CRED Successful and Skilful Communications 2025
CRED Successful and Skilful Communication 2025
©The Organisation for Professionals in Regulatory Affairs 2025 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: Successful and Skilful Communication 21 January 2025
Programme
Presenters: Joe Cheal, Imaginarium Learning & Development
Time
Session
9:15 9:25 9:30
Registration Welcome from TOPRA
Introduction & Context Setting • Definitions: Negotiation and Influence • The Four Qualities of Influential People
The Principles of Negotiation •
Results, approaches and strategies
Stages of a negotiation
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• Tradeable and Concessions: making a negotiation more effective
10:45
Morning Break
11:00
Negotiation Planning & Doing •
Getting Clear about your outcome
• Key questions: What do you need to know? • How to avoid surprises • Golden rules and general do’s and don’ts
Presentation Planning and Structure • Planning tool – structuring and sequencing • Developing an impactful introduction • Working with the ‘mind of the audience’ – how to engage!
12:30
Lunch
13:15
Presenting Your Proposal •
Presenting complex information
• Handling questions: ‘On the Spot’ Model
14:45
Afternoon Break
15:00
Presentations with Feedback
16:30
Wrap-up
17:00
Close
Programme subject to changes
Speaker biography
Face-to-face course presenter: 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.”
Webinar presenter: Andy Thornley
Andy was a broad-based Regulatory Affairs leader during his many years in Industry (companies included GSK and J&J) with a background for the most part in Consumer Health Regulatory Affairs, and information systems. He has been an active and enthusiastic member of multi-disciplinary process excellence, innovation and brand management teams within these companies. This enthusiasm has been carried over while representing the AESGP (self-care) industry trade association at Industry-European Medicines Agency (EMA) - EU National Competent Authority (HMA) forums for ISO IDMP/ SPOR, e-Product Information, eCTD V 4.0, EU Telematics, EU Clinical Trials Database and Portal (CTIS), and Regulatory Optimisation (ROG). As a regular presenter/ day-chairperson for over 16 years training on behalf of TOPRA, Andy has covered both technical (EU Pharmaceuticals) and soft skills. In the webinar, Andy will draw on both areas, to present important considerations regarding communication and influencing, which should help you with your development as an effective Regulatory Affairs professional.
2022
Principles of Effective Regulatory Communication
Andy Thornley, EU Regulatory Policy & Intelligence, UCB Pharma
Creating a Win/Win for Regulatory Affairs and your organisation
Webinar 1 of TOPRA Successful and Skilful Communications Series
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Learning objectives 1. Fundamentals of internal and external negotiation 2. When, why and how to interact with regulators 3. How to prepare for best outcomes from an interaction 4. Lastly we’ll use the advisory meeting with regulators as a practical example. ● the principles for holding a successful advisory meeting ● how to follow up Please note that the views and opinions expressed in the following presentation are those of the presenter and are not a representation of the opinions of his employers
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1. Fundamentals of Internal and External Negotiation
Principles, conditions, steps
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The principles of negotiation
1. Stages of a negotiation 2. Tradeables and concessions: making a negotiation more likely to be a win-win
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Stages of negotiation
Discuss Prepare
Test
Trade
Agree
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The WEB and the WAP
The WEB stands for: Worst – Expect - Best What is the worst deal you would accept? This is also known as your WAP (Walk Away Position), because you would rather
walk away from the deal than go any lower? What sort of deal do you realistically expect?
This will be somewhere between the worst and the best. It will usually be based on any experience/ history you are aware of Consider what might be the WEB and WAP of the other party
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Tradeables
Tradeables are also known as concessions or sweeteners. They are the added extras that a party can offer to help oil the wheels of a negotiation. The best kind of negotiation is where you are trading things that are low cost to you but valuable to the other party, and they are trading things that are low cost to them but valuable to you. Both parties gain, leading to a win-win. Tradeables are not the same as features or benefits. A tradeable can be added or not added to a deal, whereas standard features and benefits exist anyway. The test is whether you could remove it effectively from a deal or not
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The basis for successful negotiations is trust
If there is trust
• negotiations run smoothly • fewer controls are necessary
If there is no trust • there is an immediate challenge in winning trust and gaining attention • the outcome is more likely to be unsatisfactory for one or more parties
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Pause for thought What questions come to mind so far?
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2. When and Why to Interact with Regulators
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Regulators
• Are your key external gate-keepers • But the principles of this training can equally apply to dealing successfully with other external and internal stakeholders and customers
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With Regulatory Authorities: ● Advice on the Clinical Development Programme ● Eligibility for special designation such as PRIME or Orphan Drug ● Pack labelling/ SmPC wording (e.g. posology details) ● Shelf life ● Product name (applying umbrella branding) With colleagues: Negotiations in regulatory situations
● Submission timelines ● Data to be generated
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Why interactions with your regulators?
Build and maintain relationship with your ‘key customer’ • Establish trust – be truthful and objective • Establish early dialogue if possible • not too early, plan first • do not wait until there are issues or the issues worsen • Anticipate issues and jointly resolve problems, before they become serious • Share the logic of regulatory strategy and if relevant, development plan • Communicate new data • Monitor changes in regulator’s attitude or expectations of data
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General scientific advice can be obtained for …
• Questions relating to the interpretation and implementation of (draft) guidelines, (draft) pharmacopoeial monographs • Emerging and new therapies • Evidence to support a product claim • Product classification (e.g. device vs medicine) • On methodological questions, e.g. release testing, bioquivalence
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• The European Medicines Agency • The Biocidal Products Committee/ European Chemicals Agency • National Competent Authorities (AIFA, BfArM, DIKLZ, FAMHP, HPRA, MHRA, AEMPS) • Notified Bodies (BSI, LRQA, NSAI, SGS Belgium, TÜV NORD) • Trade Associations: ● Biocides: EFTA, ● Cosmetics: Cosmetics Europe, CTPA ● Medicines: EFPIA, Medicines for Europe, Europabio ● Medical Devices, ABHI, BIVDA, BVMed, EMIG, Eucomed, MedTech Europe Who are the external “regulators/ gate-keepers”?
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Product specific scientific advice can be obtained for …
• Environmental risk • Use of ingredients • Advertising copy • Development strategy to optimise drug development • Quality Target Product Profile (QTPP) • Clinical protocol assessment • Extension of indication • PIPs • Post-authorisation / FUM*s / PSURs / line extensions
16 * Follow-up Measures
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For medicines, scientific advice in Europe is … • Prospective in nature • Not legally binding with regard to any future application of the product concerned • Limited to scientific issues - regulatory aspects (e.g. legal basis for submission, GCP/GLP/GMP related questions, format of application) should be the matter of a separate request (pre-submission meeting) • Mentioned in the EPAR • Possibly joint advice between • CHMP and FDA (in parallel) • HTA agencies and CHMP / or national regulators • Possible, if recommendations from the US and EU differ significantly
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• Companies ● e.g. Scientific Advice, follow-up advice, labelling, promotional material, procedural questions • National authorities or EU Committees ● e.g., oral explanations, safety referrals in PRAC-CHMP ● Note: procedural questions normally free, as would be when regulators summon hearings with companies. Normally when a company requires scientific advice a fee is involved Both sides can request interactions – formal and informal
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Role of the RA professional
The regulatory affairs professional is • Primary representative of organisation in regard to the communication with the other party • Representative and signatory as the organisation’s “responsible official” • Person usually responsible for educating and advising others in the organisation about regulatory procedures and requirements
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Key principles for interactions
• Pre-plan interactions to increase efficiency and clarity of requests or issues • Document interactions with regulators to ensure appropriate follow-up • Advice from regulators/ gate-keepers is only as good as the background information provided and questions posed
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• Correspondence / letters • Phone calls • Secure e-mail • Meetings − Teleconferences − Face to face − Videoconferences (rather uncommon) The following interactions are possible
Recommendation: have an SOP for interactions with regulators/ gate-keepers
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Email • Arguably the most commonly used channel of communication • All the rules about negotiation apply • Prepare ● What are the WEB, WAP and Tradeables? ● First discuss with team or line-manager and confirm that messages are clear and unambiguous • Not always as powerful a negotiating medium as meetings etc
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Phone calls to regulators/ gate-keepers
• Good for procedural advice and explanation • Works well for gaining a sense of external position before committing to formal written dialogue • Calls are typically between organisation’s RA professional and regulator’s project manager or administrator • Be efficient – evaluate necessity for call – ensure proper planning for call – if possible, call when there are multiple topics to cover • Follow up on any action items in timely manner • Document interaction and share information from call
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Phone calls, emails and letters from regulators
RA professionals should ● Speedily and efficiently generate minutes of conversations and distribute these and other significant information from regulator (e.g. letters, emails) to appropriate individuals within organisation ● maintain files with original correspondence and minutes of conversations
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Considerations • organisation’s internal expertise, opinion leaders, regulatory consultants, advisory boards • Regulators’ expertise • Experience with other products: minutes from scientific advices, lists of questions, recent approvals, refusals • Existing (e.g. recently approved) EPARs for similar products • Status of development • Geographical aspects • Existing EU, ICH (draft) guidelines • Risk of being told “something you don’t want to hear”! Do you need to meet regulators face-to face?
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3. How to Prepare for Best Outcomes From an Interaction
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When requesting an interaction, you need to consider
Specific know-how may be required from regulators ● Ensure availability of expertise at chosen authority ● Carefully select discussion topics Timing ● Meaningful data/ concepts for discussion are prerequisite for significant regulator feedback ● Dispatch of request for interaction by RA depends on availability of mature questions and outline of organisation position ● ‘Backward’ timeline planning
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Preparation of your discussion topics
• Questions must be ● Well-structured and precise
● Not open – regulators expect data-driven organisation position ● Strategic, having short- and long-term implications in mind • Answers are supposed to minimise the risk that development programme or parts of it do not meet expectation of your regulators • Anticipate and prepare for questions from your regulators – don’t fear them - evaluate them in advance • Work out organisation fall-back positions (WEB and Tradeables) and cross-check with peers/ team/ line manager on wording of questions • Make sure applicable guidelines are well understood, and that any deviations from existing guidelines are necessary
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Questions should be framed around organisation’s viewpoint and justification for this should be presented For example ● The company feels the following clinical trial endpoint is more appropriate because …. Does the authority agree with acceptability of this endpoint as proof of efficacy? ● Does panel agree that current clinical program will support registration of the desired indication in Europe Don’t ask open ended questions – be clear with questions Examples for questions
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Remember
Good communication is something that can be understood
Great communication is something that cannot be misunderstood
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Pause for thought Any questions
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4.The Principles for Holding a Successful Meeting and How to Follow Up
Using the Scientific Advice Meeting with the EMA or a National Competent Authority as the grand example to showcase general principles
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Prior to the meeting
• Set reasonable expectations internally – for organisation team and management • Agree on fall-backs or alternatives (particularly with marketing team) • Send briefing ahead of time outlining key discussion topics • Recruit BEST personnel to be present in meeting - people who know the data and issues • Have key points and questions easily accessible to organisation participants
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Preparation for an advisory meeting
• Don’t schedule meeting until enough data are available to discuss • If formal, follow regulator’s guidance in requesting meeting and in preparing the briefing • Request identification of regulators’ participants prior to meeting • Obtain information on background of regulators • Advise regulators’ project manager/administrator of any changes in organisation delegation
• Observe ‘visitor’s guidance’ at authority • Send or bring requested desk copies
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Whom do you take with you
Delegation must be chosen wisely and well prepared ● Only people that actually contribute to meeting ● Clear and concise communicators who know when to stop talking and listen ● External experts (academia, health professionals, patients) – pros and cons to be considered Role of each member must be clearly defined ● Delegation Team Lead (RA) and moderator
● Presenter(s) ● Discussants ● Note taker ● Time keeper
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Whom not to take
• Legal representatives • Marketing people
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Remember the 5 “Ps”
P P P P P
erfect reparation revents oor erformance
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And the most important preparation
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More on your rehearsals
• Write out scripts to make sure all are crystal clear and simple – and colleagues can take over in case of emergency • Align external experts and tell them the limits of what to discuss • Focus on items of disagreement and prepare counter proposals, if written comments from regulators have been received before meeting • Don’t forget the non-verbal message - your data maybe perfect, but your voice or your body language may tell it differently • Train your presenters to read the body language of your regulators – do they get the message?
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What you should know about meetings
• Not every meeting is the same • F2F meetings usually take 1 hour or less • There may be a TC instead of a meeting, can take only ½ hour or less • Sometimes regulators will facilitate the discussion, sometimes the company • Sometimes translators/ interpreters are involved • Sometimes the company gives a presentation, sometimes not • For EU advice there are usually no presentations, as they take time - consider paper handouts • Meeting rooms may be very small and may not have projecting facilities
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Typical meetings look like this
• Short introduction of meeting participants and their roles • (Presentation of questions/discussion items + background information) • Discussion • Summary of conclusions and agreements to ensure common understanding • Exit procedure • Farewell & thanks to individual reviewers for their time • Appreciation for good and valuable discussion (and written comments, if received)
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What you do in a meeting
• Focus on questions and content in briefing materials ● present specific proposals and seek agreement ● do not present new data or topics ● all questions have been addressed before you leave • Foster expert-to-expert interaction • If not agreeing ● give examples of why you don’t agree – and do it respectfully ● keep a door open for a fallback position ● ask for or propose a path forward • Watch the time and allow ten minutes at the end to ● Restate your understanding and ask for clarification, if necessary ● Obtain agreement or establish an action plan for all agenda items • Assign one person to do nothing except take notes – RA delegation lead cannot both manage meeting and get everything written down
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What you should NOT do in a meeting
• Fritter away your limited time with a long introductory presentation • Bring surprises or additions to agenda • Fail to clarify comments that are unexpected or that you don’t understand • Ask open-ended questions (e.g. “What do you want us to do?) • Ask questions that cannot be answered at the time, such as questions that are clearly review issues (e.g. “If the primary endpoint just misses significance, can the study still be considered positive?”)
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In a meeting – you had better listen openly
• We have two ears and one mouth, which means: • We should listen twice as much as we speak • Listening is not just waiting your turn to speak
• Regulators usually tell company representatives what they expect
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Meeting etiquette
DOs ● Be polite ● Be prepared ● Bring scientific experts ● Bring data ● Tell the truth ● Be clear ● Be reliable ● Know the players ● Respect the regulator’s point of view ● Control your consultants (KOLs are not always helpful, speak more often about their perception rather than data)
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What you should consider after the meeting
• Advice is given in good faith based on questions and documentation submitted • Advice does not pre-empt outcome of evaluation of a subsequent application • State of the art can change with time ● CHMP will provide argumentation during evaluation of an application when opinion is diverging from its initial position • Feedback from regulator, whilst not binding, represents in writing official regulator’s position at a certain point in time and must be taken seriously
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Important To-Dos after the meeting - Debriefing
• Delegation Team should hold a debriefing meeting with all participants right after the meeting and reach agreement on: • what was said to make sure there is a common
understanding on what has been heard • what to further disseminate at this time
• Fact-based key messages should be sent to internal management body by the delegation team lead directly after debriefing
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Important To Dos after the meeting -Minutes
• Delegation should prepare and agree on final organisation minutes as soon as possible • Minutes should be sent to respective regulator for endorsement or information, as applicable ● Experience shows that comprehensive and truthful company minutes can serve as copy & paste basis for official regulator minutes, and may even serve as vehicle for post-meeting clarifications • Some regulators generally prepare their own minutes ● Their version of meeting minutes should be requested
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When you receive regulator’s minutes …
• Review them to ensure accuracy – They are the official minutes – They give opportunity to clarify meaning of regulator’s advice that is perceived as being not clear, ambiguous or precise enough – In EU procedures - clarifications will be addressed in writing by coordinators if minor, by SAWP if major ● Promptly follow-up on any regulator’s requests from meeting ● Seriously consider recommendations and suggestions – Regulators have seen issues with other products that they can’t discuss with you – Not taking advice into account may expose you to criticism at time of submission/assessment
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If discordance with advice cannot be resolved
• Risk of not following advice needs to be evaluated and documented • Scientific justification needs to be prepared • If you receive an adverse opinion, consider appealing, but only IF you have a strong scientific and regulatory case
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Finally – you should implement the advice
• Implementation Team may be advisable (for major items) • Team needs to follow-up on obtained advice and track its progress • Actions and next steps need to be evaluated, also with respect to impact on budget and overall project timelines To be kept in mind • Advice received from regulators must be included and discussed in an application • “Time pressure” and “budget limitations” are not good arguments
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Key learning outcomes
1. Principles for best way to organise and prepare for your internal or external interaction 2. Feel confident in how to present your case, make your point and use your time efficiently 3. Get prior advice/ feedback on your negotiating approach (*WEB, WAP and Tradeables) 4. Understand the necessity of a fall-back strategy and obtain buy-in from internal partners 5. Know how to select and manage your delegation for achieving the best chance of success 6. Understand the view of the Authority (their WEB)
*Worst – Expect – Best / Walk-away position
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Stages of negotiation
Discuss Prepare
Test
Trade
Agree
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Effective Regulatory Negotiation
Any Questions? Did you get what you wanted today?
Any questions? Did you get the answers that you were seeking?
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Effective Regulatory Negotiation
Andy Thornley, Regulatory Intelligence and Policy, UCB Pharma
Creating a Win/Win for Regulatory Affairs and your organisation
Webinar 2 of the TOPRA Successful and Skilful Communications Series
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Learning objectives
1. Conditions and rules for negotiation A more in-depth look than that of the Communications webinar 2. A look at the regulators/ gatekeepers (largely a recap of the previous webinar) 3. Conflict and how to resolve it 4. Understanding your authority ( when and from whom to seek advice) 5. The importance of clearly understanding the issue from all perspectives. Reading between the lines. Looking for any ‘political’ context. 6. Preparation and rehearsal Scenario mapping (what ifs?)/ fall-back plan.
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The 7 golden rules of negotiation
1. Everything is negotiable 2. Know what you want before negotiating 3. Aim for a Win/Win negotiation (consider what’s of value to them but low cost to you et vice versa ). 4. Understand the principles of negotiation (recap from establishing webinar coming next) – it helps to make it less personal 5. Never believe anyone else is entirely on your side 6. Strive to be innocent (think of TV’s Columbo) 7. Use your communication skills - listen attentively, ask questions and summarise regularly.
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Reminder: The basis for successful negotiations is trust
If there is trust
• negotiations run smoothly • fewer controls are necessary
If there is no trust
• there is an immediate challenge in winning trust and gaining attention • the outcome is more likely to be unsatisfactory for one or more parties
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Approach is shaped by expected/ desired outcome
How important is the relationship with the other party? Will you be dealing with them again in the future (short or long term)? How important is it to get a really good deal for you? How can you encourage a win/win approach and outcome?
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Recap from Webinar 1: Stages of negotiation
Discuss Prepare
Test
Trade
Agree
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Recap: Tradeables (concessions or sweeteners)
Tradeables are the added extras that a party can offer to help oil the wheels of a negotiation The best kind of negotiation is where you are trading things that are low cost to you but valuable to the other party, and they are trading things that are low cost to them but valuable to you. Both parties gain, leading to a win-win Tradeables are optional. The test is whether or not you could remove it from a negotiation agreement
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The WEB and the WAP
The WEB stands for: Worst – Expect - Best What is the worst deal you would accept? This is also known as your WAP (Walk Away Position), because you would rather
walk away from the deal than go any lower? What sort of deal do you realistically expect?
This will be somewhere between the worst and the best. It will usually be based on any experience/ history you are aware of Consider what might be the WEB and WAP of the other party
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Your turn
Let’s take a recent situation in which negotiation with an external authority took place. • What were your WEB and WAP? • Did you have any tradeables? • What do you consider to be the WEB and WAP of the authority with whom you held the discussion?
Or we can consider the WEB, WAP, tradeables in a pending negotiation?
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Regulators
• Are your key external gate-keepers • But the principles of this training can equally apply to dealing successfully with other external and internal stakeholders and customers
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Recap: Who are the external “regulators/ gate-keepers”?
