Tiếng Anh và mức độ quan trọng đối với cuộc sống của học sinh, sinh viên Việt Nam.Khi nhắc tới tiếng Anh, người ta nghĩ ngay đó là ngôn ngữ toàn cầu: là ngôn ngữ chính thức của hơn 53 quốc gia và vùng lãnh thổ, là ngôn ngữ chính thức của EU và là ngôn ngữ thứ 3 được nhiều người sử dụng nhất chỉ sau tiếng Trung Quốc và Tây Ban Nha (các bạn cần chú ý là Trung quốc có số dân hơn 1 tỷ người). Các sự kiện quốc tế , các tổ chức toàn cầu,… cũng mặc định coi tiếng Anh là ngôn ngữ giao tiếp.
UNIVERSITY OF HEALTH SCIENCES SCHOOL OF BASIC SCIENCES DEPARTMENT OF FOREIGN LANGUAGES MASTER PROGRAM ENGLISH PHARMACEUTICAL MAJOR COMPILED BY TIENNGUYEN OCTOBER 2016 FINAL TEST FORMAT – MASTER PROGRAM – 2016 TIME: 90 MINUTES FORMAT LISTENING SECTION (20 PTS) TRACK 1: MCQ TRACK 2: TRUE/FALSE/ NOT GIVEN WRITTEN SECTION (70 PTS) SOURCES PHARMACEUTICAL INDUSTRY COURSEBOOK ENGLISH IN PHARMACY SECTION I: GRAMMAR – VOBULARY – STRUCTURE (30 pts) PART A: MULTIPLE CHOICE PART B: SYNONYMS PART C: ERROR IDENTIFICATION SECTION II: READING COMPRHENSION (40 pts) Passage 1: MCQ Passage 2: GAP FILLING Passage 3: TRUE/FALSE/NOT GIVEN Passage 4: MCQ SECTION III: SPEAKING TEST (10 pts) 14 SPEAKING TOPICS SPEAKING TOPICS - MASTER PROGRAM – 2016 WHAT IS PALLIATIVE CARE? 2 WHAT ARE FUNCTIONAL FOODS? WHAT IS PHARMACEUTIAL MAJOR? HOW IS COSMETIC INDUSTRY GROWING? HOW IMPORTANT ARE BIOLOGICAL DRUGS? INTRODUCE SOME ACHIEVEMENTS IN PHARMACY! WHAT ARE THE PRINCIPLES OF PHARMACOLOGY? WHICH ASPECTS ARE INCLUDED IN PUBLIC HEALTH? HOW WILL THE FUTURE OF PHARMACEUTICAL INDUSTRY BE? 10 WHAT ARE THE CURRENT TREATMENTS TOWARDS CANCERS? 11 HOW IMPORTANT ARE RANDOMIZED CONTROL TRIALS TO HEALTH CARE? 12 WHAT IS KNOWN ABOUT EVIDENCE-BASED MEDICINE IN THE CLINICAL SETTING? 13 WHICH CHARACTERISTICS ARE REQUIRED TOWARDS A PHARMACEUTICAL REPRESENTATIVE? 14 WHICH ROLE IS HERBAL MEDICINE PLAYING IN PHARMACEUTICAL INDUSTRY? DAY - CLINICAL TRIALS MCQ Any treatment can be moved into clinical trials without safety investigation A True B False The 4th trial must be done after one drug is already approved on the market A True B False People volunteer to participate in clinical trials……………… different reasons A Despite B Because C Because of D Thanks to Which of the following is not considered as a treatment? A Gene therapy B Medical device C Assembly line D Biologic products Which process happens in the final stage? A Marketing B Clinical trial C Initial discovery D Product development Which factor below is not included in one protocol? A Which procedures B Who will perform this procedure C The reason to conduct this procedure D d Which constitute to hold this procedure What is the difference between phase and trials? A Safety concern B Efficacy concern C Side effect detection D Number of participant Which information is incorrect about phase trial? A It continues tests the efficacy of the drug B The result depends on the length of the trial C It is conducted in small number of participants D It compares the pre-existing and existing treatment Which process must be involved in both phase and 3? A Randomization B Single-blinding test C Double-blinded test D Standard procedure of control 10 Which information is INCORRECT about blinding feature? A The identification will be allowed at the end of the trial B Single-blinding means participants know which medication they are receiving C Thanks to blinding, bias does not affect the trial or the interpretation of its results D A double-blinded trial means that neither the team nor the participants know about each other EXERCISE - PAGE Advancing medical knowledge is the most premier reason to participate in a trial Around three quarters participants in the 2000 Paris Poll did believe in the best quality offering from the treatment tested Some participants also have similar specific disease related to the tested treatment David Banks is a clinical pharmacist from FDA Financial issue isn’t recognized as the most crucial reason to participate in a trial From the text, participants attracted by compensation will face possible risks There has been no argument over the total reliability of clinical trials Any side effects can be temporary or permanent All side effects take place during treatment 10 main factors deciding the risk of the treatment on participants from any clinical trial are the treatment and the participants’ health FDA – EXERCISE – PAGE 35 FDA plays an important role in assuring safe and effective drugs, food and cosmetics available Any scientific research must be rigorously and carefully conducted The length to complete a clinical trial as well as the costs to introduce the final treatment is mentioned in the text The FDA-approved drug label contains the information shortened from the huge results from the