HOW CAN AN ADAPTIVE TRAINING PROGRAMME SUPPORT CHANGE IN ORGANISATIONAL STRATEGY? Dr Karine Palin

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1 HOW CAN AN ADAPTIVE TRAINING PROGRAMME SUPPORT CHANGE IN ORGANISATIONAL STRATEGY? Dr Karine Palin Lifelong Learning in the Biomedical Sciences EMBL Heidelberg, Germany Jul 2016

2 LEGAL NOTICE DISCLAIMER This document contains description of the Eu2P project work and management. Certain parts of this document might be under partner Intellectual Property Right (IPR) rules so, prior to using its content please contact the project management team for approval. In case you believe that this document harms in any way IPR held by you as a person or as representative of an entity, please do notify Eu2P project management team immediately. Please contact: eu2p.office@eu2p.org INTELLECTUAL PROPERTY RIGHT The authors of this document have taken any available measure in order for its content to be accurate, consistent and lawful. However, neither the project consortium as a whole nor the individual partners that implicitly or explicitly participated the creation and publication of this document hold any sort of responsibility that might occur as a result of using its content. The Eu2P project is funded by the Innovative Medicines Initiative Joint Undertaking (IMI JU) Neither IMI JU nor the European Union and EFPIA are liable for any use that may be made of the information contained in this document. 2

3 NEED FOR EDUCATION & TRAINING IN DRUG SAFETY IN INDUSTRY, REGULATORY AND ACADEMIC BODIES Adverse events and fatal outcomes of drug use in population Drug surveillance in real life is essential Growing needs of well-trained persons in pharmacovigilance and pharmacoepidemiology Need of skilled persons, specifically trained in risk-benefit assessment, risk management plan elaboration, risk minimisation and risk communication as pharmacovigilance practices and post-licensing evaluation of medicines Need for a pro-active real life training approach Emergence of new job profiles for medicines related stakeholders such as project managers, drug safety coordinators, medicines risk-benefit analysts and collaborators able to interfere with statisticians and clinicians. 3

4 AN ANSWER A PUBLIC PRIVATE PARTNERSHIP TO FILL IN THE GAP OF TRAINING IN DRUG SAFETY Since 1 st Sept to onwards Eu2P is a public-private consortium including 7 academic, 2 regulatory and 15 industry partners. This consortium is coordinated by 4

5 TO DELIVER A FULL ACCREDITED TRAINING OFFER IN PHARMACOVIGILANCE & PHARMACOEPIDEMIOLOGY 25 Academic Certificates 75 h of theoretical course over a 3 months period Introductory to advanced level among 6 different course domains A joint Master degree 1 or 2 years curriculum 750 h of theoretical courses 750 h of project research on job premises 5 available specializations PhD programme 3 years min. of full-time research on job premises 150 h theoretical courses / year On-the-job research projects Joint programme But! people within the pharmaceutical industry do not commonly take a Certificate or Master degree due to the involvement it requires for people having a full time job and who already have a professional diploma such as MD or PharmD. 5

6 Eu2P TRAINEES PROFILES FOR THE 5 LAST YEARS 13% 53% 9% 15% Full-time pace 35% 10% 65% Part-time pace 76% 24% Full Time Professionals Which training offer to comply with professional and company strategy? 6

7 A SOLUTION: FULL ONLINE SHORT COURSES Eu2P short courses are delivered in English, Spanish or French accessible anytime, from anywhere adapted to time availability (on-the-job training) 7

8 SHORT COURSES: BITE-SIZED COURSES ENDORSED BY ACADEMIC PARTNERS 8

9 SHORT COURSE: BITE-SIZED COURSES ADAPTED TO PROFESSIONAL PARTNERS (1) 9

10 SHORT COURSE: BITE-SIZED COURSES ADAPTED TO PROFESSIONAL PARTNERS (2) In real-time, the company can Quantify and analyse the training attendance, workload and quiz results for each employee per course. Report the whole training and results reporting per employee to the company appointed representative(s). Check the training achievement and final quiz result to authenticate the employee training period (equivalent to CPD certificate) 10

11 EACH TOPIC = ONE SHORT COURSE 11

12 Current Eu2P Personalized training offer Discussion with organization training needs 12

13 ONE PROFESSIONAL PROFILE = SEVERAL TAILORED SHORT COURSES 13

14 Building a company personalized training plan According to organization training needs > Creation of job profiles with course interactions between collaborators and teams PV department in a company QPPV Corporate Vigilances Director Local Safety Officer PV auditor Vigilances Officer Head of Vigilances Expertise Unit Cross-Functional Vigilances Expert Specific needs Advanced courses Courses on GVP regulations US regulations & Japanese regulations Courses on Risk Management Plan & Benefit-Risk analyses methods Common needs Introductory courses Courses on Post-Marketing Legislation & Pre-Marketing PV Legislation 14

15 HOW COLLABORATORS ENJOY THIS COMPANY PERSONALIZED TRAINING PLAN? > EXAMPLE WITH ONE PHARMA COMPANY Number of Course Registrations per year In one company, the number of collaborators registered to courses significantly increases each year. 15

16 HOW COLLABORATORS ENJOY THIS COMPANY PERSONALIZED TRAINING PLAN? > EXAMPLE WITH ONE PHARMA COMPANY 80% 70% 60% 50% 40% 30% 20% 10% 0% % Course Successful Rate per year 70% 55% 12% In one company, the rate of success of collaborators when passing the quiz significantly increases each year. 16

17 EXPECTED IMPACT FOR THE ORGANIZATION Expected impact? Increased efficiency within the studied company teams as regards Quality : skilled persons, specifically trained Well-being of collaborators with and between teams Improved communication with and between teams Better understanding and knowledge of competencies of its collaborators Understanding of new needs and natural emergence of new job profiles Facilitation of career development At the end Improvement of Drug surveillance and safety in real life for population 17

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