Welcome to the Open Day! NUSAGE - PAREXEL Postgraduate ... Open Day... · An Early Clinical Trial...
Transcript of Welcome to the Open Day! NUSAGE - PAREXEL Postgraduate ... Open Day... · An Early Clinical Trial...
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Welcome to the Open Day!
NUSAGE - PAREXEL Postgraduate Certificate in Good Clinical Practice
Heidrun Bruchmann, PhD Director, PAREXEL Academy
© 2010 PAREXEL International | Confidential
Who we are
Dr Heidrun Bruchmann Director
Valerie Howarth-Gruender Course Coordinator Lecturers:
Dr Matthias Grossmann The Drug Development Process
Bettina Merz-Nideroest/ Regulatory Affairs Dr Edmund Leong
Claudia Richter Conducting Clinical Research
Dr Sabine Brunschoen-Harti Client Relationship Management
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Topics
1. PAREXEL International 2. PAREXEL Academy 3. Course Structure 4. Selection of Students 5. Module 1: The Drug Development Process 6. Module 2: Regulatory Affairs 7. Module 3: Conducting Clinical Research 8. Module 4: Client Relationship Management 9. Assessments/Marking System 10. Work Placement 11. Career Opportunities 12. Questions?
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South Africa (3)
Mexico
Japan (3) Israel
India (2)
United States (17) California
Connecticut Illinois
Maryland Massachusetts
New Jersey North Carolina
Pennsylvania Virginia
China (4) Hong Kong Indonesia S. Korea Malaysia Philippines Singapore Taiwan Thailand
Australia
Ukraine (2) United Kingdom (6)
Argentina Brazil Chile Peru
PAREXEL International
PAREXEL has more than 10,850 employees worldwide
located in 72 offices throughout 38 countries. (Figures as of Sept 2011)
South Africa (3)
Israel
United States (17) California
Connecticut Illinois
Maryland Massachusetts
New Jersey North Carolina
Pennsylvania Virginia
China (4) Hong Kong Indonesia S. Korea Malaysia Philippines Singapore Taiwan Thailand Vietnam
Belgium Croatia Czech Republic Denmark Finland
France (2) Germany (3) Hungary Italy Lithuania
Netherlands Poland Romania Russia (2) Spain
Argentina Brazil Chile
Colombia Peru
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PAREXEL Academy - Background
Founded: 2001 in Berlin (Germany/Europe)
Objective: To provide high quality training for newcomers and professionals in the biopharmaceutical and contract research industry.
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Postgraduate
Courses
Bachelor of Science
in Clinical Research
(BSc)
Training for the
Pharma- ceutical Industry
Tailored In-house Training for Pharmaceutical Companies
Validated by the University of Wales, since 2008
GCP-Training for
Site Staff
Japan Oncology Academy
Internal Training for PAREXEL CRAs
1. Study Nurse Training
2. Investigator Training
PAREXEL Academy
PAREXEL Academy – What we do
1. Clinical Research Associate/Clinical Trial Management, PAREXEL Academy Germany, since 2002
2. Certificate in GCP in cooperation with the National University of Singapore, Feb 2012
3. Cooperation with
Northeastern University Boston in process
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Who we teach
Over 1700 participants in all courses to date 680 Study Nurses 280 Investigators 443 Postgraduates 54 Undergraduates Several hundred professionals from pharmaceutical
companies
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Postgraduate Courses – Proven Success
443 graduates have completed our courses 92% of all graduates were placed 50% received job offers before the end of the course
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Postgraduate Courses
239 started work in these departments at PAREXEL Monitoring/Clinical Operations 118 Clinical Logistics 64 Data Management 42 Study Start-Up Unit 27 Project Management 13 Medical Services 22 Regulatory Affairs 17 Peri-Approval Studies 5 Proposal and Contracts 4 Perceptive Informatics 3 Quality Assurance 2 Biostatistics 1 Medical Writing 1
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170 graduates started work at other companies
Pharmaceutical Industry:
Contract Research Organisations:
Institutes:
Astra-Zeneca Bausch&Lomb Biotronik Bayer Boehringer-Ingelheim Boots Grünenthal Merck Novartis Pfizer Roche Pharma Sanofi-Aventis Solvay Schwarz Pharma/UCB Stada NovoNordisk
Quintiles Covance PRA Int. I3 Research Icon PPD Accovion Clin Research Cologne Ecron Entimo Berlin GSO Hamburg Omnicare Synarc Hamburg
BfArM Helios Kliniken Trial Coordinating Units in Hospitals or Universities University of Marburg