clinical trial on that treatment Pre-clinical testing is performed on animals while human being is the target of clinical studies Besides FDA, IRB is also involved in examining the phases in a clinical trial Without controlled clinical studies as well as the final decision from FDA, no treatment can be legally available on market Price should be also included in the data submitted to FDA for official approval Only prescription drugs are overseen closely, especially in promotion and advertising 10 Any information related to safety and side effect of the accepted drugs must be reported continuously to FDA DAY PHARMACEUTICAL COMPANIES – PAGE 10 Which event happened in the 1920s and 1930s? A Insulin and penicillin were discovered B Insulin and penicillin were mass manufactured C Most pharmaceutical companies were founded D More & more new drugs were developed Which leads to marketing change in the 1990s? A Internet development B New FDA regulation C A new business atmosphere D New consumerism What are the benefits of the pharmaceutical industry in the 1980s? A The introduction of new safety & environmental regulations B New DNA technologies for analysis & computation C A and B are correct D A and B are incorrect What is the difference of the pharmaceutical industry before & after the 1950s? A The distinguishing between prescription & nonprescription drugs B Systematic scientific approach development C Labeling requirement D More serious legislation enaction Which statement is INCORRECT? A Valium may lead to habituation B Thalidomine may cause serious birth defects C The new antidepressant, SSRI, was rejected by FDA D The first oral contraceptive was a mass production When did pharmaceutical industry begin to expand its business scale? A In 1970 B Before 1970 C After 1970 D Mid-1980s What information is INCORRECT about Declaration of Helsinki? A A proven clinical trial is a must before marketing B Introducing the standards for clinical research C Requiring participants’ agreement before joining a clinical trial D Allowing financial link between pharmaceutical companies & prescribing physicians Which of the following is the most prominent feature in the 1970s? A Contraceptive pills B Drugs for heart failure C Cancer drugs D Drugs for AIDS TRUE/FALSE/NO INFORMATION Pharmaceutical companies have been established since the late 19th century Insulin and penicillin have always been the most important drugs on market Labeling requirement could be done without any legislation Human biology knowledge helps the pharmaceutical industry get underway in earnest The 1st oral contraceptive pills were only mass-produced in the 1960s Dependency and habituation caused Valium be banned from the market The issue of financial links between physicians and pharmaceutical companies faced attempts to be controlled according to the new US FDA regulation Before the Helsinki Declaration, the participants did not have to state their agreement in involving in any clinical trial Since the 1960s, efficacy and safety in clinical trials before marketing drugs have become effective 10 It was the mutual formation among small pharmaceutical companies created the concentrated character of the pharmaceutical industry 11 Heart disease and HIV drugs became the focus in the 1980s 12 R&D mission have received more attention since the 1990s according to the institutionalized business atmosphere 13 The Internet brings more comfort to the pharmaceutical purchasing 14 Public advertising for pharmaceutical products became more popular in the 1990s 15 Advertising in the 1990s was liberalized without mentioning the risks 16 Laboratory design and natural-product surveys create the basic differences between drug developments in the past and at present PLACEBO – PAGE Which information is INCORRECT? A Placebos look exactly the same as drugs B Placebos include active ingredients & excipients C Starch or sugar is classified as inactive substances D Placebos are used in clinical studies Find INCORRECT information about “placebo effect”: A Any placebo effect can be desirable or undesirable B factors such as anticipation result & spontaneous change are typical for placebo effect C Without treatment, spontaneous improvement can hardly be achieved D Any spontaneous change is positive or negative Which statement below is NOT GIVEN in the text? A Patients’ psychological opinions decide the success of placebo use B Dose increase takes place in developing compulsiveness in drug using C Susceptibility to the placebos is higher than that to medications D In case of being deprived of the placebo, withdrawal symptoms occur OFF-LABEL – PAGE 12 Which information below is INCORRECT? A Only prescription drugs are concerned B Drugs are approved by FDA from numerous