates the direction provided by ICH-GCP revision to have a risked based approach. Please clarify alignment with risk based approach as described in ICH E6 revision Specific comments on text Line number(s) of the relevant text (e.g. Lines 20-23) Stakeholder number (To be completed by the Agency) Comment and rationale; proposed changes (If changes to the wording are suggested, they should be highlighted using 'track changes') Outcome (To be completed by the Agency) §1 Legal Requirement Line 39 Comment: :” 2. For the purposes of this Article, a ‘serious breach’ means a breach likely to affect to a significant degree the safety and rights of a subject or the reliability and robustness of the data generated in the clinical trial.” Proposed change (if any): Would rather state it as serious breach if it did affect to a significant degree… (cfr App II initial assessment : line 213 : question is whether the breach does affect to a significant degree the safety of subject etc…)
Appendix I - 207 SAE reporting (page 11) “No, if this did not result in trial subjects being put at risk, and if it was not a systematic or persistent problem. In some circumstances, failure to report a SUSAR could have a significant impact on trial subjects. Sufficient information and context should be provided for the impact to be assessed adequately. “ It is understood that if one SUSAR is not reported this is not a serious breach because it was single event. This implies that there first needs to be a trend. Please clarify in which cases this would be a serious breach. Appendix 1 Category SAE reporting “The investigator was not clear on the reporting requirements for the and was incorrectly classifying events as expected” and then: “Yes, incorrect classification of seriousness criteria”. Comment: “seriousness” is independent of “expectedness”. The example speaks about expectedness, the response speaks about seriousness which is inconsistent. Errors from investigator sites on the assessment of events may occur, however investigators are not responsible for assessing expectedness which is based on the RSI as specified in the IB or approved label (SmPC). The pharmacovigilance department of the sponsor is responsible to evaluate the expectedness of an event against the RSI, and will then classify events as SUSARs when appropriate. Proposal: Example to be corrected and modified. “The investigator was not documenting all the AEs associated with the trial.”
5 January 2015 Submission of comments on 'Draft concept paper on the revision of the guideline on the development of new medicinal products for the treatment of ulcerative colitis’ – EMA/CHMP/327812/2014 Comments from: Name of organisation or individual – Sylvie Meillerais () Please note that comments and the identity of the sender will be published unless a specific justified objection is received. When completed, this form should be sent to the European Medicines Agency electronically, in Word format (not PDF). trial
145-9 Comment: Knowing that the database to be used is not defined in this guidance, we recommend to specify that search constructions should be revised and updated if needed, each time a thesaurus update is released. Proposed changes: Search constructions are routinely updated and maintained necessary to improve search precision and to align with any updates to the thesaurus used for indexing as well as to the substance groups as referred to in chapter 2.1. . Updates are announced in due time by the Agency. Search Criteria: Process clarity 158-161 EFPIA Comment: What methods will the EMA provider use for translation of articles? Are they validated? Where an article is in a foreign language, will the agency translate into English and make text available to MAH? Translation: Process clarity 166-167 EFPIA Comment: It is unclear what would be included in the search results that are published daily. By way of sample explain how this will differ from the published list of ICSRs entered into Eudravigilance as per lines 238-246. Proposed change: Suggest rewording “Search results based on the execution of scripts are made publicly accessible on a daily basis and will include the above referenced data to allow the MAHs to identify if any ICSRs for their products have been identified from the search”. Published Lists: Process clarity 166-167 EFPIA Comment: The outputs are provided in a tabular, format on the EudraVigilance restricted website. Who has access to this website to review these uploads on a daily basis, noting that many MAHs have Business arrangements Access: Process clarity for access to the restricted website.
