TOPRA MSc/Diploma Module 10 Management in Regulatory Affairs

Transcription

1 TOPRA MSc/Diploma Module 10 Management in Regulatory Affairs Liz Gifford, Director, Global Regulatory Affairs, Eisai Ltd ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION 1

2 Learning Outcomes To understand the skills needed to set up and run a successful Regulatory Affairs department 2

3 In this presentation we will cover Building the Regulatory Affairs department structure Managing resources, including time, staff and budget Preparation for meetings, audits, inspections Measurement of performance of the RA department 3

4 Congratulations, you ve got the job... What am I responsible for? What are my objectives? What resources do I have/need to achieve the above? How will I organise my group? How will I demonstrate our value/show we are successful? 4

5 Typical activities and responsibilities Product and Project work Department structure People management and performance appraisal Training/development Resource planning Recruitment Budget Networking Inspection readiness Compliance Company policies and SOPs 5

6 Department Structure Experience Capabilities Development opportunities Secondments Solid/dotted line reporting People Therapeutic Geographical Business Alignment Nature of Company Consider HQ /Affiliate Generic CRO Start-up Customers Size of Department Sales and marketing Manufacturing R and D Regulatory Authorities 6 Functional groups CMC Nonclinical Labelling / Post- Marketing support Early development International Support functions Operations Reg. Intelligence Therapeutic groups

7 Department Structure Identify priorities, essential vs. nice to have, e.g. core groups / support groups, what can be shared, what is done by HQ/CROs etc Benchmark other companies, obtain feedback from within - what does/doesn t work Implement hierarchy according to dept need, staff experience and skills. Support with coaching/mentoring. Dedicated line managers, or player/managers Outsourcing to CRO vs. inhouse. Less resource but not building in-house expertise. Consider temporary or permanent staff, ad-hoc consultancy. Clearly define roles and responsibilities, expectations. Task specialist or product specialist 7

8 Systems and Processes Structure Document management, Publishing, templates Records and archiving Commitment and safety-related tracking Work planning and reporting Training and compliance Policies, SOPs, Standard Working Practices Regulatory Intelligence 8

9 Resourcing a Project Look at existing priorities, resource and skills Identify project managers vs. technical experts Don t be afraid to move people around Consider stretch assignments, but ensure support is in place don t set people up to fail Consider secondments from HQ/Affiliates Permanent hire vs. consultants Provide incentives and rewards! Complete, review, report, praise, thank Communicate, agree, delegate, motivate, inform, enable Plan, prioritise, check, measure, review, adjust 9

10 Resource Models Develop process flows and resource models for standard tasks How long should an activity typically take? How many tasks can an individual manage? Keep an overview of what staff are working on, and deadlines Enables you to effectively balance workload, compare performance (and reward, praise) 10

11 Time Management Set time aside for tasks no ! Be realistic about how long things take Prepare for meetings Follow up on actions Be available for your staff 11

12 Performance Management 12

13 Performance Management Read, understand and follow company procedures Beginning of the year: Set SMART objectives, according to business needs Agree a personal development plan based on gaps in knowledge and/or skills Identify suitable training courses (internal and/or external) Consider coaching/mentoring e.g. for high potential staff taking on more responsibility Mid-year Review progress against objectives, if not on track why not? If different priorities, revise objectives If difficulties, discuss and put closer monitoring in place End of year Obtain feedback on performance against objectives and core role competencies Important to encourage honesty (like, dislike and do differently) Be consistent and transparent when ranking 13

14 Measurement of Performance Achievement of goals/objectives Quantify work output Quality of work Issue management Key Performance Indicators what do your stakeholders value? 360 feedback Demonstrate quality, improvement 14

15 Managing poor performance Verify: Obtain full and adequate feedback 360 ⁰ review Identify Cause: Lack of support, under-resourced; or Competency issue Solve: Support with coaching/mentoring/change reporting Monitor closely, set short term objectives Hold regular prioritisation meetings; review projects as a group; share learnings Work with HR; put warnings in place and follow strictly the process through to outcome Out-source work, bring in consultant 15

16 Interviewing Job Description Job specification: title and summary of role, position in company, reporting structure, duties Personal specification: knowledge, skills, essential vs. desirable Understand your role as interviewer What do you need to know from the candidate vs. what other interviewers will cover, avoid repetition work with HR Ask open ended questions based on key role competencies Allow candidates time to think and speak, but keep control Consider the person not just the CV What type of personal qualities are needed for the job What mix of personalities do you already have in the department aim for balance Don t be afraid to hire new graduates for junior positions 16

17 Budget Accurate forecasting critical but challenging. Many companies want within +/- 3-5%. Review frequently with finance. May be linked to your performance objectives and therefore your pay rise/bonus! Important for planning, deciding between competing priorities, making informed decisions, knowing when plans are going adrift, communicating financial decisions to senior mgt, benchmarking.. Consider carefully: salaries, travel, anticipated filings, scientific advice, training, external consultancy, IT, etc... Identify what will be spent, not what should be spent 17

18 Team Meetings Agenda driven Regular schedule, rotating chair? Information sharing, to agree common position Focus topics invite other departments to learn from and educate Issues/hot topics Celebrate achievements, acknowledge success Capture actions and distribute according to resource, capability, development opportunity etc. Decisions should be documented 18

19 Cross-Functional Strategy Meetings Define Regulatory responsibilities Provide strategic input Work collaboratively Liaison with Agency Anticipate Qs and prepare Q&A Relevant Guidelines Knowledge of Agencies Precedents SWOT analyses Business label devt. Clinical proposed studies Safety labelling, risk management All: define questions 19

20 Inspection and Audit GCP, Pharmacovigilance, GMP, Internal Audit Product specific, routine systems, for cause Identify core procedures for regulatory affairs and ensure you have up to date SOPs and SWPs and that your department is working to these procedures (compliance) Prepare SOPs/SWPs for any critical processes that currently do not have appropriate procedures in place - before the inspection! Ensure that any follow up measures from the previous inspection are fully completed or that an action plan is in place and on track Corrective and Preventative Actions (CAPAs) 20

21 Inspection Preparation Select potential interviewees CV, job description, training record Conduct mockinterviews Interviews Look on agency website MHRA good example. Consider if country legislation applicable as well as EU (e.g. UK SIs). Consider consultant for advice Preinspection dossier Identify Project Manager Understand the process List of CTAs, MAs Organograms SOPs Key contacts Facilities Key service providers SOPs / WIs Identify key SOPs e.g. tracking submissions, approvals, commitments Handling of AEs/SAEs Interactions with CROs contracts and agreements, document management Supply chain release, recall 21

22 What does a successful RA manager look like? Communicates well across all levels of the organisation Motivates, challenges, develops and supports their team to achieve their goals Gains the respect and confidence of other departments and external customers Offers well constructed strategic advice and brings creative solutions to problems Keeps calm under pressure and keeps others on track 22

23 In this presentation we covered Building the Regulatory Affairs department structure Managing resources, including time, staff and budget Preparation for meetings, audits, inspections Measurement of performance of the RA department 23

24 QUESTIONS? 24

25 Acknowledgements Stella Andrews (Roche) Contact details Name: Liz Gifford Tel: