CRED Project Management for Regulatory Affairs Professionals
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Project Management for Regulatory Affairs
Professionals 5 March 2019
*Course presentations
* ©The Organisation for Professionals in Regulatory Affairs 2018 Presentations are supplied to delegates for their personal reference and are the copyright of the speaker and The Organisation for Professionals in Regulatory Affairs. The presentations must not be copied, stored in a retrieval system or transmitted in any form without prior permission from TOPRA. Agreement must be reached with TOPRA before any part of this material is reproduced, abstracted, stored in a retrieval system or transmitted in any form by any means – that is, electronic, mechanical, photocopying, recording or otherwise.
CRED Project Management for Regulatory Affairs Professionals 5-6 March 2019 Presenters: • Dipesh Mistry, Pfizer Ltd • Gurdeep Bhangra , IQVIA Limited • Joe Cheal, Imaginarium Learning & Development • Sinéad Usher, Smart Regulatory Services Ltd Day 1 Programme Time Presentation 09.15 Registration and coffee 09.30 Welcome from TOPRA 09.40 Introduction • Welcome & domestics • Introduction to the speakers • Course overview/objectives • Your aims/objectives? • Your introduction (including personal aims) 10.10 What is Project Management • What is a project? • Life cycle: The four-stage project o Define (what/why), Plan (how), Implement, Final Review o The Fantasy – Reality Gap • The Time Cost Quality Triangle… plus the missing piece! • Qualities of effective project managers 11.10 Tea/ Coffee break 11.30 Project Management and how it fits with Regulatory Affairs • Definitions of Regulatory Affairs and Project Management • What are regulatory projects? o Roles of RA pre and post Marketing Authorisation Approval o Other RA projects • Regulatory Affairs (RA) professionals as Project Managers 12.15 Stage 1: Defining • What is the defining stage? • The Pre- Project ‘P’s • Identifying stakeholders o Governance (Internal and External) • Project kick-off meeting o Scope • Risk o Contingency planning 12.45 Lunch 13.30 Stage 1: Defining (Cont.) 14.30 Tea/ Coffee break 14.50 Stage 2: Planning • Work Breakdown Structure
Time
Presentation
o Roles & responsibilities o Creating and reading charts o Milestones Communication & reporting Plans Gantt/Timeline Charts
•
•
16.20 16.40
Review of the day
Close
Day Two Programme
Time 09.10 09.30
Presentation Introduction
Stage 3: Implementation •
Project delivery: Staying on track and within budget (time-cost- quality) • Handling change and handovers • Key skills: o Juggling projects and everyday work o Delegation o Chairing project review meetings & how to maintain control o Dealing with ‘difficult’ people (with different priorities) o Maintaining motivation
Tea/ Coffee break
10.40 11.00 12.00
Stage 3: Implementation Cont’d
Stage 4: Final Review •
Why review the project (and why does it not always happen)? • Making the reviews useful • Key questions to ask, e.g.: o What to do differently next time? o What to do now – follow up? o How to celebrate? • Recording & sharing information/ lessons learnt
Lunch
12.30 13.15
Case Study: A Regulatory Project Tea/ coffee to be taken during case study
15.00 16.15 16.45
Case Study Feedback Review and discussion
Close of Meeting
CRED Project Management for Regulatory Affairs Professionals
Speaker biographies
Dipesh Mistry Dipesh Mistry started his regulatory journey after a brief encounter in Pharmacokinetics and has worked in departments such as CMC, Submission Management, Project Management and more recently working in the Oncology space within Pfizer’s Established Health business. He has worked in a variety of organisations including big pharma, generics, CROs and consultancies. Dipesh is a big supporter of education of science, and volunteers as a STEM ambassador for London and the South East of England. Gurdeep Bhangra Gurdeep has more than 15 years’ experience in global Regulatory Affairs. She began her career in the Pharma Industry supporting Marketing Applications and move into the CRO field as Regulatory Project Manager. Responsibilities include provision of strategic regulatory support to plan, build an delivery high quality regulatory clinical trial applications globally to support product development plans for the pharma industry. Joe Cheal Joe Cheal, from Imaginarium Learning and Development, has been training, consulting and coaching since 1993, working with thousands of people from a diverse range of companies over the past 25 years. He is a highly interactive and engaging speaker who focusses on practical solutions for ‘real-world’ implementation.” Sinéad Usher Sinéad Usher has almost 20 years of regulatory experience. She is currently the director of SMART Regulatory Services Limited which provides regulatory expertise to both large Pharma and CRO’s. Assignments have included Regulatory Project Manager roles with responsibility for a range of portfolios such as vaccines (biological), oncology, respiratory and more recently HIV. Other regulatory assignments have included: Labelling Audit Project, Regulatory Intelligence, Common Technical Document conversions and auditing dossiers for submission. Sinéad is a registered pharmacist and has a post graduate diploma in regulatory affairs with distinction.
CRED Project Management for Regulatory Affairs Professionals
Project Management and how it fits with Regulatory Affairs
5-6 March 2019
Sinéad Usher, Director, SMART Regulatory Services Limited
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
Learning objectives
• Definitions of Regulatory Affairs and Project Management • What are Regulatory Projects? ● Rôles of RA pre and post Marketing Authorisation approval ● Other RA projects • Regulatory Affairs (RA) professionals as Project Managers
DEFINITION of a Regulatory Affairs Professional
A regulatory profess ional is responsible for keeping track of the ever- changing legislation in all the regions in which a company wishes to distribute its prod ucts, advise on the legal and scientific restraints and requirements, and collect, collate and evaluate scientific data. They are responsible for the presentation of registration documents to regulatory agencies, and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the products concerned. They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.” https://www.topra.org/TOPRA_Member/About_Us/What_is_regulatory_affairs_/TOPRA/TOPRA_Member/What_is_regulatory_affairs.aspx?h key=d6c99cd1-dcb4-4e9f-9a6a-2fed902b2b00
TOPRA webpage, downloaded 16 June 2018
DEFINITION of a Regulatory Affairs Professional
A regulatory professional is responsible for keeping track of the ever-changing legislation in all the regions in which a company wishes to distribute its products, advise on the legal and scientific restraints and requirements , and collect, collate and evaluate scientific data . They are responsible for the presentation of registration documents to regulatory agencies , and carry out all the subsequent negotiations necessary to obtain and maintain marketing authorisation for the products concerned. They give strategic and technical advice at the highest level in their companies, right from the beginning of the development of a product, making an important contribution both commercially and scientifically to the success of a development programme and the company as a whole.” https://www.topra.org/TOPRA_Member/About_Us/What_is_regulatory_affairs_/TOPRA/TOPRA_Member/What_is_regulatory_affairs.aspx?h key=d6c99cd1-dcb4-4e9f-9a6a-2fed902b2b00
TOPRA webpage, downloaded 16 June 2018
DEFINITION of Project Management, what is a project?
It's a temporary endeavor undertaken to create a unique product, service or result. And a project is unique in that it is not a routine operation, but a specific set of operations designed to accomplish a singular goal. Project management, then, is the application of knowledge, skills, tools, and techniques to project activities to meet the project requirements.”
https://www.pmi.org/about/learn-about-pmi/what-is-project-management Project Management Institute, downloaded 16 June 2018
DEFINITION of Project Management, what is a project?
It's a temporary endeavor undertaken to create a unique product, service or result. And a project is unique in that it is not a routine operation , but a specific set of operations designed to accomplish a singular goal. Project management, then, is the application of knowledge, skills, tools, and techniques to project activities to meet the project requirements.”
https://www.pmi.org/about/learn-about-pmi/what-is-project-management Project Management Institute, downloaded 16 June 2018
RA and Lifecycle of a medicinal product
RA involvement
Pre-MA Approval
Time
MAA Approval
Start of Clinical Trials
Divestment or Cancellation
Market expansion
MA submission
MAA= Marketing Authorisation Application
Pre-Marketing Authorisation approval
• High profile, high resource • Is there a dedicated Professional Project Manager?
