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E2d POST-APPROVAL SAFETY DATA MANAGEMENT DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

E2d POST-APPROVAL SAFETY DATA MANAGEMENT  DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING
E2d POST-APPROVAL SAFETY DATA MANAGEMENT  DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

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POST-APPROVAL SAFETY DATA MANAGEMENT: DEFINITIONS AND STANDARDS FOR EXPEDITED REPORTING

ICH Harmonised Tripartite Guideline draft

Recommended for Adoption

at Step 2 of the ICH Process

on July 18, 2003

by the ICH Steering Committee

This draft guidance, when finalized, will represent the Food and Drug Administration's (FDA's) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the appropriate number listed on the title page of this guidance.

ICH E2D ver 3.8

37 38 39 40 41 42 43 44 45 46 47 48 49 50 51 52 53 54 55 56 57 58 59 60 61 62 63 64 65 66 67 68 69 70 71 72 73 74 75 76 77 78 79 80 81Table of Contents

1. INTRODUCTION

2. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH POST-

APPROVAL DRUG SAFETY EXPERIENCE

2.1. Basic Terms

2.1.1. Adverse Event (or Adverse Experience)

2.1.2. Adverse Drug Reaction (ADR)

2.2. Seriousness Criteria

2.3. Unexpected Adverse Drug Reactions

2.4. Other Definitions

2.4.1. Healthcare Professionals

2.4.2. Consumers

2.5. Sources of Individual Case Reports

2.5.1. Unsolicited Sources

2.5.1.1. Spontaneous Reports

2.5.1.1.1. Consumer Reports

2.5.1.2. Literature

2.5.1.

3. Internet

2.5.1.4. Other Sources

2.5.2. Solicited Sources

2.5.

3. Licensor-Licensee Interaction

2.5.4. Regulatory Authority Sources

3. STANDARDS FOR EXPEDITED REPORTING

3.1. What Should Be Reported?

3.1.1. Single Cases of Serious ADRs

3.1.2. Reporting Guidelines for Other Observations

3.1.2.1. Lack of Efficacy

3.1.2.2. Overdose

3.2. Reporting Time Frames

3.2.1. Minimum Criteria for Reporting

3.2.2. Time Clock Start Point

3.2.3. Non-serious ADRs

4. GOOD CASE MANAGEMENT PRACTICE

4.1. Assessing Patient and Reporter Identifiability

4.2. The Role of the Narratives

4.3. Single Case Evaluation

4.4. Follow-up Information

4.4.1. Follow-up Related to Pregnancy Exposure

4.5. How to Report

Reference Sources

Attachment

1. INTRODUCTION It is important to establish an internationally standardized procedure in order to improve the quality of post-approval safety information and to harmonise the way to gather and report information. ICH E2A provides guidance on pre-approval safety data management. Although many stakeholders have applied these E2A concepts to the post-approval phase, there is a need to provide further guidance on the definitions and standards for post-approval expedited reporting. This guideline is based on the content of ICH E2A with consideration as to how the terms and definitions can be applied in the post-approval phase of the product life cycle.

2. DEFINITIONS AND TERMINOLOGY ASSOCIATED WITH POST-APPROVAL DRUG SAFETY EXPERIENCE 2.1. Basic Terms 2.1.1. Adverse Event (or Adverse Experience) An adverse event (AE) is any untoward medical occurrence in a patient administered a medicinal product and which does not necessarily have to have a causal relationship with this treatment. An adverse event can therefore be any unfavorable and unintended sign (for example, an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal product, whether or not considered related to this medicinal product. 2.1.2. Adverse Drug Reaction (ADR) All noxious and unintended responses to a medicinal product related to any dose should be considered adverse drug reactions. The phrase “responses to a medicinal product” means that a causal relationship between a medicinal product and an adverse event is at least a possibility (refer to ICH E2A). A reaction, in contrast to an event, is characterized by the fact that a causal relationship between the drug and the occurrence is suspected. If an event is spontaneously reported, even if the relationship is unknown or unstated, it meets the definition of an adverse drug reaction. 2.2. Seriousness Criteria The most internationally agreed seriousness criteria appear in ICH guideline E2A. A serious adverse event (experience) or reaction is any untoward medical occurrence that at any dose: * results in death * is life-threatening (NOTE: The term “life-threatening” in the definition of “serious” refers to an event/a reaction in which the patient was at risk of death at the time of the event/reaction; it does not refer to an event/a reaction which hypothetically might have caused death if it were more severe), * requires inpatient hospitalisation or results in prolongation of existing hospitalisation, * results in persistent or significant disability/incapacity,

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?