• The European Medicines Agency • The Biocidal Products Committee/ European Chemicals Agency • National Competent Authorities (e.g. AIFA, BfArM, DIKLZ, FAMHP, FDA, HPRA, MHRA, URPLWMiPB) • Notified Bodies (e.g. BSI, LRQA, NSAI, SGS Belgium, TÜV NORD) • Trade Associations: ● Biocides: EFTA, ● Cosmetics: Cosmetics Europe, CTPA ● Medicines: EFPIA, EuropaBio, Animal Health Europe, Pharma.be, BAH ● Medical Devices, ABHI, BIVDA, BVMed, EMIG, Eucomed, MedTech Europe
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Some gatekeepers suggested by you
• Regional team – supporting a local issue or product roll-out • Local affiliate – regional team may need to negotiate and brief on meeting with a national authority • Local exporter/ importer • Authorised representative (for medical devices) • Research Ethics Committee • Health Technology Assessment Institute • Other company – divestment, due diligence, licence acquisition • Quality Assurance • External manufacturer
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• Build and maintain relationship with your ‘key customer’ • Establish trust – be truthful and objective • Establish early dialogue if possible • not too early, plan first • do not wait until there are issues or the issues worsen • Be wary of agency metrics for responding • Anticipate issues and jointly resolve problems, before they become serious • Share the logic of regulatory strategy and if relevant, development plan • Communicate new data • Monitor changes in regulator’s attitude or expectations of data Recap: Why have interactions with your regulators?
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Time for a quick breather
Before moving on to the next section List the gate keepers that matter to you: In both your professional and personal lives
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RESOLVING CONFLICT Back to the Theory and Practice
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Conflict
A situation when the interests, needs, goals or values of involved parties interfere with one another. • In workplaces, conflicts can be common and inevitable. Different stakeholders may have different priorities; conflicts may involve team members, departments, projects, organisation and client, boss and subordinate, organisation needs vs. personal needs. Often, a conflict is a result of perception. • Is conflict a bad thing? Not necessarily. A conflict may well present an opportunity for improvement or to reset understanding.
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Five techniques for resolution of conflict
1. Forcing 2. Compromising 3. Withdrawing 4. Smoothing 5. Collaborating
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Conflict resolution techniques - Forcing (competing)
Pushing one viewpoint at the expense of another or maintaining firm resistance to another person’s actions • Appropriate when a quick result is vital, when standing up to aggression or when less forceful methods ineffective • As a last resort to resolve a long-standing conflict
See next slide for advantages and disadvantages
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Forcing (competing) – Pros and Cons
Disadvantages May negatively affect your relationship with the opponent in the long run May escalate the conflict (cause the opponent to react in the same way) Cannot take advantage of the strong sides of the other side’s position Taking this approach may require a lot of energy and self confidence
Advantages May provide a quick resolution to a conflict Increases self-esteem Draws respect when firm resistance or actions were the response to aggression or hostility
2109-Sep-19
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Conflict resolution techniques - Compromising (reconciling)
Looks for an expedient and mutually acceptable solution which partially satisfies both parties • Appropriate to reach temporary settlement on complex issues • To reach expedient solutions on important issues • As a first step when the involved parties do not know each other, or still need to develop a high level of mutual trust • Advantages ● Faster issue resolution ● Can provide a temporary solution while still looking for a win-win solution ● Lowers the levels of tension and stress resulting from the conflict • Disadvantages ● May result in neither party being satisfied (a lose-lose situation)
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Conflict resolution techniques - Withdrawing (avoiding)
