Training and networking event For internship mentors and promoters - - PDF document

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Training and networking event

For internship mentors and promoters of theses In drug development, Pharmaceutical Sciences

January 21, 2020

Team

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Contacts today’s events

• Prof. Paul Declerck

Academic coordinator

Introduction internship 3rd bachelor Internship in drug development 2nd master

Faculty of Pharmaceutical sciences 3

• Apr. Karlien Van Heuverswyn

Faculty coordinator

Introduction internship 3rd bachelor Internship in drug development 2nd master

• Mrs. Ann Verhulst

Administration

Introduction internship 3rd bachelor Internship in drug development 2nd master

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Team master’s thesis

• Prof. Paul Declerck

Coordinator

• Prof. Deirdre Cabooter
• Prof. Guy Bormans
• Prof. Guy Van den Mooter
• Prof. Myriam Baes

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Programme

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Programme

1.00 PM Sandwich lunch 2.00 PM Presentation: Goals internship Goals master thesis 2.45 PM Panel discussion: Combining thesis and internship expectations 3.30 PM Coffee break 4.00 PM Sharing good practices: Evaluation student Feedback student 4.45 PM Suggestions 5.15 PM Reception Networking dinner

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Programme

1.00 PM Sandwich lunch 2.00 PM Presentation: Goals internship Goals master thesis 2.45 PM Panel discussion: Combining thesis and internship expectations 3.30 PM Coffee break 4.00 PM Sharing good practices: Evaluation student Feedback student 4.45 PM Suggestions 5.15 PM Reception Networking dinner

Master in

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Patient Treatment

Communication

Evidence Usage Drug Discovery Registration Analyse

Development

Production Quality

Drug Development Pharmaceutical Care

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Introduction internship 2nd bachelor + return day Introduction internship 3rd bachelor + return day

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Master track decision

Master in Drug Development

Student profile Programme

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Master in Drug Development – student profile

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Patient Treatment

Communication

Evidence Usage Drug Discovery Registration Analyse

Development

Production Quality

Student profile

• Being fascinated in discovery and development of

drugs

• Interested in research in drug discovery
• Aiming to be an expert in drug development

Skills of an expert in drug discovery/development :

• (Industrial) drug production
• Analytical tools
• (Statistical) modeling
• (Non-)clinical studies: design and control
• Registration and reimbursement: background and administration
• Market access
• Pharmacovigilance

Focus on drug development (Interdisciplinary) collaboration

Competences

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Master in Drug Development

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Master in Drug Development – after graduation

• Expert in
• Drug design and drug development
• (Biomedical) Research
• Health care policy
• ‘Qualified Person’
• MaNaMa ‘Industrial Pharmacy’
• Job in education or government

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• Drug Life Cycle
• Interactive lectures
• Flipped classroom
• Drug life cycle project
• Project
• Team

Drug Discovery and Design Non-clinical Research and Development Clinical Research and Development Market Access

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Master in Drug Development – programme year 1

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• Pharmaceutical Biotechnology
• Toxicology
• Health Economics
• Drug Formulation and Compounding II
• Drug Compounding
• Pharmaceutical Technology
• Analytical Tools for Drug Development
• Chromatography, Mass Spectrometry, …
• Statistical modeling
• Perspectives on Religion and Meaning

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Master in Drug Development – programme year 1

• Drug Discovery and Advanced Therapeutic Approaches
• Drug Discovery from Target to Design
• Advanced Biotherapeutics, Pharmacogenomics and Precision Medicine
• Non-clinical and Clinical Research and Development
• Advanced Drug Development
• Pharmaceutical Commercialisation
• Regulatory Affairs & Market Access
• Pharmaceutical Marketing and Management

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Master in Drug Development – Specialisation tracks

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Topics in

• Economics, Management, Organisation and Quality
• Pharmaceutical and Biomedical Research
• Pharmaceutical Care
• Education
• Man and Society

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Master in Drug Development – elective courses

• Patent Law
• Ethics in Pharmaceutical Industry
• Master thesis
• Internship

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Master in Drug Development – programme year 2

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Master thesis and internship

towards a symbiotic interaction Master thesis

• In pharmaceutical industry
• R&D, Regulatory Affairs, Pharmacovigilance, Quality, Market Access, Clinical Trials, …
• In academic laboratory
• Project is hypothesis-based, leads to a particular “masterpiece”
• National and/or international
• In parallel with internship

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Master in Drug Development – programme year 2

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Internship

• In pharmaceutical Industry
• R&D, Regulatory Affairs, Pharmacovigilance, Quality, Market Access, Clinical Trials, …
• In academic laboratory
• Focus on general aspects, operational aspects
• National and/or international
• In parallel with thesis

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Master in Drug Development – programme year 2 Master thesis

• Complex “problem”; in depth study
• Integration of acquired skills, knowledge, competences
• Independence
• Literature research, background
• Finding a solution to the problem
• Evaluation based on
• Process (by promoter)
• Presentation (by promoter and jury members)
• Defence (by promoter and jury members)