?

?

* is a congenital anomaly/birth defect,

* is a medically important event or reaction.

Medical and scientific judgment should be exercised in deciding whether other

situations should be considered as serious such as important medical events

that may not be immediately life-threatening or result in death or

hospitalisation but may jeopardise the patient or may require intervention to

prevent one of the other outcomes listed in the definition above. These should

also be considered serious.

Examples of such events are intensive treatment in an emergency room or at

home for allergic bronchospasm; blood dyscrasias or convulsions that do not

result in hospitalisation; or development of drug dependency or drug abuse.

2.3. Unexpected Adverse Drug Reactions

An ADR whose nature, severity, specificity, or outcome is not consistent with the term or description used in the official product information should be considered unexpected.

An ADR with a fatal outcome should be considered unexpected, unless the official product information specifies a fatal outcome for the ADR. In the absence of special circumstances, once the fatal outcome is itself expected, reports involving fatal outcomes should be handled as for any other serious expected ADR in accord with appropriate regulatory requirements.

Please note that the term “listedness” is not applicable for expedited reporting (refer to ICH E2C for definition).

Additional considerations:

“Class ADRs” should not automatically be considered to be expected for the subject drug. “Class ADRs” should be considered to be expected only if described as specifically occurring with the product in the official product information, as illustrated in the following examples:

“As with other drugs of this class, the following undesirable effect occurs with Drug X.”

Drugs of this class, including Drug X, can cause...”

If the ADR has not been documented with Drug X, statements such as the following are likely to appear in the official product information:

“Other drugs of this class are reported to cause…”

“Drugs of this class are reported to cause..., but no reports have been received to date with Drug X.”.

In these situations, the ADR should not be considered as expected for Drug X.

In the absence of sufficient documentation and in the face of uncertainty, a reaction should be regarded as unexpected.

2.4. Other Definitions

175 176 177 178 179 180 181 182 183 184 185 186 187 188 189 190 191 192 193 194 195 196 197 198 199 200 201 202 203 204 205 206 207 208 209 210 211 212 213 214 215 216 217 218 219 220 221 2.4.1. Healthcare Professionals

Healthcare professionals are medically-qualified persons such as physicians, dentists, pharmacists, nurses, coroners, or as otherwise specified by local regulations. Preferably, information about the case should be collected from the healthcare professionals who are directly involved in the patient’s care. In some regions, the healthcare professional status of the reporter is immaterial to reporting practices.

2.4.2. Consumers

A consumer is defined as a person who is not a healthcare professional.

2.5. Sources of Individual Case Reports

2.5.1. Unsolicited Sources

2.5.1.1. Spontaneous Reports

A spontaneous report is an unsolicited communication by healthcare professionals or consumers to a company, regulatory authority or other organization (e.g. WHO, Regional Centers, Poison Control Center) that describes one or more adverse drug reactions in a patient who was given one or more medicinal products and that does not derive from a study or any organized data collection scheme.

Stimulated reporting may occur in certain situations, such as a notification by a “Dear Healthcare Professional” letter, a publication in the press, or questioning of healthcare professionals by company representatives. These reports should be considered spontaneous.

2.5.1.1.1. Consumer reports

Consumer adverse reaction reports should be handled as spontaneous reports irrespective of any subsequent “medical confirmation”, a process required by some authorities for reportab i lity. Even if reports received from consumers do not qualify for regulatory reporting, the cases should be retained. Emphasis should be placed on the quality of the report and not on its source.

2.5.1.2. Literature

The Marketing Authorisation Holder (MAH) is expected to regularly screen the worldwide scientific literature, by accessing widely used systematic literature reviews or reference databases. Cases of ADRs from the scientific and medical literature, including relevant published abstracts from meetings and draft manuscripts, might qualify for expedited reporting. D A regulatory reporting form with relevant medical information should be provided for each identifiable patient. The publication reference(s) should be given as the report source; additionally a copy of the article might be requested D by the local regulatory authority to accompany the report. All company offices are encouraged to be aware of publications in their local journals and to bring them to the attention of the company safety department as appropriate.

The regulatory reporting time clock starts once it is determined that the case meets minimum criteria for reportability. MAHs should search the literature according to local regulation or at least once a month. If the product source, brand, or trade name is not specified, the MAH should assume that it was its product, although reports should

222 223 224 225 226 227 228 229 230 231 232 233 234 235 236 237 238 239 240 241 242 243 244 245 246 247 248 249 250 251 252 253 254 255 256 257 258 259 260 261 262 263 264 265 266 267 indicate that the specific brand was not identified.

2.5.1.3 Internet

MAHs are not expected to screen external websites for ADR information. However, if an MAH becomes aware of an adverse reaction on a website that it does not manage, the MAH should review the adverse reaction and determine whether it should be reported. Unsolicited cases from the Internet should be handled as spontaneous reports. MAHs should regularly screen their websites for potential ADR case reports. MAHs and regulators should consider utilising their websites to facilitate ADR data collection, e.g. by providing ADR forms for direct reporting or by providing appropriate contact details for direct communication. For the determination of reportability the same criteria should be applied as for cases provided via other ways.

2.5.1.4 Other Sources

If MAHs become aware of a case report from non-medical sources, it should be handled as a spontaneous report.

2.5.2. Solicited Sources

Solicited reports are those derived from organized data collection systems, which include clinical trials, post-approval named patient use programs, other patient support and disease management programs, surveys of patients or healthcare providers, or information gathering on efficacy or patient compliance. Adverse event reports obtained from any of these should not be considered spontaneous.

For the purposes of safety reporting, solicited reports should be handled as if they were study reports, and therefore should have an appropriate causality assessment. Further guidance on study-related issues such as managing blinded therapy cases can be found in ICH E2A.

2.5.

3. Licensor-Licensee Interaction

When companies co-develop, co-market, or co-promote products, it is considered very important that explicit contractual agreements specify the processes for exchange of safety information, including timelines and regulatory reporting responsibilities. Whatever the contractual arrangement, the MAH is ultimately responsible for regulatory reporting.

It is particularly important to ensure that processes are in place to avoid duplicate reporting to the regulatory authority, e.g. assigning responsibility to one company for literature screening. The time frame for expedited regulatory reporting should normally be no longer than 15 calendar days from the first receipt of a case meeting minimum criteria by any of the partners, unless otherwise specified by local regulation. Any subsequent follow-up information sent to the regulators should be submitted by the same MAH that reported the case originally.

268 269 270 271 272 273 274 275 276 277 278 279 280 281 282 283 284 285 286 287 288 289 290 291 292 293 294 295 296 297 298 299 300 301 302 303 304 305 306 307 308 309 310 311 312 313 314 2.5.4. Regulatory Authority Sources

Individual serious unexpected adverse drug reaction reports originating from foreign regulatory authorities are always subject to [F1]expedited reporting. Re-submission of serious ADR cases without new information to the originating regulatory authority is not usually required, unless otherwise specified by local regulation.

3. STANDARDS FOR EXPEDITED REPORTING

3.1. What Should Be Reported?

3.1.1. Single Cases of Serious ADRs

Cases of adverse drug reactions from all sources that are both serious and unexpected are subject to expedited reporting. The reporting of serious expected reactions in an expedited manner varies among countries. Non-serious adverse reactions, whether expected or not, would normally not be subject to expedited reporting.

For reports from studies and other solicited sources, all cases judged by either the reporting healthcare professional or the MAH as having a possible causal relationship to the medicinal product qualify as ADRs. For the purposes of reporting, spontaneous reports associated with approved drugs imply a possible causality.

3.1.2. Reporting Guidelines for Other Observations

In addition to single case reports, any safety information from other observations that could change the risk-benefit evaluation for the product should be promptly communicated to the regulatory authorities.

3.1.2.1. Lack of Efficacy

Reports of lack of efficacy should not normally be expedited, but should be discussed in the relevant periodic safety update report. However, in certain circumstances reports of lack of efficacy should be treated as expedited cases for reporting purposes. Medicinal products used for the treatment of life-threatening or serious diseases, vaccines, and contraceptives are examples of classes of medicinal products where lack of efficacy should be considered for expedited reporting. Clinical judgment should be used in reporting, with consideration of the approved product labeling/prescribing information.

3.1.2.2 Overdose

Reports of overdose with no associated adverse outcome should not be reported as adverse reactions. They should be routinely followed up to ensure that information is as complete as possible with regard to symptoms, treatment, and outcome. The MAH should collect any available information related to its products on overdose, and report cases of these that lead to serious adverse reactions according to expedited reporting criteria.

3.2. Reporting Time Frames

In general, expedited reporting of serious and unexpected ADRs refers to 15 calendar days. Time frames for other types of reports vary among countries.

3.2.1.Minimum Criteria for Reporting

Minimum required data elements for an ADR case are: an identifiable reporter, an identifiable patient, an adverse reaction, and a suspect product. Lack of any of these

315 316 317 318 319 320 321 322 323 324 325 326 327 328 329 330 331 332 333 334 335 336 337 338 339 340 341 342 343 344 345 346 347 348 349 350 351 352 353 354 355 356 357 358 359 360 361 four elements means that the case is incomplete; however, MAHs are expected to exercise due diligence to collect the missing data elements. It is recommended that as much information as possible be collected at the time of the initial first report.

