programme 17-21 june, 2012 barcelona, spain - europa · programme 17-21 june, 2012 barcelona, spain...

EURORDIS SUMMER SCHOOL

FOR PATIENT ADVOCATES

IN CLINICAL TRIALS AND DRUG DEVELOPMENT

Programme

17-21 June, 2012

Barcelona, Spain

Organisers:

Dr. Maria Mavris Sharon Ashton Fundació Dr. Robert Therapeutic Development Director Senior Events Manager Iolanda Arbiol [email protected] Helena Garrigos

A capacity building programme for patient representatives

involved at the European level in the development, approval,

information and access to orphan drugs, paediatric drugs and

advanced therapies

Developed with the support of:

Sponsored by:

www.eurordis.org

20113212_D06-00_OTH_EN_PS.pdf B.3.c.2. EURORDIS Summer School 2012 - Annex 1 Programme Summer School 2012 -




PLANNING OVERVIEW FOR SUMMER SCHOOL

BARCELONA, SPAIN

Welcome Dinner

Day 1

Life cycle of Drug Development

Principles of clinical trials

Day 2

Ethics

Post-marketing phases

Day 3

Regulatory committees and working parties at

the European Medicines Agency

Day 4

Regulatory committees cont…

ECRIN project

EURORDIS activities





Monday June 18 Day 1

9:00-9:30 EURORDIS and Fundacio Dr. Robert

Welcome Address and introduction to Summer School

9:30–10:15 Small group discussions using session 1 material provided

10:15-11:00 Dr. Markku Toivonen

Clinical Research Need for evidence-based medicine Life cycle of drug development from pre-

clinical (specificity of orphan medicinal products)

Diagram demonstrating stages of drug development.

11:00-11:30 Coffee break

11:30-12:15 Small group discussions using session 2 material provided


Methodology principle in clinical trials Concepts and vocabulary The ‘Gold Standards’

Controlled Blind Randomised

• Small populations

13:30-14:30 Lunch

14:30-16.30 Ms. Julia Saperia

Methodological principles Concepts and vocabulary Statistical significance Clinical significance p value Statistical power Statistical risks

PROGRAMME





Tuesday June 19 Day 2

9:00-9:30 Group discussions using session 4 material provided

9:30-11:30 ds Eric Koster MA/ Mr Rob Camp

Ethical aspects Concepts and vocabulary Therapeutic v Experimental situation Consent for participation


12:00-12:30 Group discussions using session 5 material provided


Regulatory procedures Importance of Post-Marketing phases Compassionate use Accelerated review Conditional Approval Marketing Authorisation under

exceptional circumstances Risk management plans

13:30-14:30 Lunch

14:30-16:00 All trainers Presentation of EURORDIS Training

Resources section Open discussion

PROGRAMME

Cocktail evening at hotel Alimara





Wednesday June 20 Day 3

9:00-9:30 Dr. Juan Garcia Burgos General Introduction to the European Medicines Agency

9:30-10:00

Dr. Juan Garcia Burgos Committee for Orphan Medicinal Products (COMP)

10:00-11:00 Mini-COMP sessions in small groups


11:30-12:00 Prof. Josep Torrent Farnell

Committee for Medicinal Products for Human Use (CHMP)

12:00-12:45 Mr. François Houÿez Patients’ and Consumers’ Working Party (PCWP)

12:45-14:00 Lunch

14:00-16:00 Dr. Juan Garcia Burgos Training on Review of Product Information - workshop

PROGRAMME

Tour of Cosmo Caixa museum





Thursday June 21 Day 4

9:00-9:30 Dr. Fernando de Andres-Trelles Paediatric Committee (PDCO)

9:30-10:30 Mini-PDCO sessions in small groups

10:30-11:00

Coffee break

11:00-11:30

Dr. Michele Lipucci di Paola Committee for Advanced Therapies (CAT)

12:00-12:30

Prof. Josep Torrent Farnell Scientific Advice Working Party (SAWP)

12:30-13:30

Lunch

13:30-14:00

Dr. Christine Kubiak Presentation of ECRIN project

14:00-14:30

Mr. Rob Camp EURORDIS Clinical Trials Best Practise and demonstration of EUCTR – Clinical Trials Register

14:30-15:30

Open discussion and Closing of Summer School

PROGRAMME



A capacity building programme for rare disease patient representatives involved at the European level in the

development, approval, information and access to orphan drugs, paediatric drugs and advanced therapies