General comments Stakeholder number (To be completed by the Agency) General comment (if any) Outcome (if applicable) (To be completed by the Agency) EFPIA welcomes the revised draft guidance document on the practical applications regarding the accelerated assessment (AA) procedure in particular the more detailed and revised timeline schedule. EFPIA particularly welcomes the clarification that products which are subject to a conditional marketing authorisation, should be eligible for an accelerated assessment following specific request by the applicant. On the procedural side, EFPIA is very supportive of the introduction of a second possibility to submit written responses without clock-stop. For the revision of the guideline the following aspects are of key importance which will be followed by detailed comments: Distribution of the Rapporteur’s assessment report (AR) is not provided for in the revised guideline. Inclusion of a step for timely provision to the applicant of the Rapporteur’s Assessment Report is critical in order to be prepared at Day 90 and to evaluate if a one-month clock stop can be maintained. Background: Under the current process applicants are provided the draft assessment reports at Day 80 which enables draft response
by the preparation of this Reflection Paper to further discuss and agree practical interpretations that ensure appropriate visibility of product quality data with minimal duplication of effort between manufacturing sites, the QPs at these sites, Regulatory functions and the various legal entities that constitute the ‘Marketing Authorisation Holder’ in order to find the best format for joint Product Quality Reviews between all parties. For example, Chapter 1 requires a Product Quality Review (PQR) to take into account the ‘qualification status of relevant equipment and utilities, e.g. HVAC, water, compressed gases, etc.’ which is an aspect of the PQR which the MAH would not typically be equipped to assess. Conversely, the review of ‘Marketing Authorisation variations submitted, granted or refused’ is a key element of PQR which MAHs should be responsible for reviewing. Consistent interpretation across the EU of accountability of all parties involved in PQRs would be welcomed. It is noted that amongst the areas that are not considered to be well addressed at present are the provision of the necessary registered details, the management of MA variations, and regulatory commitments to manufacturing sites. Given the work currently being undertaken on ICH Q12 and the expectation that this will result in greater flexibility in post-approval lifecycle change management, it might be appropriate to include specialists undertaking EMA MAA assessments in the drafting group as well as GMP inspectors. Building upon the point above regarding Q12, and the increasing global collaboration amongst agencies on GMP (with e.g. the EU/US Mutual Recognition Agreement in progress) triggers the need for a robust and transparent EU inspection process with clear roles & responsibilities for all parties due to the major impact decisions on GMP status can have on global supply chains. Thus, the scope of the Reflection Paper should be expanded to include consideration of how the MAH can interact with the supervisory GMP authority inspecting the manufacturing site, specifically in the case of critical findings which might trigger a change in the GMP status of the supplying site.
Line 96 Comment: The rules of procedure indicate that information on how to submit written contributions will be included with the announcement of the public hearing. We recognise that certain specific aspects of the hearing cannot be addressed until a decision has been taken to hold a public hearing. It would, however, be helpful to provide some general guidance on the EMA website to aid with the timely preparation of written contributions (e.g. format, general points to consider), especially given the likely short period between the announcement and the deadline for submissions. Line 99 Comment: Live broadcast/web stream should not be optional unless integral meeting video/audio/minutes are shortly available after the public hearing in order to provide equal opportunity of information to the public. Line 105 Comment: Members of the public will need to understand whether their contribution in person or via telephone will be reimbursed or at their own expense. This should be clarified in this section. Lines 106 Comment: members of the public may not understand the term “teleconference” or understand/have access to Adobe Connect and therefore may need support with this. Proposed change: “Speakers can make an intervention in person or via telephone (e.g. teleconferencing using facilities such as Adobe Connect) where possible and feasible.” Line 114 Proposed change: “Requesters will receive a confirmation of their request in advance at least 2 calendar weeks ahead of the hearing” Lines 115-116 Comment: See comment line 99. Lines 123-132 Comment: When appropriate, speakers should reference or detail the data source as well as the methodology used for the analysis, in compliance with relevant quality standards for