3.2.2. Time Clock Start Point

The regulatory reporting time clock (in calendar days) starts on the date when any personnel of the MAH first receive a case report that fulfills minimum criteria as well as the criteria for expedited reporting. In general, this date should be considered as day 0. When additional medically significant information is received for a previously reported case, the regulatory reporting time clock begins again for submission of the follow-up report.

3.2.3 Non-serious ADRs

Cases of non-serious ADRs are not normally reportable on an expedited basis. The spontaneous reports of non-serious ADRs should be reported in the periodic safety update report.

4. GOOD CASE MANAGEMENT PRACTICE

Accurate, complete and bona fide information is very important for MAHs and regulatory agencies identifying and assessing ADR reports. Both are faced with the task of acquiring sufficient information to help ensure that the reports are authentic, accurate, as complete as possible, and non-duplicative.

4.1. Assessing Patient and Reporter Identifiability

Patient and reporter identifiability is necessary to avoid case duplication, detect fraud, and facilitate follow-up of appropriate cases. The term identifiable in this context refers to the verification of the existence of a patient and a reporter.

One or more of the following automatically qualifies a patient as identifiable: age (or age category, e.g., adolescent, adult, elderly), gender, initials, date of birth, name, or patient identification number. Additionally, in the event of second-hand reports, every effort should be made to verify the report source. All parties supplying case information (or approached for case information) are subject to the notion of identifiability: not only the initial reporter (the initial contact for the case), but also others supplying information.

In the absence of qualifying descriptors, a report referring to a definite number of patients should not be regarded as a case until the minimum four criteria for case reporting are met. For example, “Two patients experienced…” or “ a few patients experienced” should be followed up for patient-identifiable information before regulatory reporting.

4.2. The Role of the Narratives

The objective of the narrative is to summarize all relevant clinical and related information, including patient characteristics, therapy details, medical history, clinical course of the event(s), diagnosis, and ADR(s) (including the outcome, laboratory evidence and any other information that supports or refutes an ADR). The narrative

362 363 364 365 366 367 368 369 370 371 372 373 374 375 376 377 378 379 380 381 382 383 384 385 386 387 388 389 390 391 392 393 394 395 396 397 398 399 400 401 402 403 404 405 406 407 408 should serve as a comprehensive, stand-alone “medical story”. The information should

be presented in a logical time sequence; ideally this should be presented in the

chronology of the patient’s experience, rather than in the chronology in which the

information was received. In follow-up reports, new information should be clearly

identified.

Abbreviations and acronyms should be avoided, with the possible exception of

laboratory parameters and units. Key information from supplementary records should

be included in the report, and their availability should be mentioned in the narrative and

supplied on request. Any autopsy or other post-mortem findings (including a coroner’s

report) should also be provided when available if allowed by local privacy protection

laws. Terms in the narrative should be accurately reflected by appropriate coding.

4.3. Single Case Evaluation

The purpose of careful medical review is to ensure correct interpretation of medical information. Regardless of the source of an ADR report, the recipient D should

carefully review the report for the quality and completeness of the medical information.

This should include, but is not limited to, consideration of the following: ?Is a diagnosis possible?

?Have the relevant diagnostic procedures been performed?

?Were alternative causes of the reaction(s) considered?

?What additional information is needed?

diagnosis. The report should include the verbatim term, which quotes the reporter.

Staff receiving reports should provide an unbiased and unfiltered report of the ADR terms should be used consistently and in accord with recommended standards for information from the reporter. While the report recipient is encouraged to actively

query the reporter to elicit the most complete account possible, inferences and

imputations should be avoided in report submission. However, clearly identified

evaluations by the MAH are considered acceptable and, for some authorities, required.

Encouraging good communication on medical information with the reporter will serve

to improve the quality of case documentation.

When a case is reported by a consumer, his/her description of the event should be

retained, although confirmatory or additional information from any relevant healthcare

professionals should also be sought and included. Ideally, supplemental information

should be obtained from the healthcare professional directly involved in the care of the

patient.

4.4. Follow-up Information

The information from ADR cases when first received is generally incomplete. Ideally,

comprehensive information would be available on all cases, but in practice efforts

should be made to seek additional information on selected reports (see Attachment). In

any scheme to optimize the value of follow-up, the first consideration should be

prioritization of case reports by importance.