Postgraduate Courses
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COURSE OVERVIEW
Valerie Howarth-Gruender, BA, PGCE, RSA Dip
Course Coordinator Senior Trainer PAREXEL Academy
© 2010 PAREXEL International | Confidential
The Postgraduate Certificate Program Details
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Qualification Postgraduate Certificate in Good Clinical Practice Course structure 4 modules taught sequentially Delivery One week full-time face-to-face training (30 hours)
One week self-directed learning (30 hours) Academic value 4 x 4 Modular Credits (MC) = 16 MC (24 ECTS) Course length 10 weeks: 8 teaching weeks 1 revision week 1 examination week Assessment A 2-hour written examination for each module. Faculty Lecturers from PAREXEL Academy and NUS Venue Department of Pharmacy, Faculty of Science National University of Singapore
Course Structure
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Selection Procedure
Prerequisites Bachelor degree in Medicine, Pharmacy, Life Sciences or related major. IELTS 7.0 or TOEFL equivalent (language requirement waived for applicants
who have completed their studies in English) Application procedure Online application form on NUSAGE website Selection procedure Assessment Centre comprising: Interview Aptitude test Communication skills test
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Course schedule
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Week 1 07 May 2012 Drug Development Process 30 hrs contact
Week 2 14 May 2012 30 hrs directed learning
Week 3 21 May 2012 Regulatory Affairs 30 hrs contact
Week 4 28 May 2012 30 hrs directed learning
Week 5 04 Jun 2012 Conducting Clinical Research 30 hrs contact
Week 6 11 Jun 2012 30 hrs directed learning
Week 7 18 Jun 2012 Client Relationship Management 30 hrs contact
Week 8 25 Jun 2012 30 hrs directed learning
Week 9 02 Jul 2012 Timetabled Revison Sessions
Week 10 19 Jul 2012 1 x 2-hour examination per day
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THE DRUG DEVELOPMENT PROCESS
Matthias Grossmann, MD, PhD
Clinical Pharmacologist Pathophysiologist
Vice President and Principal Consultant Trainer PAREXEL Academy
© 2010 PAREXEL International | Confidential
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History of Drug Development
Before 1800 use herbal remedies
After 1850 isolate the active principle understand symptoms of a disease
After 1920 recognize the cause of a disease (insulin, penicillin) discover putative target
After 1970 understand immunology and genetics produce human-specific compounds/biologicals
After 2000 an era of individualized medicines?
Drug Development: Success Rate
• Only 1 out of 50 drug candidates reaches clinical testing
• Only 1 out of 5 of these drug
candidates reaches the market
• Clinical development is twice
as expensive as candidate selection
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Learning Too Little Too Late
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Preclinical Phase IIb Phase III Phase IV Phase I-IIa
KNO
WLE
DGE
TIME / MONEY
Market Withdrawal!
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Learning Too Little Too Late
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Preclinical Phase IIb Phase III Phase IV Phase I-IIa
KNO
WLE
DGE
TIME / MONEY
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Orloff and Stanski 2009
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Drug Development
is expensive time consuming often fails time is limited due to patent expiration good planning is of paramount importance Good planning needs good understanding…
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REGULATORY AFFAIRS
Bettina Merz-Nideroest, MPharm
Pharmacist Senior Clinical Trial Specialist CTS
Trainer PAREXEL Academy
© 2010 PAREXEL International | Confidential
An Early Clinical Trial
Dr. James Lind and Scurvy Royal Navy Surgeon aboard HMS Salisbury Scurvy: disease caused by deficiency of Vitamin C
20th May 1747 12 scorbutic sailors divided into six pairs
1) a quart of cider daily 2) 3 x 25 drops of elixir of vitriol (sulfuric acid) 3) two spoonful of vinegar three times a day 4) half a pint of sea-water 5) two oranges and one lemon 6) a spicy paste (garlic) plus barley water
Group 5 experienced a remarkable recovery
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Conduct of Clinical Trials
Would it still be possible nowadays to conduct the study as Dr. Lind did in 1747?