More information: https://onderwijsaanbod.kuleuven.be/syllabi/n/K09M7AN.htm#activetab=toelichting_werkvorm_idm1485488 Faculty of Pharmaceutical sciences 22

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• Deals with all domains relevant to Drug Discovery and Development
• Application of acquired skills and theoretical knowledge in practice
• Being trained in the field as a (future) employee
• A challenge in an academic context
• Evaluation
• Portfolio
• Exchanging experiences with peers
• Process evaluation by mentor

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Internship

More information: https://onderwijsaanbod.kuleuven.be/syllabi/n/K09L5AN.htm#activetab=doelstellingen_idp540272

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Timeline

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Timeline

Subject to changes 2020

today nov dec 2020 feb mrt apr mei jun jul aug sep Info session thesis - internship

11/22/2019 Training – networking event mentors 1/21/2020 Deadline project proposals 2/28/2020 Students’ choice 3/24/2020 Allocation 4/3/2020 Deadline intake 6/1/2020 Pre-start internship 7/13/2020 Start internship 9/14/2020

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SCONE

Student Career Online NEtwork

https://gbiomed.kuleuven.be/scone Internship

• Supervisor*
• Mentor

Master thesis

• Promoter* (final responsible)
• Academic promoter* (safeguards merely the academic approach)
• (Co-promoter)

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SCONE

*required

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https://gbiomed.kuleuven.be/scone

• Agreements (including safety/health file)
• To sign once for all future interns
• Uploading project proposals
• Students’ priority list
• Online tool for allocation
• (Intermediate) evaluations

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SCONE

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Agreement

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Safety/health

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Uploading project proposals

You will receive an email from SCONE this Friday or you can click on ‘my offer’

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Uploading project proposals

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Uploading project proposals

You can fill out every step in both languages (Dutch/English)

• Title*
• Number of students (for this subject)*
• Short description/abstract
• Keywords
• Website
• Applied techniques
• Key publication
• Comments/practical information
• Preferred language for communication

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Uploading project proposals

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Uploading project proposals

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(Intermediate) evaluations

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Programme

1.00 PM Sandwich lunch 2.00 PM Presentation: Goals internship Goals master thesis 2.45 PM Panel discussion: Combining thesis and internship expectations 3.30 PM Coffee break 4.00 PM Sharing good practices: Evaluation student Feedback student 4.45 PM Suggestions 5.15 PM Reception Networking dinner

Panel discussion

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Sharing experiences

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• Curd Lejaegere

Daiichi Sankyo

• Kristl Vandenbussche

Infarama

• Johan Nicolaï

UCB

• Veerle Kempeneers

Pfizer

• Jens Van den Abeele

J&J

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Our panel

• Company? Team?
• How to combine master thesis and internship?
• How do you interpret ‘research’ during the master thesis?
• How does the company benefit from the student / master thesis?

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Opinion/experience combining thesis - internship

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The broad concept of ‘internship’

• How to introduce the student to different departments?
• Which tasks are relevant for the student?
• How to vary in tasks?

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Intern as team member

• How is an intern different to a new employee?
• How much independency or responsability do you give to an intern?

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Programme

1.00 PM Sandwich lunch 2.00 PM Presentation: Goals internship Goals master thesis 2.45 PM Panel discussion: Combining thesis and internship expectations 3.30 PM Coffee break 4.00 PM Sharing good practices: Evaluation student Feedback student 4.45 PM Suggestions 5.15 PM Reception Networking dinner

Coffee Break

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Start next session: 4.00 PM

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Programme

1.00 PM Sandwich lunch 2.00 PM Presentation: Goals internship Goals master thesis 2.45 PM Panel discussion: Combining thesis and internship expectations 3.30 PM Coffee break 4.00 PM Sharing good practices: Evaluation student Feedback student 4.45 PM Suggestions 5.15 PM Reception Networking dinner

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Sharing good practices

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Sharing good practices How to evaluate my intern and give feedback?

Training and networking event for mentors of internships and theses in drug development 21 January 2020 4.00 p.m. – 4.45 p.m. Ine Rens (Educational Development Unit, KU Leuven)

Sam is an intern at a department of pharmacovigilance. For his internship he participates in current affairs that fall within the daily work

• f this department (e.g. document and follow up all kinds of ‘complaints’ about

products). He interacts with various other departments, for example to find out the origin of these complaints. The subject of his master thesis concerns the search for a proposal for

• ptimization of this process, based on the experience he gains and a thorough

evaluation of the current process. Again, he interacts with other departments,

• ften the same as the ones he interacts with for his internship.

Emily supervises the internship and is the “industrial” promoter of the master thesis.

A case: Sam (student) & Emily (supervisor)

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You cannot talk about evaluation and feedback …

… without talking about the learning goals.

Internship

During the internship, the student acquires theoretical knowledge and practical experience in the functional domain of a Master of drug development, employed in a pharmaceutical company

• r research context. This includes

development and production of drugs, quality, development of compounding forms, clinical research, experimental and clinical pharmacology, registration of medicines, regulatory affairs and marketing responsibilities, stating the main professional fields. The student will acquire ample relevant experience and will demonstrate that (s)he has acquired the skills and competences required for the degree of master of drug development. (ECTS) The master thesis requires the student to make creative use of theoretical and practical knowledge, skills and competences acquired in other courses, and the capacity to independently search for new information in scientific literature and use it to come to a solution.

Learning goals

Master thesis  PROFESSIONAL COMPETENCES  ACADEMIC COMPETENCES

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1. Start with the end in mind: discuss the learning goals and evaluation criteria from the start with your intern, and make the expectations explicit.

Emily has an intake with Sam about the learning goals for his internship. They discuss the evaluation form that will be used and the pre-defined criteria, and Emily makes clear what she expects from him. A second intake, this time on the master thesis, takes place with Emily, Sam and the academic promoter. They discuss the learning goals, and again, make clear what the expectations are. Emily and Sam agree that during every feedback moment they will use two distinct evaluation forms: one with the goals and criteria for the internship, one with the goals and criteria for the thesis.

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Externally

• bservable
• utcomes

External feedback Internal process to student

TASK

Nicol, D. J., & Macfarlane-Dick, D. (2006). Formative assessment and self-regulated learning: a model and seven principles of good feedback practice. Studies in Higher Education, 31(2), 199-218. doi:10.1080/03075070600572090

“Feedback is a crucial way to facilitate students’ development as independent learners who are able to monitor, evaluate, and regulate their own learning, allowing them to feed-up and beyond graduation into professional practice.” (Evans, 2013)

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2. Towards committed, responsible and effective learners: involve students in the feedback process

During the first half of the internship, Emily asks Sam to prepare their two- weekly meeting with a self-assessment in which he indicates his performance on the different criteria with illustrating examples. Emily then gives feedback on this self-assessment by giving her point of view and they agree on possible actions for the upcoming weeks. During the second half of the internship, Emily asks Sam to formulate 1-2 feedback questions before every two-weekly meeting in which he indicates on what aspects he wants feedback.

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FEED UP

FEED BACK FEED FORWARD

Hattie, J., & Timperley, H. (2007). The power of feedback. Review of Educational Research, 77(1), 81-112. doi:10.3102/003465430298487

3. Effective feedback = feed up + feed back + feed forward

Every feedback moment of Emily and Sam is based on the list of learning goals (feed up) on which Sam indicates how he is doing (feed back). Emily, during the meeting, gives her point of view and discusses with Sam whether she agrees or not on his points of feedback (feed back). She gives more explanation about the expectations when they are not yet clear enough (feed up). At the end they agree on possible actions in which Sam can apply the comments and feedback (feed forward).

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• Transparency – the student knows how he will be evaluated, and how to

prepare for it

What are the evaluation criteria? How can we define ‘excellent’ or ‘moderate’? What is the difference between 14 or 16? Who will evaluate? What is the role of the promoter, the academic promoter …?

Quality in evaluation?

• Transparency – the student knows how he will be evaluated, and how to

prepare for it

• Reliability – the evaluation is consistent

How do you make sure that the subject of the master thesis doesn’t influence the evaluation? Are there any random factors influencing the evaluation? How can they be eliminated from the evaluation?

Quality in evaluation?

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• Transparency – the student knows how he will be evaluated, and how to

prepare for it

• Reliability – the evaluation is consistent
• Validity – the evaluation is aligned with the learning goals

How do you collect evidence on the student’s performance? Does this evidence reflect the learning goals?

Quality in evaluation?

4. Evaluation = transparent, valid, and reliable

To ensure the validity of the evaluation, Emily and Sam have separate feedback moments for the internship and the master thesis, and they use distinct evaluation forms. To evaluate Sam’s professional competences, other ‘evidence’ is collected than for his academic competences. For his professional competences, Emily collects feedback from co-workers on his attitude in the workplace, has a look at the work he has done, checks his knowledge of certain processes, and so on. For his academic competences, Emily asks Sam about his research process, how he has consulted scientific research, the different steps he took in collecting the results, …

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1.Start with the end in mind 2.Towards committed, responsible and effective learners

• 3. Effective feedback = feed up + feed back + feed

forward

• 4. Evaluation = transparent, valid and reliable
• 5. …

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Thank you!

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Programme

1.00 PM Sandwich lunch 2.00 PM Presentation: Goals internship Goals master thesis 2.45 PM Panel discussion: Combining thesis and internship expectations 3.30 PM Coffee break 4.00 PM Sharing good practices: Evaluation student Feedback student 4.45 PM Suggestions 5.15 PM Reception Networking dinner

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Programme

1.00 PM Sandwich lunch 2.00 PM Presentation: Goals internship Goals master thesis 2.45 PM Panel discussion: Combining thesis and internship expectations 3.30 PM Coffee break 4.00 PM Sharing good practices: Evaluation student Feedback student 4.45 PM Suggestions 5.15 PM Reception Networking dinner

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Thank you

for your engagement for being a mentor for your contribution in training tomorrow’s graduates for participating at this event

Walking dinner and networking in “Foyer O&N 4”