The priority for follow-up should be as follows: cases which are 1) both serious and

unexpected, 2) serious and expected, and 3) non-serious and unexpected. In addition to

seriousness and expectedness as criteria, cases “of special interest” also deserve extra

attention as a high priority (e.g., ADRs under active surveillance at the request of the

409 410 411 412 413 414 415 416 417 418 419 420 421 422 423 424 425 426 427 428 429 430 431 432 433 434 435 436 437 438 439 440 441 442 443 444 445 446 447 448 449 450 451 452 453 454 regulators), as well as any cases that might lead to a labeling change decision.

Follow-up information should be obtained, via a telephone call and/or site visit and/or via a written request. Efforts should be tailored toward optimising the chances to obtain the new information. Written confirmation of details given verbally should be obtained whenever possible. In exceptional circumstances, a regulatory authority might be able to assist an MAH to obtain follow-up data if requests for information have been refused by the reporter. The company should provide specific questions it would like to have answered.

In order to facilitate the capture of clinically relevant and complete information, use of a targeted questionnaire is encouraged, preferably at the time of the initial report. Ideally, healthcare professionals with thorough pharmacovigilance training and therapeutic expertise should be involved in the collection and the direct follow up of reported cases (particularly those of medical significance). For serious ADRs, it is important to continue follow-up and report new information until the outcome has been established

or the condition is stabilized. How long to follow-up such cases will require judgment. MAHs should collaborate on follow-up if more than one MAH’s drug is suspected as a causal agent in a case.

It is important that, at the time of the original report, sufficient details about the patient and reporter be collected and retained to enable future investigations, within the constraints imposed by local data privacy legislation.

4.4.1. Follow-up Related to Pregnancy Exposure

MAHs are expected to follow up all reports, from healthcare professionals or consumers, of pregnancies where the embryo/foetus could have been exposed to one of its medicinal products. When an active substance, or one of its metabolites, has a long half-life, this should be taken into account when considering whether a foetus could have been exposed (i.e. medicinal products taken before the gestational period need to be considered). If a pregnancy results in an abnormal outcome that the reporter considers might be due to the drug, this should be treated as an expedited report if the criteria for expedited reporting are met.

4.5. How to Report

The CIOMS I (Council of International Organisations for Medical Sciences) form has been a widely accepted standard for expedited adverse event reporting. However, no matter what the form or format used, it is important that certain basic information/data elements, when available, be included with any expedited report, whether in a tabular or narrative presentation. It is recommended that the Medical Dictionary for Regulatory Activities (MedDRA) be used for coding medical information. The standards for electronic submission of Individual Case Safety Reports (ICSR), according to ICH

E2B/M2, should be implemented.

The listing in the Attachment addresses those data elements regarded as desirable; if all are not available at the time of expedited reporting, efforts should be made to obtain them.

455 456 457 458 459 460 461 462 463 464 465 466 467 468 469 470 471 472 473 474 475 476 477 478 479 480 481 482 483 484 485 486 487 488 489 490 491 492 493 494 495 496 497 498 499 500 Reference Sources

1. Current Challenges in Pharmacovigilance: Pragmatic Approaches (CIOMS V), 2001

2. Rules Governing Medicinal Products in the European Union, Volume 9, PHARMACOVIGILANCE: Medicinal Products for Human Use

3. Guidance for Industry: Postmarketing Safety Reporting for Human Drug and Biological Products Including Vaccines, Food and Drug Administration, March 2001 (draft)

4. Safety Reporting Requirements for Human Drug and Biological Products, Proposed Rule, Food and Drug Administration, March 2003

5. Notifications #421 on the Enforcement of Revised Pharmaceutical Affairs Law, the Director General, Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, March, 1997

Attachment

RECOMMENDED KEY DATA ELEMENTS FOR INCLUSION

IN EXPEDITED REPORTS

OF SERIOUS ADVERSE DRUG REACTIONS

The following list of items has its foundation in several established precedents, including those of CIOMS Ia; the WHO Collaborating Centre for International Drug Monitoring, Uppsala; and various regulatory authority forms and guidelines. Some items might D not be relevant depending on the circumstances. Attempts should be made to obtain follow-up information on as many other listed items as are pertinent to the case.