clinical trials C Drugs are used off-label in USA D FDA allows off-label use in wider population Which drug below must be prescribed or controlled strictly? A Opiates B Amphetamines C OTC drugs D POM drugs Which information is NOT FOUND on the drug’s label? A Dosage B Administration C Indication D Pharmacy location A B C D A B C D Find the INCORRECT information! Most drugs are prescribed off-label rather than their original Cancer treatment involves the off-label use of one or more drugs Side effects are revealed from the old class of antidepressants Tricylic antidepressants can be considered as painkillers Which function below is NOT PERFORMED by FDA? Requires numerous clinical studies to prove a drug’s safety & effectiveness FDA agrees on specific language on the drug’s label FDA approves only for prescription drugs on market FDA permits detailed indications for all drugs available on market COUNTERFEIT - PAGE 15 Counterfeit medicine issue has become an irritating one in EU Counterfeit medicines are supplied on the Internet, from pharmacies, or through supply chain Toxic substances are discovered in counterfeit medicines Little or no active ingredient is contained in counterfeit medicines The more serious illnesses are treated by counterfeit medicines, the more dangerous effects happen to those patients Only experts can recognize the counterfeit and the original medicines EU rules accept products to be re-boxed, re-labeled or over-stickered, which makes it harder to distinguish real medicines from fakes Other ways to assist authorities in distinguishing fake from real medicines from individual companies, besides security features, have proved their effectiveness against counterfeit medications The original package has been considered as a prerequisite for an effective anti-counterfeiting strategy 10 EU health authorities are cooperating with Asian ones for more effective campaigns against counterfeiting medications ORPHAN MEDICINES – PAGE 16 Orphan drugs, named as rare drugs for rare diseases, are produced under abnormally special circumstances It takes huge capital and cost to produce any orphan drug More and more orphan drugs have been researched and manufactured and available on market ODA is a sub-division of FDA majoring regulations related to orphan drugs DAY BAYCOL – PAGE 30 What happened in 2001? A Some patients taking Baycol died from a serious muscle disorder B Baycol was withdrawn from the market, except Japanese one C This was a hard year for Bayer company executives D A or B or C is correct What is the ULTIMATE purpose of a simple blood test (CPK level)? A Identifying the degree of skeletal muscle destruction B Deciding whether to stop the use of statin C Being sure whether the patient is having muscle pains & aches D Assisting physicians in continuing to prescribe statin drugs to patients or not How serious is rhabdomyolysis? A Skeletal muscle cells die B A massive amount of muscle protein into the bloodstream C Muscle protein trapped in the kidneys D Kidney failure & other organ system disorders Which information is INCORRECT? A The combination between statin and gemfibrozil is the best B Korey Stringer died of heart stroke C Statin should be disconnected in patients with muscle pain D For Baycol tragedy in 2001, patients died due to doctors’ highest prescribed dose From Baycol case, it can be inferred that other statins alone can cause actual rhabdomyolysis A Correct B Incorrect Which is the safe & recommended dose for Baycol? A O.4mg B 0.8mg Baycol is purchased normally in Japanese market A Correct B Incorrect The problem with Baycol should not create any additional concern A Baycol itself is a concern B Other statin drugs but Baycol are safe enough C Baycol must be expelled from the market due to its harms D As long as Baycol is prescribed conservatively without the use of gemfibrozil, Baycol is another recommended choice Which information is INCORRECT? A It is clearly stated that statin combined with Gemfibrozil causes muscle problems B Patients or doctors have no idea about this problem of this combination C Gemfilbrozil is a lipid-lowering agent D Patients taking Baycol died due to Gemfibrozil and highest dose usage 10 Which information related to rhabdomyolysis is INCORRECT? A Rare if considered as a side effect B Similar to low-grade muscle disorder C Happens after massive muscle trauma D Is caused by Baycol LIPITOR – PAGE 18 10 originally made in the shape of a disk of whatever color their components determined, but are now made in many shapes and colors to help distinguish different medicines Tablets are often stamped with symbols, letters, and numbers, which enable them to be identified Sizes of tablets to be swallowed range from a few millimeters to about a