Not addressing the conflict but side-stepping, postponing or withdrawing • Appropriate when issue not worth the effort, more important issues are pressing, you don't have time to deal with it or it is not the right time or place to confront the issue • When you see no chance of getting your concerns met or when dealing with hostility or if you are too emotionally involved or others can handle it better • Advantages ● Can postpone until circumstances more favourable for you to push back ● Time to better prepare and collect information before you act • Disadvantages ● May lead to weakening or losing your position ● Not acting may be interpreted as an agreement. ● Negatively affect your relationship with a party that expects your action
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Conflict resolution techniques - Smoothing (accommodating)
Putting the concerns of other people first, rather than prioritising one’s own • Appropriate when it is important to provide temporary relief from conflict or to buy time until you are in a better position to respond • When the issue is not as important to you as it is to the other person • When you accept that you are wrong or you have no choice or when continued conflict would be detrimental • Advantages ● Protect more important interests while giving up on some less important ones ● Provide an opportunity to reassess the situation from a different angle ● As a rule, does not require much effort • Disadvantages ● Need to use judiciously or risk being taken advantage of ● Might affect your confidence in ability to respond to an aggressive opponent ● Makes it more difficult to transition to a win-win solution in the future
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Conflict resolution techniques - Collaborating (Win-Win)
Confronting the problem at hand and finding the solution that most satisfies the concerns of both parties • Appropriate when consensus and commitment of other parties is important, addressing the interests of multiple stakeholders, when a high level of trust is present or long-term relationship is important • When you need to work through hard feelings, animosity, etc. • Advantages ● Sharing of responsibility for the outcome ● Reinforces mutual trust and respect ● Builds a foundation for effective collaboration in the future ● You earn a reputation as a good negotiator • Disadvantages ● Takes up significant time and effort
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Crossing the divides – even at work
• Negative opinions about someone takes up energy and diverts attention away from your job. It might even get in the way of making the right decisions • Unless you are lucky, it rarely gets better by itself, so trade short term pain for long-term gain. • Consider what impressions you give to others at work. What you consider to be modesty and thoughtfulness could be interpreted as aloofness • Show that you want to understand your colleague’s perspective. Ask for their point of view, and summarise back what they have said • Be yourself; be open and honest • If it ever becomes heated, try at least to be factual
https://www.bbc.com/ideas/videos/how-to-get-on-with-someone-you-hate-at-work/p072bwd0
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The project leader’s conflict armoury
1. Forget about winning or being right 2. Look for a root cause, not a person to blame 3. Name your emotion (I am upset because…..) 4. Invite the other party to collaborate
5. Keep things goal-oriented 6. Meet face-to-face if you can 7. Identify an individual’s source of frustration and recognise it aloud to them 8. Admit you were wrong, or what you could have done better 9. Focus on behaviour, not personality, but avoid saying “you said, you did” 10. Clear channels for peer feedback and open conversation
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UNDERSTANDING YOUR AUTHORITY/ GATE-KEEPER (WHEN AND FROM WHOM TO SEEK ADVICE)
20-Sep-19
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Recap: General scientific or procedural advice can be obtained for …
• Questions relating to the interpretation and implementation of (draft) guidelines, (draft) pharmacopoeia monographs • Emerging and new medical therapies • Evidence to support product claim(s) • Product classification (e.g. MD vs medicine) • Legal basis for proposed MAA • On methodological questions (e.g. release testing, bioquivalence)
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Recap: Product specific scientific advice can be obtained for …
• Environmental risk • Use of ingredients • Advertising copy • Development strategy to optimise drug development • Quality Target Product Profile (QTPP) • Clinical protocol assessment • Clinical programme design • Extension of indication • PIPs • Post-authorisation / FUM*s / PSURs / line extensions
* Follow-up Measures
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Your turn What kinds of interactions with your regulators/ gatekeepers occur at the various points of time during life cycle of a regulated product?
Product Development
Post Approval
Approval
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Why do regulators give guidance?