1. Patient Details

?Initials

?Other relevant identifier (patient number, for example)

?Gender

?Age, age category (e.g., adolescent, adult, elderly) or date of birth ?Concomitant conditions

?Medical history

?Relevant family history

2. Suspected Medicinal Product(s)

?Brand name as reported

?International Non-Proprietary Name (INN)

?Batch number

?Indication(s) for which suspect medicinal product was prescribed or tested

?Dosage form and strength

?Daily dose (specify units - e.g., mg, ml, mg/kg) and regimen

?Route of administration

?Starting date and time

?Stopping date and time, or duration of treatment

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544 3. Other Treatment(s) The same information as in item 2 should be provided for the following: ? Concomitant medicinal products ? (including non-prescription, over-the-counter medicinal products, herbal remedies, dietary supplements, complementary and alternative therapies, etc.) . ? Relevant medical devices 4. Details (all availabl l e) of Adverse Drug Reaction(s) (s) ? Full description of reaction(s), including body site and severity ? The criterion (or criteria) for regarding the report as serious ? Description of the reported signs and symptoms ? Specific diagnosis for the reaction ? Onset date (and time) of reaction ? Stop date (and time) or duration of reaction ? Dechallenge and rechallenge information ? Relevant diagnostic test results and laboratory data ? Setting (e.g., hospital, out-patient clinic, home, nursing home) ? Outcome (recovery and any sequelae) ? For a fatal outcome, stated cause of death ? Any autopsy or other post-mortem findings (including a coroner's report) 5. Details on Reporter of an ADR ? Name ? Mailing address ? Electronic mail address ? Telephone and/or facsimile number ? Reporter type (consumer, healthcare professional, etc.) ? Profession (specialty) ? Source of report (spontaneous, epidemiological study, patient survey, literature , etc.) ? Date the event report was first received by manufacturer/company ? Country in which the event occurred ? Type (initial or follow-up) and sequence (first, second, etc.) of case information reported to authorities ? Name and address of MAH ? Name, address, electronic mail address, telephone number, and facsimile number of contact person of MAH ? Identifying regulatory code or number for marketing authorisation dossier ? Company/manufacturer's identification number for the case (this number must be the same for the initial and follow-up reports on the same case).

安规知识大全

安规知识大全 安规知识大全 第一章安规基本知识 一. 安规的定义及目的. 1. 定义: 各国依设备使用之范围而制定之安全规范. 2. 申请安规的目的: 为保护使用者生命、财产之安全.如不受电击, 火灾等之危险. 二. 一般通用安规标准. 1. 基本上是依IEC 国际标准,各国依据国家不同之需求而制订其标准. 2. 如IEC60950 ( Information Technology Equipment 资讯类产品) 3. USA –UL60950 4. 欧盟–EN60950 5. 中国–GB 4943 6. 澳洲–AS3260 7. 日本–J60950 8. 韩国–K60950 9. 没有特别制定标准号码, 仍为IEC60950 – 10. 新加坡,阿根廷. 11. 医疗设备–IEC60601 12. 视讯产品–IEC60065 13. 家电类产品–IEC60335 IEC 安规standard 一般订名称IEC60XXX EMC standard一般订名称IEC61000- 三. 一般通用电压. 1. 北美–US, Canada 120V, 60Hz 2. 中南美–220V 较多,有的国家也有120V 3. 欧盟–230V, 50Hz (因为英国原本是240V,其他西欧国家为220V,因此折中220V ) 4. 东欧–一般为220V, 50Hz 5. 日本–100V, 50 HZ澳洲,纽西兰–240V, 50 Hz 6. 其他国家以220V居多.如:中国,韩国,东南亚国家. 四. 电源供应形式. 1. Adaptor –有塑胶外壳 a. Class I 有接地pin b. Class II没有接地pin (双重绝缘)使用Inlet 直接插墙式Open Frame –没外壳和有铁壳 五. CB Report 1. 何谓CB report . 2. CB - Certify Body 认证单位.

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我也了解到自己在文科方面很难得到提高。对此,我恳请杨老师能让我转到理科高二(16) 班,我真切希望自己能转理科高二(16)班,我总结了我转班的原因,有以下几点: 一、 我觉得自己对文科的兴趣没有了之前的那种热情,而且我觉得自己在理科方面还有待提高,我 对它也很感兴趣。人们都说兴趣是学习最好的老师,有了兴趣就是成功的一半。而现在我对文 科已经没有了那种热情,又怎么会对学习文科尽心尽力、认真努力的去做呢?所以我真心的想 转到理科。 二、 我的文科成绩不是很好,而且从小我就贪玩把英语落下了很多。然而英语在文科当中可以占很 大的优势,我的英语很差,读文科没有优势,所以我希望自己能转到理科。 三、 学习文科需要很好的记忆力,但我这个人很赖,不喜欢背诵,而文科又需要背诵和 忆。 四、 根据社会的需求和我个人的发展空间,我想理科更适合我。 亡羊 补牢,为时不晚,希望杨老师能给我一次机会。 此致 敬礼 申请 人: 011年7月31日 篇四:申请书 尊敬的政府领导: 我叫 xxx,19xx年xx月xx日生,系xxx居民,配偶19xx年生,也是xxx人,我们都无固定 职业,现有家庭成员x人,家庭月收入xxx元。我们也曾经多次想买房子,但就我们这点收 入想买完全属于我们自己的房子那简直是奢望。所以本人和家人至今也一直居无定所,但为了 生活,又不得不在城区内四处奔波打工,并租房居住。由于本人家庭生活的实际困难和无住房 的实际情况,现想申请政府廉租住房一套,望领导给予批准为盼! 谢谢! 请人:

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華儀電子股份有限公司EXTECH Electronics Co.,Ltd Seminar 2007 市場部行銷組 彭刚杰 Content 主要內容 华仪电子简介 安规测试的必要性和重要性 安规测试的基本原理及要求 安规测试仪的新型技术 安规测试的实际应用 华仪新产品的介绍 疑问讨论及解答 Extech Electronics Co ., Ltd ?2007

Company History 公司发展 成立于1978年,为台湾第一家变频电源专业制造厂,主要客户为电子产品之生产厂商 随后,扩增稳压器/变流器及充电机的设计研发与生产,成为知名的生产设备专业制造厂 90年代初期,研发安规测试器(MODEL:CRW-100)为台湾第一台4合1的安规测试仪器,正式成为T&M仪器制造厂 1998年,全系列产品通过ISO9002品质认证,及安规系列产品获得TUV/GS安全认证 1999年,推出安规自动化测试软件及系统 2001年,荣获ISO9001:2000认证 Extech Electronics Co ., Ltd ?2007 Future 愿景 成爲世界知名的儀器品牌 To be a well-known equipment manufactory on the world. Extech Electronics Co ., Ltd ?2007

Mission Statement 使命 以專業科技,提供完善品質與服務,開創永續經營 To serve our customers with quality products and service using professional technology. To create profits, so that we can perpetuate our business. Extech Electronics Co ., Ltd ?2007 Sales in the world 全球销售据点 臺北縂公司Headquarter in Taipei 中國廣州Guangzhou China 中國蘇州Suzhou China 馬拉西亞Malaysia 澳大利亞Australia 日本Japan 韓國Korea 印度India 新加坡Singapore …… Extech Electronics Co ., Ltd ?2007

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安规基本知识

安规的基本知识 一、安规简介:一般每个国家均有自己国家的安全规范,而且不同的国家或 地区对安规所对应的要求也不相同。 例如: 中国——GB;国标即将于2002年由3C标志所取代。长城认证及CCIB 与中国检验检疫局统称3C标志,凡内销产品务必申请。 日本——JIS;日本安规即将于2002年4月1日由PSE标志所取代。 美国——UL;加拿大——CSA;德国——VDE;英国——BSI;欧洲——GS; 澳地利——VE;智利——SICAL;墨西哥——NOM 由于各国的使用电压基本集中于AC 220V~240V 50HZ和AC 110V~120V 50HZ;60HZ。故通常我们将安规分为两种(GS UL)。GS一般是欧洲方面的安规(AC 220V~240V 50HZ)的简称。而UL一般指美国,加拿大等(AC 110V~120V 60HZ)的简称。中国的国标(GB)是与IEC 335-1(1991)第3版等效的,IEC是国际电气技术委员会简称。 二、安规的基本知识。 安规所涉及的知识和范围十分广泛,而且纷繁复杂,如果要详细的讲述,几乎不可能几乎要通合几十种不同方面安规的测试,下面简单的讲一下测试名称: 1.产品的干烧寿命测试; 2.电源线的拉力; 3.耐压测试; 4.跌落强度测试; 5.电源线曲折性能测试; 6.溢水测试; 7.泄漏电流测试; 8.斜度测试; 9.开关旁路测试; 10.温升测试等等。 三、安规知识的作用

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文科生申请日本留学的条件.doc

文科生申请日本留学的条件 现在,的女生比较多,一般女孩子选择文科会多一些,那文科生寻求自身更好地发展选择去日本留学申请条件是什么满足什么条件才可以申请?有什么专业可以选择?今天就来说说文科生申请日本留学的条件! 文科生去日本留学 文科生留学日本费用 日本留学性价比很高,它有着高水平教学质量,和较为亲民学费。 日本国公立大学学费 本科:53.5万日元/年约3万人民币 研究生:17万日元/半年约1万人民币 修士:53.5万日元/年约3万人民币 日本私立大学学费较国公立大学要高一些,文科相关专业学费大致如下: 本科:约70-90万日元约4-6万人民币 修士:约100-140万日元约6-8.4万人民币 另外日本设有各类奖学金,可以为同学们减轻一部分经济压力。 日本文科专业录取分析 出身校 日本文科对于学生背景学校没有明确限制。但是985、211背景出身学生申请前五名大学成功率则大很多,尤其是京都大学非常喜欢招收国内985、211院校学生。 语言要求 申请日本文科学校语言成绩非常重要,除获得日语成绩学生占绝大部分优势外,如果能掌握非常流利英语能力也很具有竞争优势。

