Unit 1 The Kick-Off Meeting (Technical English )

1. To describe some jobs and departments in a pharmaceutical company. 2. To knowledge the new drug development and launches. 3. To introduce oneself, one’s field, and projects. 4. Grammar: present passive and past passive

Lesson 1: The kick-off meeting

3 To introduce oneself, one’s field, and projects.

4 Grammar: present passive and past passive

Vocabulary Phonetic spelling

5 Research and Development /ˈriː.sɝːtʃ ən dɪˈvel.əp.mənt/

7 QA (Quality Assurance) /ˈkwɑː.lə.t̬i əˈʃʊr.əns/

A kick-off meeting is the first meeting with the project team and the client of the project.

Clinical Affairs deals with all aspects of the clinical application of your medical device.

Marketing and Sales are activities for advertising and

selling products

Production is the process of making or growing goods to

be sold.

Research and Development

(R&D) is the part of

a business that tries to find ways

to improve existing products, and to develop new ones.

Quality Assurance (QA) the things a company does to make sure that its products and services are as good as they should be

a We compound the raw materials into drugs, package them, and put in the leaflets for the patients We also keep careful records

of all the steps in this process.

b We find new substances to make new drug formulations or change existing dosage forms, for example from tablets to capsules.

c We compile the drug documentation and send it to the regulatory drug authorities so

we can get authorization to market the product.

d We plan the promotion and distribution of drugs which will be launched, and make decisions about the packaging or tablet colour of new products.

e We test or organize testing on live subjects, and make sure that our drugs are safe and effective for the patients.

f We ensure that products meet the standards which the law requires, and contain the active ingredients advertised.

Match what they are working and their departments

1 Clinical Affairs

2 Marketing and Sales

Which departments would

you like to work in?

Soft gel capsule

/ sɑːft dʒel ˈkæp.səl/

Analgesic / æn.əlˈdʒiː.zɪk/

Patch

/ pætʃ/

Sugar-coated tablet / ʃʊɡ.ɚˈkoʊ.t̬ɪd ˈtæb.lət/

Fab PharmaceuticalsFrom: Harvey Jones, project manager

To: Heads of departments

Re: 'CoolHead'- Kick-off meeting

Dear colleagues

The main reason I am writing to you today is to remind you that we still need you to propose peoplefrom your departments to work on our new soft gel capsule for headaches and to liaise with yourdepartments As you know, it will be a prescription drug, so people with experience in analgesics arethe ones we'd most like to have on board

Here is an update on the project Since the conclusion of our successful feasibility study, we have alsoobtained very encouraging preclinical data This means that we can soon start with the clinical trialsand are now ready to get the project team together The kick-off meeting will take place on 6 March inthe Intercontinental Hotel More details will follow soon

You are probably aware that 'CoolHead' is just the working name of the new drug The soft gel capsulewill be followed soon afterwards by two other dosage forms also in the pipeline: patches and sugar-coated tablets We plan to launch all of these products in Europe first and to apply for Food and DrugAdministration (FDA) approval in the US the following year

We still need project team members from R&D, Regulatory Affairs, and QA As far as Marketing isconcerned, Carole Marks will be flying in from France She'll give us more information on themarketing claims and a target patient profile From Clinical Affairs in ltaly, Anna Edicola will present theclinical requirements She, as well as Charley Wu from Production, will be connecting with us by videoconference

I'd like to get the team members' names you propose, as well as their contact details, and a brief bio

on each one from you this week Then I can invite them to the meeting Let me know if you foreseeany major difficulties at this stage

Read the memo

1 The most important reason for this memo is to give information about a new drug.

2 Patients who want to buy this drug will not need to see

a doctor first.

United States.

Clinical Affairs are already on board.

Are the following statements true () or false (x)?

Match the term on the left with the definition on the right.

a Medicine bought in a pharmacy and requiring a written note from the doctor.

b Future drugs, not yet on the market.

c The final form of the medicine, e.g tablet, powder, gel, spray, etc.

d An investigation to determine the advantages, practicality, and profitability of a proposed project.

e A product which can be sold without the patient seeing a doctor.

1 I am writing to you is to get your input on

a new product 2, we plan to market a new prescription drug for headaches.