Costs for users EFRAG has carried out an initial assessment of the cost implications for users resulting from the Amendments. Overall, initial assessment is that the Amendments, in general, will not result in significant increased costs to users. Still, when an entity opts to change from ‘cost’ or ‘fair value’ to ‘equity method’ and applies that change retrospectively, users are likely to incur some costs related to updating analyses or databases for comparative information. Users will also have to assess the impact of that change on the financial performance and position of the company. Those users, if any, who prefer to restate the amounts included in each category of investment with the objective of obtaining information in a ‘comparable format’ may have to incur additional ongoing costs as a result of the introduction of an additional accounting policy option. Benefits for preparers and users EFRAG has carried out an initial assessment of the benefits for users and preparers resulting from the Amendments EFRAG’s initial assessment is that the Amendments will not result in significant benefits for all preparers, i.e., it is likely to be neutral for many preparers. However, EFRAG acknowledges that preparers might choose to use the equity method to account for investments in subsidiaries, joint ventures and associates in the separate financial statements when they expect benefits from using that option (e.g. for local compliance purposes) to exceed the costs. Users are likely to benefit from an accounting policy option that allows the incorporation, over time, of the results of an investee into the investor’s financial statements. Consequently, the use of the equity method provides timely, relevant and reliable information about the investment’s performance and economic value to users of separate financial statements. Overall, EFRAG’s initial assessment is that users are likely to benefit from the Amendments, despite the decreased comparability induced by the accounting policy options, as the information resulting from the Amendments will provide relevant and reliable information about the investment’s performance and economic value. Conclusion EFRAG’s overall initial assessment is that the benefits of the Amendments are likely to outweigh the costs associated with them. Appendix 4 Dissenting opinions One EFRAG TEG member dissents from recommending the endorsement of the Amendments. Due to the recent reform, EFRAG Board will be responsible for all EFRAG positions after considering the technical advice provided by the EFRAG Technical Expert Group and the outcome of EFRAG’s due process. Therefore, any views dissenting
EMERGENCY FOOD AND SHELTER PROGRAM (EFSP) OF BROWARD COUNTY PHASE XXXV FUNDING APPLICATION 15 A- FINANCIAL INFORMATION PROGRAM Budget (EFSP Request ) Organization Name: Address, City & Zip Code: Agency Fiscal Year Begins Contact Person: Telephone: Fax: E-mail: AGENCY'S TOTAL ANNUAL BUDGET FOR 2018 $ ________________________ BUDGET FOR YOUR "EFSP" FUNDING REQUEST $ ________________________ PROGRAM BUDGET (Funding Request Categories) Categories for Funding Type of Service Provided Units of Service to be Provided with EFSP Funding Clients to be Served w/EFSP Funds (Estimate) EFSP Funding Request Non-EFSP Program Budget Total Program Budget EFSP + Non EFSP Example Only: Requested Grant Amount for Program Eg. Meals 3,000 3,000 $6,000 $40,000 $46,000 A. Mass Feeding Program ($2 per meal served) Meals B. Food Pantry Operations Meals C. Food Vouchers Food Vouchers D. Mass Shelter $12.50 Per diem per day Bed Nights E. Hotel/Motel Bed Nights F. Rent/Mortgage Assistance Payment (average $$ assistance) TOTAL EFSP FUNDING REQUESTED $_______________ $_______________ $______________________ *See attached example*
QUESTIONS FOR AGENCIES REQUESTING EFSP FUNDS FOR MEAL PROGRAMS • Please provide the information whether or not you received EFSP funding previously. • Confine your answers to the space provided, and provide information only on programs eligible for EFSP funding. 1. How many people did you serve? (5) 2015-16 2016-17 2017-18 2. Please describe typical meals you provide. Is your facility licensed by the Health Department? If not, why not, and what health and safety measures do you maintain? (20) QUESTIONS FOR AGENCIES REQUESTING EFSP FUNDS FOR SHELTER PROGRAMS • Please provide the information whether or not you received EFSP funding previously. • Confine your answers to the space provided, and provide information only on programs eligible for EFSP funding. 1. What is your shelter capacity? __________________ 2. How many nights was your shelter open in each of the last three years? (5) 2015-16 2016-17 2017-18 3. How long can an individual stay in your shelter and what happens when he/she leaves? (20)
Admin. Assistant IV Orlinda Del Toro 720.944.1431 Financial DHS Paul Cavender 720.944.1576 Paul.Cavender@denvergov.org Financial OED Barbara Callison 720.913.1722 FAD Liaison Loretta Leichtle 720.944.2711 Denver County Employment First 3815 Steele Street Denver, CO 80205 Phone: 720.944.5641 Fax: 720.944.5640 EF Supervisor Tanya Davis 720.944.5576 Sr. Workforce Advisor Holbrook 720.944.5566 Case Manager Sondra Tribble 720.944.5571 Case Manager Marlyne Aguilar 720.944.5567 Workfare Coordinator Shane Hickman 720.944.5569 Admin. Assistant IV Alicia Trujillo 720.944.5574 Assistant II Eva Nelson 720.944.5568 Christina Gallegos 720.944.5567 denise.gallegos@denvergov.org El Paso County Employment First Goodwill Industries 1675 Garden of the Gods Road Colorado Springs, CO 80907 Phone: 719.444.5930 Fax: 719.444.8353 Director Skolasinski 719.444.5041 EF Manager Jennifer Bailey 719.373.3217 Program Coordinator Nathan Kimbro 719.444.5819 Job Developer Michele Bradley 719.444.5837 Case Manager Konnstance 719.444.5833 Case Manager Evelyn Bonilla 719.644.8410 Case Manager Keely Flores 719.429.3323
nnaire asking the participant to complete: Consent form Profile information form (age, gender, ethnicity etc.) ve them ‘WEMWBS 1’ to complete. Stage 2: and/or end of project and ask the to te ‘WEMWBS 2’ statements. Check the project number and ID are on the questionnaire if this hasn’t already been done. Afterwards, Store WEMWBS 2 in the participants corresponding envelope. Get par comple number 3: Final ticipant may be to the final nnaire either at the end of the project Afterwards, Store WEMWBS 3 in the participants corresponding envelope, with the first and second forms. the same project number and ID number The par questio the end needs t I t