What are the requirements for starting and conducting a Clinical Trial?
What guidelines and laws must be followed?
Who are the key players in clinical research?
What are their roles and responsibilities?
What documents are essential?
Regulatory Affairs Module!
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Clinical Research
Roles Responsibilities
Ethics Competent Committee Authority Investigator Sponsor CRO Trial Subject
Legal Framework Processes Documents 11/30/2011
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CONDUCTING CLINICAL RESEARCH
Claudia Richter
MSc in Medical / Nursing Education Senior Clinical Research Associate Senior Trainer PAREXEL Academy
© 2010 PAREXEL International | Confidential
Process of a Clinical Trial
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What Happens on Site?
We will discuss and answer the following questions: How are patient safety and data integrity assured in
Clinical Trials?
What does a Clinical Research Associate (CRA) have to do and why?
Why is it so interesting to work with site staff in Clinical Trials?
What are the challenges for a CRA in Clinical Trials?
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CRA - Responsibilities and Interactions
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CRA
Investigators and site staff
Client (Sponsor)
Other functional
groups Vendors
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CLIENT RELATIONSHIP MANAGEMENT
Sabine Brunschoen-Harti, PhD
Scientist Director Operations Process, Quality & Training
Trainer PAREXEL Academy
© 2010 PAREXEL International | Confidential
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Client Relationship Management
We will examine the following topics: Managing studies with special requirements
The importance of good communication
Good document practice requirements
Preparing for audits and inspections
Detecting and managing non-compliance and fraud
The Importance of Good Communication
During study visits Addressing quality issues Clarifying issues Good Documentation Practice Requirements Data, documents, signatures Advanced Monitoring Visit Report Writing Addressing the requirements of ICH/GCP Meeting client expectations Meeting regulatory requirements
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Quality Control
Identifying, managing and dealing with: poor performance non-compliance fraud
Audits and Inspections Preparation with site Communication with investigators Communication with inspectors Do’s and Don’ts… Common Findings
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Assessment and Marking
Assessment 1 x 2-hour written exam per module 1 exam per day during exam week at the end of the course All exams a mixture of multiple choice, short answer and
case study questions
Marking The Postgraduate Certificate is marked according to the UK marking system: 70% and over Distinction 60% - 69% Merit 40% - 59% Pass
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Work Placement at PAREXEL
Optional Bonus: 6-month work placement All students guaranteed interviews Takes place at the end of the course Approx. 6 months July to December 2012 Paid at local rates APAC region Testimonial on completion Job interview in 5th month for full-time position
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Assessments and
Selection of Candidates
for the PG Certificate
Program in GCP
Students complete the PG Certificate
Program
Students apply for
placements
Interns perform 6-month
Work Placement
Selection interviews during 5th
month
Hiring of
interns for full-time positions
The Work Placement Process
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Criterion: English speaking environment Suggested countries (others can be added):
Korea* China* Australia India Singapore Hong Kong Taiwan* Japan*
* Locations will need local language capability
Locations
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PAREXEL International: Monthly payment according to local pay practices
Students: Travel costs to/from placement Accommodation Visa fees (if applicable)
Who Pays For What
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Clinical Research Associate, Clinical Monitor, Clinical Monitoring Associate, Clinical Trial Monitor, Clinical Research Specialist, Clinical Research Assistant, Field Based Monitor, Medical Writer, Drug Supply Manager, Clinical Site Manager, Clinical Trial Assistant, Study Coordinator, Clinical Research Coordinator Clinical Study Manager, Clinical Manager, Clinical Research Manager, Director Clinical Research Management, Clinical Project Scientist, Project Management Assistant, Clinical Project Manager, Medical Field Manager, Clinical Trial Manager, Clinical Scientist, Drug Safety Manager, Data Entry Assistant, Clinical Writer, Manager Drug Regulatory Affairs, Regulatory Specialist, Head of Drug Safety, Regulatory Affairs Manager, Manager Drug Safety, Data Manager, Database Manager, Clinical Data Manager, Clinical Programmer, Clinical Data Associate, Database Administrator, Senior Clinical Data Coordinator, Line Manager, Medical Service Liaison Manager, Field Application Specialist Molecular, Clinical Trial Specialist
Possible Careers in Clinical Research
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Any questions?
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