centimeter Some tablets are in the shape of capsules, and are called "caplets" Medicinal tablets and capsules are often called pills However, pills are ancient solid dose forms prepared by rolling a soft while tablets are made by compression Other products are manufactured in the form of tablets which are designed to dissolve or disintegrate; e.g cleaning and deodorizing products QUESTIONS What does a tablet have? A active substances C A and B are correct B excipients D A and B are not correct What are disintegrants used for? A ensure efficient tabletting B promote tablet break-up in the digestive tract C enhance taste D make the tablets visually attractive What are flavours used for? A ensure efficient tabletting B promote tablet break-up in the digestive tract C enhance taste D make the tablets visually attractive What make the tablets visually attractive? A glidants C pigments B sweeteners D binders A tablet has a polymer coating because A to make the tablet smoother and easier to swallow B to control the release rate of the active ingredient C to make it more resistant to the environment D All are correct What is the most popular dosage form in use today? A Tablet C Powders B Capsule D Injectable solutions How we take tablets? A Orally C Buccally B Sublingually D Rectally What is another form of medications that can be taken orally ? A Syrups C Suspensions B Elixirs D All are correct Which enables tablets to be identified ? A shape C symbol B color D all are correct 10 What is another name of tablets and capsules ? A Caplets C Bills B Pills D Capsules 32 HOSPITAL PHARMACY The professions, concerned with health care, work together as a team No where is this more evident than in the hospital services A person taking up such career can be assured of a challenging but interesting job, one that changes rapidly in response to development in the health care field The pharmacist must be able to integrate well with co-workers, for example, doctors, nurses or radiologists The pharmacist is primarily responsible for supplying medicines as efficiently and economically as possible, for their secure and proper storage and for their distribution throughout the hospitals The quality, safety and use of medicines must be closely monitored by the pharmacist Also, the hospital pharmacy is the center of drug information The pharmacist is expected to lecture nurses and medical students on the actions of drugs, odes rates, side effects and related problems They act on the drug therapeutic committees where overall policy is determined in relation to drug usage, new products, clinical trials, infection control and the hospital formulary 20 “Nowhere is this more evident than in hospital services” a This evidence is very persuasive b Hospital service is the best c Pharmacists, in any places, work together in a team d Pharmacists, especially in hospitals, work together as a team 21 According to this passage, which is not a duty of hospital pharmacist? a Develop health care field c Monitor drug distribution b Integrate with co-workers d Assist nurses and medical students 23 Which of these is not considered as a co-worker of hospital pharmacists? a Security c Nurses b Radiologists d Doctors 27 How are medicines supplied throughout the hospitals? a Efficiently and economically c Efficiently and wastefully b Efficiently and carefully d Efficiently and carelessly 28 Which factor of medicines is not necessary for being monitored? a Use c Quality b Safety d Package 30 Which of the following is not listed in a pharmacist’s therapeutic committee role? a Dose rate b Drug usage c Infection control d Clinical trial THIS IS THE END OF THE WRITTEN EXERCISE 33 LISTENING PRACTICE PHARMACEUTICAL INDUSTRY TRACK 2: CHOOSE THE MOST APPROPRIATE ANSWERS Which information is INCORRECT? A The meeting is using the video conferencing technique B No direct eye contact is the weak-point of this technique C The chairman is asking participants to introduce themselves briefly D Time saving and confusion avoidance are the strongpoints of this technique Which statement is INCORRECT? A This new product is a pain killer B The meeting is aimed at getting a full list to C A new analgesic is being introduced into market D The brand-name of this new product has been decided yet Who is the chairman of this meeting? A Harvey B Anna C Walter D Charley What is Anna’s professional background? A Pharmaceutical industry B Clinical pharmacy C Pharmacognosy D Pharmacology What is her current job title? A Clinical trial executive B Clinical trial associate C Clinical trial administrative D Clinical trial manager Which information below is INCORRECT about Anna? A Clinical methodology was her research focus B Her license to practice pharmacy was obtained in America