Outputs Component 1 Industial Mapping and development of inventory Output 1.1 Output 1.2 Component 2 Policy Advocacy Output 2 Component 3 Awareness and Capacity building Output 3.1 Output 3.2 Component 4: Green Entrepreneurship Devt Program Output 4 Component 5: Project Mgmt Surveys and evidence based analysis Analysis in one zone Inventory in one zone Policy Briefs Awareness campaign Capacities built Jobs created 0 0 0 No known demand 0 4 2 3 Utilization of IWEX system Green entrepreneurship programme established 50 direct and 150 indirect Project Reports Project Reports Project Reports Project Reports Key activities components Inputs Component 1 : Evidence-based information and setting up of inventory Component 2: Policy Advocacy Component 3: Capacity building Component 4: Demo projects Component 5: Project management Component 1: Studies and surveys Component 2: Consultations Component 3: Trainings, consultants, study tours Component 4: resources
Purpose of the project : Support the development and integration of unplanned in clusters, within the value-chain so as to create employment and increase competitiveness of the economy. Results chain Performance indicators of verification Risks/mitigation measures Indicator (including CSI) Baseline Target Impact Impact Regulation and laws adopted by government related to integration of organic cluster in the development plans No regulations exist Policy options developed Project Completion Report Outcomes Outcome 1 Employment opportunities (disaggregated by gender and Rate of unemployment 13% Female : 20% Youth : 25% 12.4% Project Completion Report Detrioration of context in Egypt increases unemployment/ the Bank, the IMF and other Development Partners have confirmed their support to finance the budget deficit. Organic MSMEs uninterested in formalizing/ BDS support provided is not conditional upon formalization of the organic MSMEs, however awareness raising on the benefits of formalization will also be conducted. Outcome 2 Increase contribution to manufacturing value-addition by organic MSME clusters % 0 50%
Outputs Component 1 Policy Advocacy Output 1.1 Output 1.2 Component 2 Institutional capacity Output 2.1 Output 2.2 Component 3 Pilot project Output 3.1 Output 3.2 Evidence based studies Policy briefs Trained stakeholders Introduce cluster management system Action plan Increase in demand for services by MSMEs 0 0 0 No No plan No known demand 4 2 50 Study Plan implemented 50 % increase Project Reports Project Reports Project Reports Project Reports Project Reports Project Reports Key activities components Inputs Component 1 Capacity building Component 2 Policy Advocacy Component 1 Resources Component 2 Evidence based studies Annex – Procurement of Activities under the Project
Project Financing Lending Instrument This technical assistance project will be financed by a from the MENA Transition Fund in the amount of US$ 6.5 million. The grant will be recipient executed in accordance with applicable World Bank and the MENA Transition Fund policies and procedures. Project Cost and Financing Indicative project and financing per components are: Project Components Project cost MENA Transition Fund Financing % Financing (including Power Sector Institutional Development and Financial Viability Electricity Utilities Financial Management and Governance Fuel to Power Strategy Establishment of an Energy Efficiency Unit at the Ministry of Electricity and Energy Implementation support to the PMT Energy Pricing and Fuel Switching Reform Technical Assistance Energy Pricing and Fuel Switching Reform Strategy Development of a Communication strategy for Fuel Reform Strengthening Social Safety Nets Technical Assistance Support to establishment of the database of the poor Baseline Survey on SSN Service Delivery Establishment of Technical Working Unit to Support SSN Reform 2.7 1.25 0.75 0.5 0.2 1.8 1.5 0.3 2.0 1.1 0.5 0.4 2.7 1.25 0.75 0.5 0.2 1.8 1.5 0.3 2.0 1.1 0.5 0.4 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100% 100%
Annex 1: Results Framework and Monitoring . Country: Egypt, Arab Rep Project Name: EGYPT Energy/Social Safety Nets Sector Reforms Technical Assistance (P144305) . Results Framework . Project Development Objectives . PDO Statement The proposed project will strengthen the Government of Egypt’s capacity to (i) design a comprehensive fuel subsidy reform strategy, (ii) establish concrete measures for improved financial viability of key energy sector actors and (iii) identify households that would be most vulnerable to the impacts of the fuel subsidy reform.. . Project Development Objective Indicators Cumulative Target Values Data Source/ Responsibility for Indicator Name Core Unit of Measure Baseline YR1 YR2 End Target Frequency Methodology Data Collection Direct project beneficiaries (number), of which female (percentage) number None TBD TBD TBD Progress Reports, Supervision Reports PMT, and Bank Team An action plan to improve the financial viability and governance of EEHC is prepared Text None None Draft action plan is developed. Action Plan is finalized Progress Reports, Supervision Reports PMT, and World Bank Team Semi- Annually Semi- Annually
Executive Summary The accumulation of decent housing matters both because of the difference it makes to living standards and because of its centrality to economic development (shared prosperity). In addition to directly providing shelter, decent housing improves health and facilitates educational achievement. A home and its environs affect identity and self-respect. Egypt has made strides in improving access to basic services, one of the most important components of living standards related to housing The World Bank has approved the “Inclusive Housing Finance Program” on May 5, 2015, which is US$ 500 million Program-for-Results loan to the GoE. The Program aims at improving the affordability of formal housing for low-income households in Egypt and to strengthen the Social Housing Fund's capacity to design policies and coordinate programs in the social housing sector. The program will provide demand side subsidy for end beneficiaries for both home ownership and rent. The proposed activity will complement this Program through providing technical assistance to SHF and other relevant entities within the GoE to build the institutional capacity of the SHF and strengthen its ability of the SHF to define sound policies. This activity will also promote private sector engagement in social housing.