Developed with the support of:

Sponsored by:

www.eurordis.org

EURORDIS Summer School for Patient Advocates in Clinical Trials and Drug Development

Barcelona, Spain - June 17-21, 2012

For more information, contact:

[email protected]

20113212_D06-00_OTH_EN_PS.pdf B.3.c.2. EURORDIS Summer School 2012 - Annex 2 Flyer Summer School 2012 - Page 1

mailto:[email protected]




JUNE 17- 21, 2012

BARCELONA, SPAIN

Welcome Dinner

17 June

Day 1

18 June

Life cycle of Drug Development

Principles of clinical trials

Day 2

19 June

Drug Development in non-standard situations

Post-marketing phases

Day 3

20 June

Regulatory committees and working parties at

the European Medicines Agency

Day 4

21 June

Regulatory committees cont…

EURORDIS Charter and

Task Forces

www.eurordis.org

20113212_D06-00_OTH_EN_PS.pdf B.3.c.2. EURORDIS Summer School 2012 - Annex 2 Flyer Summer School 2012 - Page 2

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20113212_D06-00_OTH_EN_PS.pdf B.3.c.2. EURORDIS Summer School 2012 - Annex 3 List of Participants - Page 1

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20113212_D06-00_OTH_EN_PS.pdf B.3.c.2. EURORDIS Summer School 2012 - Annex 3 List of Participants - Page 2

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Eurordis Summer School Barcelona, June 17 - 21, 2012

Training Rare Disease Patient Advocates in Clinical Trials and Drug Development

Application Form (only completely filled forms will be considered)

1. Your contact details

First name Last name

E-mail Telephone

Address Postal code

City Country

2. Your organisation

Name:

Disease(s) represented:

E-mail Website

Telephone Fax

Address Postal code

City Country

3. Your role in the patient organisation

Are you? Please tick

Patient Staff

Parent of patient Volunteer

How long have you been active in the organisation? What are your roles or activities? (10 lines max)

Do you represent your organisation in any European Committee/Task Force/ Working Group? If yes, please specify

What is your professional background? (10 lines max.)

4. English language skills Please mark 1 to 5 for competence, where 5 is the highest English Speaking: Writing: Reading:

5. Your experience/knowledge (5 lines max.) Please describe your past and current involvement (if any) in clinical trials and drug development:

20113212_D06-00_OTH_EN_PS.pdf B.3.c.2. EURORDIS Summer School 2012 - Annex 4 Application Form - Page 1

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6. Drug Development (10 lines max.) Please describe your past or potential drug development collaborations with research groups, pharmaceutical companies or actions for the development of drugs in your rare disease.

7. Expectations (10 lines max.) Please describe your expectations related to this summer school and how you think this training will help you in your activities.

8. Commitment

Please evaluate your level of commitment to potentially be involved in clinical trial and drug development policies and procedures, to share knowledge and exchange experience and to represent rare disease patients at the national and European level. If I’m selected to attend the Eurordis Summer School 2012: [ ] I agree to attend the full 4-day programme [ ] I agree to be included in Eurordis list of potential volunteers so as to act as a rare disease patient representative for activities related to clinical trials and drug development. As part of the Eurordis list, I agree to: [ ] Share my knowledge [ ] Share my experience [ ] Be appointed as “patient expert” in particular for meetings at the EMA such as Protocol Assistance for my disease or review of European Public Assessment Reports [ ] to review Eurordis’ position papers, contributions and statements for advocacy purposes in the clinical trial and drug development area [ ] Participate in other conferences and workshops [ ] I am interested in attending future capacity building sessions and seminars in orphan drug development organised by Eurordis or third parties in conjunction with Eurordis.

Signature Date

Please fill out this form and send it back to [email protected] or fax +33 1 56 53 52 15

20113212_D06-00_OTH_EN_PS.pdf B.3.c.2. EURORDIS Summer School 2012 - Annex 4 Application Form - Page 2

mailto:[email protected]

20113212_D06-00_OTH_EN_PS.pdf B.3.c.2. EURORDIS Summer School 2012 - Annex 5 Summer School Webpage - Page 1

20113212_D06-00_OTH_EN_PS.pdf B.3.c.3. EURORDIS e-learning - Annex 1 Online e-learning tool - Page 1

programme 17-21 june, 2012 barcelona, spain - europa · programme 17-21 june, 2012 barcelona, spain...

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