Waterfall
Waterfall
Black belt
PRINCE2
RA and Lifecycle of a medicinal product
RA involvement
Pre-MA Approval
Time
MAA Approval
Start of Clinical Trials
Divestment or Cancellation
Market expansion
MA submission
MAA= Marketing Authorisation Application
RA and Lifecycle of a medicinal product
RA involvement
Post-MA approval
Pre-MA Approval
Time
MAA Approval
Start of Clinical Trials
Divestment or Cancellation
Market expansion
MAA submission
Post-Marketing Authorisation approval
• Market expansion • Lifecycle management e.g. variations for specification change or label extension • Majority of regulatory professionals work in post-MAA • Less money resource • Less likely to have a dedicated R&D project manager • Therefore, more likely that Regulatory function takes a lead in project management
RA and Lifecycle of a medicinal product
RA involvement
Advocacy, Regulatory Intelligence and other projects
Post-MA Approval
Pre-MA Approval
Product Incident and process gaps
Time
MAA Approval
Start of Clinical Trials
Divestment or Cancellation
Market expansion
MAA submission
Regulatory Affairs professionals as Project Managers
Regulatory Affairs professionals as Project Managers
Competent Authority e.g. EMA
Supply Chain
Safety (PVG)
CMC
Clinical
Regulatory
Non- Clinical
Marketing
Project Managem ent
Labelling
Publishing
Regulatory Affairs professionals as Project Managers
Patient/ HCP
Competent Authority e.g. EMA
Supply Chain
Safety (PVG)
CMC
Clinical
Regulatory
Non- Clinical
Marketing
Project Managem ent
Labelling
Publishing
Regulatory Affairs professionals as Project Managers
Patient/ HCP
Competent Authority e.g. EMA
Supply Chain
Safety (PVG)
CMC
Clinical
External
Regulatory
Non- Clinical
Marketing
Project Managem ent
Labelling
Publishing
Your Objective…
• Think of a regulatory project • The project can be past or present that you have personally worked on • Take 5 minutes to think about your project at the end of each of the 4 stages: • Defining • Planning • Implementation • Review • What will you do? Or what would you do different?
Learning Outcomes Recap
Definitions of Regulatory Affairs and Project Management ● RA profession is diverse and likewise projects are diverse and unique What are Regulatory Projects? ● Rôles of RA pre and post MAA – often differs, but principles overlap ● Other RA projects- never to be overlooked Why are Regulatory Affairs professional chosen as Project Managers? ● Key link to many functions
Abbreviations
CPP – Certificate of Pharmaceutical Product HCP – Healthcare Professional MA – Marketing Authorisation MAA – Marketing Authorisation Application PIP - Paediatric Investigation Plan (EU terminology) PM – Project Management PSP - Pediatric Study Plan (US terminology)
PV – Pharmacovigilance RA - Regulatory Affairs R&D – Research and Development
Thank you for your time. Questions?
CRED Project Management for Regulatory Affairs Professionals
STAGE 3. IMPLEMENTATION Practical Examples
2-3 August 2018
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
Dashboard?
What is a Dashboard?
A Dashboard is a visual to show KPIs They can be used during regulatory team meetings to show:
– Key submission milestones – Submission, Approval dates – Planned vs Actuals – Align your strategies and goals – Metrics
Regulatory Response
Safety Response
Efficacy Response Clinical Lead/Pharm Sci
Responsible Person
GRL
SRL
Final Draft
DD-MMM-YY DD-MMM-YY DD-MMM-YY
Document Status
Or as complex as this…
Image Reference: https://docs.losant.com/dashboards/overview/
Global Working
Benefit of Global Working
Access to regulatory knowledge for that market Interfacing with regulatory authorities in nature
language 24 hours
Networking Cost Saving
Best Practices
Be mindful of language barriers Time zone differences – consult your stakeholders Public Holidays – how will this impact you project? Meeting Minutes – keep them simple Cultural differences (do not get offended)
CRED Project Management for Regulatory Affairs Professionals
Stage 4: Final Review
5-6 March 2019
Gurdeep Bhangra, Regulatory Affairs Manager, IQVIA Limited
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
Learning Outcomes
Stage 4: Final Review Why review the project (and why does it not always happen)?
Making the reviews useful Key questions to ask, e.g.: ● What to do differently next time?
● What to do now – follow up? ● How to celebrate the successes ● Constructive Feedback Recording & sharing information/ lessons learnt
Operational Challenges.. And Solutions..
Why review the project (and why does it not always happen)? Making the reviews useful Key questions to ask, e.g.: What to do differently next time? What to do now – follow up? How to celebrate? Recording & sharing information/ continual assessment Internal &/or External risk factors
Operational Challenges.. And Solutions..
• Why review the project (and why does it not always happen)? • Typically projects are driven by timelines and financial targets. During the intensive periods of the project deliverables, it is not always possible to “take a pause” and review, what is working and where areas can be improved. • Sometimes a “sticking plaster” approach is taken as issues are arising.. rather than a holistic one to meet the timelines and objectives of the project • Making the reviews useful/ Key questions to ask, e.g.: • Don’t be afraid – if you are unclear of your role/responsibilities vs. the project scope, it is possible that other team members may need clarity, but are not sure who to ask. • Remember – There are no “stupid questions”
Operational Challenges.. And Solutions..