C After master graduation, she began to work here years ago D Two other clinical research associates are assisting her with test centers Which information below is NOT included in Walter’s brief introduction? A Full name B Marital status C Academic qualification D Specific daily job description What is Walter’s academic PhD major? A Pharmaceutical B Pharmaceutical Industry C Pharmaceutical Management D Pharmaceutical Chemistry Which information below is INCORRECT? A He used to work for R&D Department B He is currently the formulation team leader C Two other dosage forms are under the responsibility of another team D His team is designing the soft capsule for this new pharmaceutical product 10 Which detail is NOT included in Charley Wu’s introduction? A Hometown B Employment history C Current job duties D Family condition 11 Which duty below has Charley NOT performed yet? A Line worker B Packaging technician C Plant manager D Project manger 12 Which medicinal form below is NOT produced in the facility in Shanghai? A Liquid B Solid C Capsule D Paste 34 TRACK 3: ANSWER THE FOLLOWING QUESTIONS IN COMPLETE SENTENCES Which two issues will be reviewed to make sure each person’s role for the st stage? -> Through which channel will Iris Berger introduce the job advertisements? -> What is the purpose of this job advertisement? -> Where are the test centers for the clinical trials? -> What is Walter’s duty by the end of next month? -> Which information related to the project is included in the estimation by Department Head? -> Which two duties are assigned to Charley’s team? -> When is the deadline for Rasheed’s review of legal or regulatory issues? TRACK 4: DECIDE WHETHER THESE STATEMENTS ARE TRUE OR FALSE OR NOT GIVEN This piece of listening is aimed for an employment advertisement This pharmaceutical company is a domestic one The study centers are located all over the world 35 Controlling the clinical drug trials includes investigator recruitment and documentation collection The job title is clinical research associate Scientifically and technically precise writing skill is a must for the candidates Visiting study centers occupies approximately half the travel time The higher qualifications the candidates achieve, the more likely he or she will be considered for the vacancy Any newly graduates can apply for this job position 10 Mastering FDA as well as EMEA regulations is another requirement 11 Individual working ability is more evaluated than teamwork capacity 12 Clinical trial management does demand communication skills TRACK 5: FILL IN THE CORRECT MISSING PREPOSITIONS Thanks all you coming To start To know the new substance To work the new project To develop To be interested Information available To be the toxicity the substance a position To talk 36 10 To make the new dosage form the current technology TRACK 6: DECIDE WHETHER THESE FOLLOWING STATEMENTS ARE TRUE OR FALSE OR NOT GIVEN To produce MensamintTM form is a possibility for this pharmaceutical company Further tests are being taken place to find out more about side effects What they are in need, currently, is time Up to now, the patch form has been the most problematic issue to the staff in charge Other forms, except patch, have been proved to work well It takes a long time, from months to some years, to develop the patch form It also takes a lot of money to develop a patch form The gel tablet or a pill is another possible option besides patch They are more confident in developing gel or pill form due to the well-equipped technologies 10 In the next weeks, the technology to develop drops or syrups can be available to be applied 11 Janet is working in Production Department 12 The final report on all potentially available forms must be presented towards John at the following meeting TRACK 7: CHOOSE THE MOST APPROPRIATE ANSWER FOR EACH QUESTION In which country is the survey completed? A Poland B Netherland C Switzerland D Scotland Which is the general scientific goal of this survey? A Hospital inpatient medication dosage forms B Hospital outpatient medication dosage forms C Hospital ICU patient medication dosage forms D Hospital general patient medication dosage forms 37 Which features related to the questionnaire is John interested in? A The number of interviewed patients B The number of male interviewees C The number of female interviewees D All are correct Which general information below is INCORRECT? A The survey was conducted in different hospitals B Nearly 2,000 patients participated in this survey C Their age ranges from 37 to 63 D The percentage of male patients is lower than that of female ones Which oral dosage is NOT currently used? A Caplets B Tablets C Pills D Capsules Which finding below related to the favorable dosage forms is INCORRECT? A It is hard to swallow solid oral dosage forms B Drops or syrup are mostly preferred C Gel tablets or capsules outweigh drops or syrup D Aerosols, creams, ointments or patches are the least favorite forms What does John mean when replying to Helen: “That’s just what I was hoping to hear!”