Annex 1: Results Framework Project Development Objective (PDO): The objectives of the project are to finalize a sound institutional set-up for the SHF and to equip SHF with policy tools to develop its capacity to prepare a housing strategy, which would include steps to ensure private sector engagement. PDO Results Indicators* Unit of Measure Baseline Cumulative Target Values** Frequency Data Source/ Methodology Responsibility for Data Collection Description (indicator definition etc.) YR 1 YR 2 YR3 Indicator one: New Housing Strategy Yes/No No No No Yes Annual SHF SHF/WB Indicator Two: Establishment and operation of SHF internal Units and mechanisms Yes/No No Yes Yes Yes Annual SHF SHF/WB SHF to have a functioning internal audit unit, M&E unit, accountability and transparency mechanism and occupancy and vacancy monitoring mechanism Indicator Three: Reaching a PPP agreement for private sector engagement Yes/No No Yes Yes Yes Annual WB/SHF SHF/WB Reaching a workable model to engage the private sector in social housing Indicator Four: Developing public rent model Yes/No No Yes Yes Yes Annual WB/SHF SHF/WB Developing the public rent component to low income households Indicator Five: Developing and updating Housing Price Index Yes/No No no Yes Yes Annual SHF WB Developing and continuously updating HPI INTERMEDIATE RESULTS Intermediate Result (Component One): Developing a new housing strategy Intermediate Result (Component One): Developing a new housing strategy Yes/No No No No Yes Annual WB/SHF SHF/WB Intermediate Result indicator One: organization of a workshop on Housing Strategy Yes/No No No Yes Yes Annual WB/SHF SHF/WB Intermediate Result (Component Two): Institutional Set-up of SHF Intermediate Result indicator One: Establishment and operation of an Internal Audit Unit Yes/No No Yes Yes Yes Annual SHF WB
Essential criteria Knowledge A comprehensive understanding of the challenges facing higher education and of the relative importance of research impact within that landscape. Detailed knowledge and understanding of the policy and funding environment governing the management of university research impact – in particular of the Research Excellence Framework. Excellent communication and negotiation skills, including a proven ability to set out a clear and compelling business case, verbally and in writing, to a variety of audiences. A, I A, I, E A, I, E Qualifications A good honours degree or higher education qualification or equivalent experience demonstrating high analytical, communication and analytical skills A Experience Strong track record of initiating and delivering successful innovative, pan-institutional initiatives in a large organisation – preferably in higher education and of working across disciplines. Previous experience of working on managing research impact in an HE, or complex policy environment Proven ability to manage and motivate people and to deliver strong outcomes in a matrix management environment. Experience of project management in higher education or elsewhere which demonstrates the ability to ensure that all planned activity is properly monitored and accounted for and that deadlines are met within the agreed budget. Experience of identifying and negotiating change successfully across large organisations Experience of designing and delivering training to an academic and non-academic audience Ability to produce a convincing evidence-based case for change. A, I A, I A, I A, I A, I A, I A, I Salary range: £42418 to £49149. The appointment is generally made at the bottom of the range dependent upon experience and previous salary. The annual leave entitlement is 27 days per annum, plus public holidays and University closure days. Annual leave, including public holidays and closure days, is pro-rated for part-time staff. Hours – 37 hours per week More information about the department can be found The University has an attractive range of benefits and you can find more information about them on our website.