e.g. Dutch Medicines Evaluation Board (MEB) It is in the interest of patients, for applicants to generate a robust dataset that helps in the benefit/risk assessment To stimulate innovation and give guidance to companies, also small (national) companies Opportunity for assessors to get information on new developments in medicine development in early phase
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Your interactions with regulators should be …
• Planned early • Part of a global regulatory development plan • BUT don’t forget
• Consultations with regulators are formal occasions and opportunities are limited. Visits must be seen as justified and worthwhile by both company and regulator. It may not be appropriate to solicit advice in all cases • Remember slide in previous webinar on whether you need to meet face-to-face
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If you choose national scientific advice
Questions should be related to ● Future development of product
● Data package and best chance to obtain MA ● Choice of procedure, interest to be RMS Also available for herbal medicinal products and medical device with supporting pharmaceutical product Restrictions • Controversial questions or new topics will be referred to EMA for EU scientific advice • MRP/DCP, only if the NCA is asked to be RMS
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Limitations to national scientific advice
• Restricted to scientific issues • Regulatory aspects (e.g. legal basis for submission, GCP/GLP/GMP related questions, format of application) should be the matter of a separate request (pre-submission meeting) • Prior agency advice is not legally binding for future marketing authorisation applications • Advice does not address ethical questions, e.g. whether a trial is acceptable in view of patients’ rights and safety • Different national regulators can give different advice, but joint advice with another regulator is possible • Mentioned in the EPAR
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Respect cultural differences but not stereotypes
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Interactions with regulatory authorities/ gate keepers
• Do your homework on regulations and guidelines relevant to audience – What is the reason behind the interaction!! – Use legislation and regulations to your advantage – Obtain an understanding of any possible ‘political’ context, so you can “read between the lines”. • Interaction – Be respectful – Be prompt in responses. – Be prepared to lead the discussion (try not to follow)
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Approach to Interactions
• Use the regulations and guidelines as justification of approach – Interpretation may be subjective, there is often more than one approach or justification – Regulations or guidelines may be new – Be prepared to discuss the regulation/ guideline as it pertains to your product – New regulations and guidelines are coming out all the time, as new products and new approaches are presented to the authorities, the old days of “This is how it’s always been done” is no longer applicable. Don’t accept it!!! ● Use the meetings and conversations as an opportunity to educate the authorities on your product – Don’t expect them to have built-in knowledge. – Understanding your product also means understanding your approach or response
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Communications with EU Authorities/ Gate Keepers
• Be honest in your interactions – Back tracking never looks good
• Communicate openly but don’t over share!! – For example, challenges in product engineering or development are not always problems agencies can resolve • Methods of communication – Create briefing package for discussions – Face-to-face when possible or via video conferencing (e.g. WebEx, MS Teams) – Phone and email
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SEEKING ADVICE FROM AN AUTHORITY
Decide in the following scenarios where you would first go for advice
Your turn first
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Where do you go for advice?
You want to discuss your primary endpoint for your proposed clinical study and the level of statistical advantage needed to show efficacy
Notified Body or Competent Authority or Consultancy or CRO
CRO
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Where do you go for advice?
CMC for a new modified release formulation
To establish the “DESIGN SPACE” for its Quality Target Profile (QTPP) in pharmaceutical development (ICH Q8)
National CHMP or National Advice?
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Where do you go for advice?
Herbal extract
You have questions regarding the viral safety prior to initiating clinical trials
HMPC/CHMP or National?
National, e.g. PEI (Germany) or ANSM (France)
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If national advice – how do you choose the country?
• Expertise in a particular therapeutic area, class of drugs or scientific advances • Recognition of disease or therapeutic area in country • Is the particular country one of the major markets for the product • Accessibility of the regulator - ease and speed to arrange a meeting • Company’s own experience BUT • Risk of receiving differing advice, if it is sought from different countries Don’t expect to be able to circumvent any advice you don’t like
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What are alternatives to scientific advice?
• These might be typical sources of background research for possible SI Meeting or even replace the need for such a meeting! • EMA press releases • Update of scientific guidelines • EPARs
• CMDh’s website-database on referrals • External consultants or other bodies • Trade Associations
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Remember …
… interactions should be planned early and should be part of a regulatory development plan
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But …
… there can also be spontaneous interactions by phone, if you know your regulator and you want to have his/ her opinion or advice
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For your briefing you need to consider
Advice from your regulator is only as good as background information provided and questions posed Therefore, your briefing should ● make thinking visible – enable for the reviewer to follow the trail ● have a ‘story line’ that leads the reviewer to conclusions ● be comprehensive enough to put reviewer in a position to make a valid decision on company’s proposal – provide main arguments, clear justification and all necessary data ● be short enough – only information to support specific questions to be discussed – too much documentation only impedes meaningful and timely review of information ● be realistic, raise problems, if they exist
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