专业背景 本专业申请和跨专业申请基本持平,但还是本专业申请学生占据优势。文科跨专业一般多是指日语专业同学选择其他专业继续攻读。 最为常见是攻读教育学和社会学,因为比起商科专业对专业出身要求低一些;也有一部分英语好日语专业学生转去研究国际关系或国际协力;也有一部分经贸日语专业学生成功申请到商科专业。 当然还有一部分日语专业学生选择继续本专业进学,多会选择研究日本语教育、日本文化或文学。 文科生留学日本读研基本条件 研究生(修士预科) 学历: 16年教育经历,大学本科生,拥有学士学位或专升本、自学考试学位取得者(可申请修士研究生);只有个别学校接受专科生,基本需要进行申请资格审查。 语言能力: 申请日本研究生一般来说文科专业日语水平需N1,N2也可,当然日语水平越高对申请会约有利。 修士 学历: 受过16年正规学校教育、具有本科毕业证和学士学位证者或受过15年教育专科生,但是需要资格审查,可以选择学校较少。 语言能力: 日语,根据大学、学科具体要求不同。有要求提供日语能力证明,有需要通过面试来判断是否达到可以满足研究需求语言水准。

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100V—240V; 2.8A 100V—240V; 2.8—1.1A 200V—240V; 1.4A 对多个额定电压: 120/ 220V ; 2.4/1.2A 2)电源的性质符号: 直流——交流~(GB8898-2001) ii.制造厂商名称或商标识别标记 iii.型号 iv.符号“回”,仅对Ⅱ类设备适用。

工程师设计时常见错误: Ⅱ类设备大标贴没有“回”字符 没有LOGO或LOGO与认证证书不是同一公司 交流输入性质用“AC”表示,不用“~”表示 具有额定电压范围或多个额定电压的设备,电流标示本应是“100V—240V; 2.8—1.1A”或“120/ 220V ; 2.4/1.2A”,错写成“100V—240V; 1.1—2.8A” 或“120/ 220V ; 1.2/2.4A” 8、保护接地和等电位连接端子标示 预定要与保护接地导线相连的接线端子 应标示符号,该符号不能用于其它接地端子。 对保护连接导线的端子不要求标示,

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1的比例,甚至有一些学校的研究生比本科生还多。 研究生主要是为了培养水平更高的人才。所以很多国家对于研究生的招收都会考察学生专业的知识掌握得如何。但是在美国这里的研究生招收,却不会对学生的专业基础有太多的考察。他们在招收硕士的时候都是用通用考试,主要是为了看学生有怎样的培养潜力。比如像是GRE这个考试是为了考查学生对于英语、数学等等方面的应用,就算是商学院必须要考的GMAT都不会有专业基础的内容。 要想进入研究生院确实不难,不过这不代表大家在申请到了之后就能不用想别的了。美国对于研究生们的要求还是很严的,学业上有非常重的负担。老师并不因为学生对于课程都是零起点就放慢教学进度,在这里,一个星期的课程内容就等同于本科一两个月的内容。此外老师还会让学生在课外做大量的阅读以及经常让学生写论文。 美国这边对于学位的规定是,只允许学生在得到学士学位后再去读研究生的学位。在学位体制上,美国采用的是五级制,而硕士的学位就有两种:一种要写论文,一种不需要写,不过学分就要求得比较高了。 而且在硕士学位上还有两种分类,就是文理科以及专业的硕士。文理科一般学分都需要要到24-30这个阶段,不过大多都是本专业的课程。专业硕士就有很明确的=定义了,会在学生的学位头衔前标明这个学生学的专业,而且这一类的课程会设置得非常紧凑,当然了,这些课程的声誉也较高。 美国在奖学金上也有很多种类,光是一个高校奖学金都能有服务性、非服务性以及贷款等等几种类别。不过美国大部分的高校都是会设置前两种奖学金给学生。虽然说此类资助不一定能包含学生一年中的费用,不过基本都能包含了2/3以上的费用。

参加高考申请书范文(精选多篇)

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