What to do differently next time? ● Review, Assess, discuss and revise ● Change for the sake of change does not always fly… ● Propose suggestions that management can relate to – Impact on costs reduction, reaching goals in a timely manner will engage with key stakeholders to Follow up ● Feedback to key stakeholders. ● Positive constructive feedback is always a win-win. – For e.g. ” Team A didn’t deliver and messed up the timelines ” may lead to resistance from teams and management.. – Whereas changing the tone to “ Though Team A delivered output was delayed, it was of high quality and no rework was required. Inevitably, this did impact Team B and C deliverables and the final project output-timelines. In the future allowing for additional reviews and management oversight may be worth considering to ensure timely and seamless output …”
Operational Challenges.. And Solutions.
How to celebrate: ● Objectives Achieved – ● On time and within budget ● Feedback and encouragement to teams from Project team and Senior Management ● Positive team work Recording & sharing information/ continual assessment ● Purpose of the exercise is not to blame anyone or team, but to learn and strive to continually improve. Internal &/or External risk factors ● Matters outside of our control – change of regulations, requirements, company SOPs/Processes..
Transferring the Knowledge – Real life example
Project Review [PROCESS]: Regulatory Strategy and Delivery on a Phase III Global Clinical Development for Alzheimer's Disease Programme. [Study included use of tracers] Challenges – What did not go well [Development] ● Clinical Trial Applications – Received More than 50% Validation Queries ● Every Clinical Trial Application received Regulatory Questions: – Questions on IMPD, Protocol Design, Application Forms. ● Resulted in more than 50% Country-Specific Protocol Amendment’ – Impact: Study Result Analysis, as this was intended to be the pivotal study for Marketing Authorisation Application.
Global Study Impact vs. Marketing Authorisation/Registration Goals
• Clinical Programme Start-Up timelines significantly increased • Clinical Research Investigators time is of essence. Delays with obtaining Regulatory and Ethics approvals impacts their availability to recruit patients and support the study. • Outreach to Sites and Patients delays • Patients miss the opportunity to take part in ground-breaking research • Perception of Sponsor (and CRO) at ECs/RAs • Pharmaceutical Companies – Retain a positive, responsible perception with the authorities [Broader Aspects – Impact on future projects]
Why (?) – Operational Planning
Learning Points/Future recommendations Sponsor [Pharmaceutical Company] – Typically seeks Scientific Advice from US FDA and EMA for Protocol Design and CMC (Quality) and Pre-Clinical product Development strategy. ● If Sponsor decision is to not include all of the SA recommendations – Justifications for deviation from guidance obtained/protocol study design should be carefully considered. [People] Country Specific Regulations & Guidelines ● Knowledge and Application of Regulatory requirements at Local Office/Affiliate level [People] Adhering to Requests from Local Affiliates ● Sponsor accommodating requests to support accurate clinical trial applications – some resistance [Denmark PGx], affected delays [People] Communication
Meeting the Project Objective –
Outcome –
Study was started up – Delays of 6-12 months Patient recruitment slow – Interim analysis - indicated no additional benefit from the study drug Start Up/Regulatory Delays – Significant impact on budgets
CRED Project Management for Regulatory Affairs Professionals
Article 30(1) Case Study Introduction
6 March 2019
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
Purpose of Article 30(1) of Directive 2001/83/EC
Article 30
MRP
Harmonisation of dossier strategy
Indication(s)
ADRs
Quality
Clinical Study Report(s)
Safety Databases/PSURs/RMP/ Literature Searches
Module 3 Drug Product
SmPC and PIL
Clinical Overview/Tabulated Summaries
Clinical Overview/Tabulated Summaries
SmPC and PIL
SmPC and PIL
CRED Project Management for Regulatory Affairs Professionals
Article 30(1) Case Study Introduction
6 March 2019
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
Purpose of Article 30(1) of Directive 2001/83/EC
Article 30(1)
MRP
Harmonisation of dossier strategy
Indication(s)
ADRs
Quality
Clinical Study Report(s)
Safety Databases/PSURs/RMP/ Literature Searches
Module 3 Drug Product
SmPC and PIL
Clinical Overview/Tabulated Summaries
Clinical Overview/Tabulated Summaries
SmPC and PIL
SmPC and PIL
CRED Project Management for Regulatory Affairs Professionals
Article 30(1) Case Study Example Answer
6 March 2019
ENABLING AND PROMOTING EXCELLENCE IN THE HEALTHCARE REGULATORY PROFESSION
Stage 1: Define the Project
Project P’s Problem
Divergencies in the registered indications and shelf-life across several EU markets. TOPREXA – aiming for identical indications, ADRs and shelf- life across the 12 Member States (MS) Safety and confidence in the product through harmonised labelling. Increase in shelf life, patient exposure
Product/service/outcome
Purpose
Process
Comparison of SmPC/Module 2.3 and 3 Current tenders and pricing Available stability data
People
Refer to Stakeholder Slide
Politics
Company position, Commercial, Local requirements, Tenders, Pricing CHMP, National Competent Authorities, Company Senior Management Resource (people and subsequent submissions), Impact on other markets (labelling dependencies)
Power
Pounds
Priorities
Supply to patients, Timelines, Label
Stage 1: Define the Project
Scope • Harmonise SmPC indications, ADRs and shelf-life for 12 MSs.
Scope Creep (Avoid) • Other EU national authorised products for TOPREXA • Impact to labelling where EU National SmPC is a reference label for Emerging Markets. • Pricing and reimbursement nationally.
Stakeholders – Roles and Engagement
Clinical
Senior Mgmt
Commercial
Regulatory Operations
Medical Writing
Regulatory Affairs
Labelling / Artworks
Pharmaco- vigilance
– ‘Spanner’ Holders – Team Members – Service Providers – End Users
Pharma-Sci
CMC
Stakeholders
Spanner Holder
Team Members
Service Providers
End User
CHMP
CMC
IT
Patient
TOPRAPharm Pharmcoviligan -ce
Information Management (IM) Document Management System
Research and Institutions
Patient Advocacy Groups
Regulatory
Healthcare Professionals
Labelling Manufacturing Site(s)
Pharmaceutical Sciences
Artworks
Medical Writing Publishing Clinical
Identify Risk and Contingency Planning
Missing submission Date
Delays of issuing CPPs
Labelling worst case scenario
Loss of market share
Team members leaving
Risks
Different Timezones /Language barriers
Poor Handovers
Annual Leave/ Public Holidays
Validation Issues
Work Breakdown Structure
Medical Writing Provide Support CSRs
Clinical Sub Team Meeting
Senior Mgmt Approval
Author CO Addendum
Safety Conducts SB and Literature Search
Author Safety Report to support ADRs
Safety Sub Team Meeting
Update EU Nat Labels
Senior Mgmt Approval
Update EN Labels
KO Meeting to discuss CHMP Q’s
Publishing
CMC Assess Current Available Stability Data
Update Relevant M3 Sections
Author Cover Letter
Author Response Document to CHMP Questions
Example GANTT Chart
Task No. Activity
Duration (Days)
DPB
1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22 23 24 25 26 27 28 29 30 31 32 33 34
1 KO Meeting
1 1 2
2 Clinical Sub Team Meeting 3 Medical Writing Provide CSRs 4 Author CO Addendum 6 Safety Sub Team Meeting 7 SB and Literature Search 8 Author Safety Report 9 Senior Management Approval 10 CMC Assess Current Data 11 Update Relevant M3 Sections
1 3 4 1 6 8
10
1 5
10
2 1 5
4,8
1
10
12 Author Response Document to CHMP Questions
12 3,7,11
13 Update EN Labels 14 Update EU Nat Labels 15 Author Cover Letter
2 5 5
9,12
13 12
16 Publishing
20 4,8,12,13,14,15
Communication Plan
Executive Summary
Frequency of distribution
Lessons Learnt
Key Messages
Content
Schedule
Roles and Responsibilit -ies
Target Audience
Communicat ion Media
Stage 3: Implementation
1.What can change and how do you handle it?
2.How do you maintain motivation?
Stage 4: Final Review
Reviewing and Closing out activities: • How does your company perform reviews? • How do you or would you record and share the knowledge gained?
Acknowledgements here if required (16pt)
Onsecuptatur? Ximus, cumquam eatae volorror sequatus ata quis elis accae. Nequia seritia sum sequam es as estorum quodis con cuptate niendae. Nam, consequid expeliciae. (14pt)
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