But first, 3 The feasibitity study has just been successfully completed _4

it will be marketed in Europe first 5 your input _ 6, we need the financial data from your department as soon as possible.

The main reason…

You are probably aware that…

As far as…is concerned,…

Here is an update on the project

As you know,…

Insert the expression from the box below in the gaps.

Read the job profiles

When a company starts to test drugs on live

subjects, I work closely with the doctors to make

sure that the studies are done correctly

I operate complex scientific instruments and

perform tests to determine whether ingredients

in liquids, powders, or tablets meet requirements

It's my job to research, write, and edit clinicaland study reports before we submit them toregulatory authorities I summarize and interpretclinicaldata

I collect drug safety information about patients

on our medications I must report any serious adverse events to the health authorities.

a

b

c

d

I co-ordinate and manage the cross-functionalteams that develop and launch a drug lt's noteasy to get people to meet deadlines.

According to European law, I am personallyresponsible for the quality of each product thatleaves the production line I must manage all theprocesses in production, QA, and the labs to

make sure Standard Operating Procedures

(SOPs) are followed.

My job is to make sure that suitable, cleancontainers are used to get the product from thecompany to the patient In general, I check for

compliance with health regulations.

In my work, I develop pharmaceutical dosageforms At the moment, l am changing a tablet

formulation into ointment and gel forms.

e

f

g

h

1 _: taking our medicine

5 _: any health problem which starts

while on a new medicine

6 _: rules or laws about health

7 _: an oily substance like a cream

Match the words in italic with the definitions below.

8 clinical research associate

1 What is the main aim of the meeting?

kick-Academic degrees

 Bachelor‘s degree or bachelor of science degree (BS or BSc)

 Master's degree or master of science degree (MS or MSc)

 License to practise pharmacy

 Doctorate or doctor of philosophy degree in pharmacy (PhD)

Introducing yourself, your field of expertise, and current project.

Introducing yourself, your field of expertise, and current project.

 Introducing yourself

I’m/My name is …

I am from … I’ve been with the company for … years.

I am/I come from … (nationality)

Introducing yourself, your field of expertise, and current project.

 Introducing yourself

 Educational background

My professional background is in …(field).

I got/received/obtained my …(degree) in …(subject).

 Experience

 Expertise

 Describing current work and role in project

Introducing yourself, your field of expertise, and current project.

 Introducing yourself

 Educational background

 Experience

I used to work at (company/institute) in their department.

I then worked for (company/institute) and later for (company/institute).

I started as a (postition) and worked my way up to .(position).

I did research on

 Expertise

 Describing current work and role in project

Introducing yourself, your field of expertise, and current project.

Introducing yourself, your field of expertise, and current project.

 Introducing yourself

 Educational background

 Experience

 Expertise

 Describing current work and role in project

I am the …(position) assigned to this project.

I am responsible for …

I am supported by two …(positions).

We are currently working on …

At the moment, I am working on a project to …

Hi everyone Pleased to meet you all My name is Charley Wu, and I’m the plant manager at our manufacturing plant in Shanghai I was also born and raised in China I first started as line worker and worked my way up to packaging technician I later studied in the UK and got/received/obtained an MSc in Engineering there More recently, I was involved in the initial conceptual design phase, and at present I am responsible for the planning and building of our second new pharmaceutical facility in Shanghai In this new facility we will produce both liquid and solid dosage forms In addition to this, at the moment I am working on a project to build a new analgesics production line, and that is why I was asked to join this project.

Medicines and Drugs differences

Present Passive & Past Passive

Present Passive am/is/are + V3/ed Past passive was/were + V3/ed

Put the following sentences into the present passive

1 Someone washes the trolley with soap and water.

2 Someone then dries the trolleys.

3 Someone gives the patient an injection every morning.

4 Someone discards the disposable equipment after use.

5 Someone mops the trolley with an antiseptic.

Complete the following sentences with the correct past or

present passive forms of the verbs in bracket

1 Mr.Smith (give) _ an injection every four hours.

2 These jobs (do) usually _ by the student nurses.

3 These instruments (need) _ for surgical dressings.

4 She (ask) to go on duty at 6.30 am yesterday.

5 Those instruments (discard) yesterday.

Change these sentences into passive

1 The pharmaceutical company produced a new drug.

Put the words in the right word order to make sentences.