? A Helen’s statistics turns out to be correct B Helen’s statistics is satisfactory C Helen’s statistics becomes flawless D Helen’s statistics meets John’s expectation How is the conclusion, from Helen’s point of view, related to the patients’ chronic health problem? A It has changed B It provides a chance C It may sound strange D It looks like a chain Why are those patients admitted into hospital? A To have their chronic health problems treated B To have their general health conditions checked-up C To have some less major health problems treated D To participate in this survey CÂU 10 How can John receive information concerning to his demand on patients’ other major health problems? A Yahoo messenger B Viber application C Hotline use D Email means TRACK 8: DECIDE WHETHER THESE STATEMENTS ARE TRUE OR FALSE OR NOT GIVEN An internal audit will take place in weeks There are participants in this meeting GLP (Good Laboratory Practice) requires the laboratory safety procedures There should be a special training before for this audit 38 All laboratory staff is suggested to have a review of laboratory safety procedures with laboratory technicians All laboratory staff is expected to be able to answer auditors’ all possible questions The idea to cancel the trip to Vienna is not accepted At least lab technicians should be present during the audit A memo with all possible auditors’ questions from the company’s internal audit checklist has been distributed to all lab staff 10 If any non-compliance were detected, the auditors would take notes in the checklist and inform to the company for corrective or preventive actions 11 They can’t know how to solve the problem related to a lab staff’s absence on holiday abroad 12 All the procedures given in the profile need to be reviewed carefully 13 Lab staff has just moved into a new office so they are having problem with materials or documents 14 The chairman of this meeting requires things for the lab staff: hygiene, order and correction towards all lab devices and equipments 15 At the end of this meeting, a list of need-to-do things with double-check for laboratory staff has been set up, under the supervision of the senior lab technicians TRACK 9: COMPLETE THE TASKS BELOW Task 1: NAME - JOB TITLE MATCHING Gail Webber Charlie Newman Dr Ina Richter Jennifer Kremer A Lab Manager B Internal Auditing administrative C Junior chemical lab technician D Senior chemical laboratory technician 39 Task 2: DECIDE WHETHER THESE STATEMENTS SHOULD BE CLASSIFIED INTO “DO >< DON’T” ACTIVITIES PERFORMED IN THE LABORATORY Eating Smoking Drinking Chatting Wash hands Wear helmets Internet surfing Wear safety gloves Wear special lab coat 10 Wear safety equipment 11 Wear shoes in the laboratory 12 Wear proper protective clothing 13 Wear overshoes in the laboratory 14 Observe all safety rules for the laboratory 15 Wear safety goggles or glasses at fixed times TRACK 11: ANSWER THESE QUESTIONS IN COMPLETE SENTENCES Which problems happen to the dogs? What are the groups of dog involved in the clinical trial? What may be the cause for this problem in dog groups? Which finding related to the rodent group is available? 40 Why are mini-pigs more preferred? What is Roger’s reaction to Jake’s suggestion on mini-pigs? How long have the dogs been treated with the substance? To which factor were the individual doses adjusted? If the main cause were the drug concentration, which proposal is given afterwards? 10 How long would Roger recommend continuing the dose? 11 Which copy does Roger ask Linda to send him after the meeting? 12 How much experience has Miki got with this task? TRACK 12: COMPLETE THE SUMMARY BELOW WITH - OR – – OR – WORD GAPS The details of (1) (2 words) can be found (2) (3 words) of the (3) (2 words) of the documentation One minor problem here is that the (4) illegible because it was not (5) the (6) (2 words) has been made (2 words) with a single line; therefore, (2 words) can not be readable Dr Frensen – (7) (3 words) – is responsible for this mistake despite his (8) (2 words) It is important that (9) (4 words) according to 41 (10) (3 words) standards in order to avoid (11) (2 words) The reason for the changes made in the storage temperature is (12) word) and (13) (1 word): (14) (2 words) showed that the storage temperatures had (15) the original temperature was (16) (1 (3 words) on the substance while (2 words), which led to (17) (2 words) that was outside the (18) (2 words) TRACK 13: CHOOSE THE MOST APPROPRIATE ANSWER FOR EACH QUESTION Which holiday is it? A New Year Eve B Lunar New Year C Halloween D Christmas Eve TM In which form is Mensamint being marketed? A Tablet B Capsule C Cream D Spray Who is Maria? A One company staff B One company’s competitor C One clinical trial participant D One MensamintTM user Which information is INCORRECT? A Maria has totally recovered from her condition C Maria has allergies to peanut and chocolate B Her case is planned to appear on media means of communication D Information from her interviews alone is enough for the company to follow her case How serious is the evidence for Maria’s case? A Reliable B Eligible C Flawless D Ambiguous Which statement is FALSE about Maria’s symptoms? A She was fainted in half an hour B Dementia is her final and official diagnosis C She experiences severe rash all over the body D It was easy for het to get annoyed by any questions from healthcare workers What is the next obstacle for the company? A Approval grant B Staff vacancy C Marketing strategies D Compensation budget 42 Which documentation below has NOT been completed for approval status? A Quality Assurance B Preclinical and clinical data C Patient leaflet and labeling D Environmental risk assessment Why does Karl comment: “That’s good news!”? A There is a connection between MensamintTM and Maria’s symptoms B Patients with hypertension should avoid taking MensamintTM C The side effects Maria experiences are recognized from clinical trials and determined in patient leaflet D MensamintTM prescription insert has clearly state and warn patients with hypertension to avoid taking MensamintTM for severe side effects TRACK 14: ARRANGE THE INFORMATION RELATED TO A PATIENT PRESCRIPTION INTO THE POSSIBLE CORRECT ORDER A Name of product B Possible side effects C Section: How to store D Further information section E Drug administration: How to take/use F Contraindication section: Before you take this product G Indication section: What the product is and what it is used for H Standard warning: Read this leaflet carefully because it contains information you need to know TRACK 15: ANSWER THE FOLLOWING QUESTIONS IN COMPLETE SENTENCES Which department is Henry representing for? When was RRB Pharmaceuticals established? How big was RBB at that time? How has RBB changed? 43 Which pharmaceutical activities are being carried at RRB? Which strict rules towards visitors are being set at this tour? What is the difference in the clothing requirements between the past and the present? What is the disadvantage of wearing three layers of clothing in some production area? TRACK 16: WRITE DOWN ALL THE ACTIVITIES LISTED IN THE AUDIO FILE ………………………………………… ………………………………………… ……………………………………… ………………………………………… ………………………………………………… ………………………………………………………… ……………………………………………… …………………………………………………… …………………………………………………… 10 ……………………………………… 11…………………………………………………… 12………………………………………… 13………………………………………………… 14…………………………………………… 15……………………………………… 16………………………………………… 17……………………………………………… 44 18……………………………………………………… 19…………………………………………… 20……………………………………………………………… TRACK 18: COMPLETE THE SUMMARY BELOW OVERVIEW OF GMP REQUIREMENTS COMPLIANCE AND IMPLICATIONS FOR PHARMACEUTICAL COMPANIES 1st (1) = Following the rules 2nd GMP = (2) = High standard = Follow (3) Example: How to (4) buildings -> The flow (5) -> Can be (6) Optimizing the flow of material = Make sure that (7) Example: Different colors of separate areas -> Ensures adequate (8) and minimizes (9) GMP also covers a Type of clothing (10) b Documentation (11) c Training (12) 45 Authorities check a Time: (13) b Purposes: (14) -> Ensures (15) Validation process a Purpose: To receive (16) b Subjects: (17) & c Frequency: on (18) (once a year) Laboratory technicians a How important are lab technicians? (19) b Duties: Perform (20) c Testing: Shows (21) d Samples: Taken at (22) and checked for (23) THIS IS THE END OF LISTENING EXERCISE 46 [...]... administrative D Clinical trial manager 6 Which information below is INCORRECT about Anna? A Clinical methodology was her research focus B Her license to practice pharmacy was obtained in America C After master graduation, she began to work here 3 years ago D Two other clinical research associates are assisting her with test centers 7 Which information below is NOT included in Walter’s brief introduction?... approximately half the travel time 8 The higher qualifications the candidates achieve, the more likely he or she will be considered for the vacancy 9 Any newly graduates can apply for this job position 10 Mastering FDA as well as EMEA regulations is another requirement 11 Individual working ability is more evaluated than teamwork capacity 12 Clinical trial management does demand communication skills TRACK