2017 TOPRA Annual Symposium

HUMAN MEDICINES PROGRAMME (14 July 2017)

Working Party Susan Bhatti – Merck KGaA, Germany Anne De Bock – AstraZeneca, Belgium João Duarte – Lundbeck, France Sharon Gorman - Pfizer, UK (Chair) Margareth Jorvid – LSM Group, Sweden (co-chair) Carlos Langezaal – Eisai, US Ian Laws – KAIG Consulting, UK Shaun Stapleton – Reneuron, UK Nick Sykes – Pfizer, UK MHRA: Mark Birse Michael Kipping Dan O'Connor Angeliki Siapkara Michael Dykes Andrew Queen Sam Menage For parallel sessions: Veterinary medicines WP chair: Beate Lohr - KLIFOVET AG, Germany Medical devices WP chair: Margareth Jorvid – LSM Group, Sweden

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Monday 2 October 2017 11.30–12.30 12.30

Registration, exhibition and refreshments Welcome to 2017 Symposium Bob Clay – TOPRA President, UK; Dr Ian Hudson - CEO, MHRA, UK

12.40 TOPRA Annual lecture 2017 Dr Murray M. Lumpkin - Deputy Director – Integrated Development (Regulatory Affairs), Lead for Global Regulatory Systems Initiatives, Global Health | Integrated Development, USA SESSION 1: Delivering the European Network Strategy – progress to date Leader: Shaun Stapleton –Reneuron, UK Two years ago, the Heads of Medicines Agencies and European Medicines Agency adopted their high-level strategy to 2020. This ambitious strategy set out plans and priorities for the years ahead. What progress has been made so far? What are the network’s priorities as we move into 2018 and beyond?

Chair: Dr Ian Hudson - CEO, MHRA, UK 13.15

13.20

Introduction: part way through the ambitious Multi Annual Work Plan (MAWP), the landscape has changed resulting in a refocus on our priorities for the next year Ian Hudson – CEO, MHRA, UK HMA MAWP: Achievements and Priorities for 2018 Kristin Raudsepp – Director General State Agency of Medicines, Estonia

13.45

EMA MAWP: Achievements and Priorities for 2018 Agnès Saint-Raymond – Head of International Affairs, EMA, UK

14.10

Panel discussion moderated by chair with today’s speakers plus invited guests – this is your opportunity to explore the topic more fully.

14.45

Break

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SESSION 2: Ensuring timely regulatory approval of medicines and access for patients Leader: João Duarte – Takeda, UK Following the global push to accelerate regulatory review, increase stakeholder involvement and optimise evidence-based drug development, this session considers initiatives that expedite the approval process and improve access to medicines .

Chair: João Duarte - Associate Director, Europe Regulatory Policy & Intelligence Global Regulatory Affairs, Takeda Development Centre Europe Ltd, UK 15.15 15.20

Introduction How EMA is supporting drug developers in ensuring regulatory strategies address unmet medical needs?

Michael Berntgen - Head of Product Development Scientific Support Department, EMA, UK  The experience so far from the Priority Medicines scheme (PRIME).  Perspectives in the expedited tools in the EU (CMA, Accelerated Assessment).  How enhanced dialogue is being carried out in drug development (HTA-parallel scientific advice, adaptive pathways) and next steps.

15.40

HTA Bodies as regulatory partners in patient access: how to ensure alignment in evidence expectations?

Emily Crowe – Technical Adviser, National Institute for Health and Care Excellence (NICE), UK  HTA bodies increasing advice provision to drug developers: already a routine partner?  What bottlenecks are found at HTA step that could have benefited from earlier stakeholder alignment?  How is European collaboration with regulators seen in the near future (e.g. EUnetHTA).  Current experience with EAMS scheme in the UK on access.

16.00

Industry views on current challenges and opportunities on timely approval and access to patients Simon Bennett - Director, Global Regulatory Policy EU Lead and GEMS Interim Lead, Biogen, UK   

What is the industry view on the latest developments in the EU on this (from national schemes to SMART EC discussions.)

Do we have good examples on how industries can fully align their development dialogue with authorities (i.e. case studies with PRIME, Sci-HTA advice.)

Which challenges and opportunities can schemes such as these bring?

16:20

Panel discussion with this session’s speakers moderated by chair with above speakers and invited panellists

16.45

Tea/Coffee break

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SESSION 3: Regulatory collaborations on the world stage Leader: Carlos Langezaal - Eisai Inc, USA The EMA, US FDA and Japanese PMDA are working together to deliver better regulatory processes and healthcare – and the impact of the Bill & Melinda Gates Foundation work.

Chair: Carlos Langezaal - Director, Global Regulatory Affairs, Eisai Inc., USA 17.15

Introduction

17.20

The Office of International Programs within the Japanese PMDA and the collaborations between the PMDA and EMA and other Asian Health Authorities Kondo Hideyuki - PMDA Liaison at the EMA, Japan  Update on the Office of International Programs of the PMDA  Collaborations between the PMDA and EMA  Collaborations between the PMDA and other Asian Health Authorities

17.40

Update on the collaborations between the FDA and EMA Sabine Haubenreisser - EMA liaison, FDA 

18.00

Overview of the various areas of collaborations between EMA and FDA, such as Cluster meetings, GMP inspections, parallel scientific advice, etc.

How International Collaborations can save lives and improve health Dr Murray M. Lumpkin - Deputy Director – Integrated Development, (Lead for Global Regulatory Systems Initiatives), Bill & Melinda Gates Foundation, USA

18.20

Panel discussion with this session’s speakers

18.45

Symposium Networking Dinner – meet your colleagues for drinks and dinner with the 2017 theme in the Exhibition Hall

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Tuesday 3 October 2017 08.55 Introduction to Day 2 – TOPRA SESSION 4: Post Approval Data and the future role of Real World Evidence in regulatory decision making Leader: Ian Laws – Director, KAIG Consulting, UK There has been much discussion over recent years of both the potential value of Real World Data (RWD) and its possible role in the regulatory decision making process. The term Real World Data has been widely used, but often not well defined and examples of the use of RWD could be considered to be limited both in number and scope.

This session will seek first to categorise RWD and a potential hierarchy of value in the regulatory decision making process. Following this foundation, there will be a more detailed look at the practical challenges of one RWD example data source, Registries. The session will complete with an extended senior panel discussing the opportunities, challenges and potential roadmap for the future use of all forms of non-randomised controlled trials data in both the current post approval paradigm, and possible options in the pre-approval arena.

Chair: Ian Laws - Director, KAIG Consulting, UK 09.00

Introduction

09.05

A regulatory grounding in Real World Evidence Alison Cave – EMA, UK Sources of RWD and a potential hierarchy of value in the regulatory decision making process Robert Hemmings – MHRA, UK Exploration of one source of RWD, Registries: Some practical considerations for incorporation into development and post approval regulatory strategy Andrew Rodham – VP Epidemiology GSK, UK  What is the current experience, challenges and lesson for the use of registry data in regulatory decision making?  Prospective registry design considerations  Potential pitfalls and issues with registries when compared to RCTs  Thinking ahead, the challenges and possible opportunities for pre-approval use?

Panel discussion moderated by chair with above speakers plus other invited guests

10.30

Break

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SESSION 5: Involving patients in drug development and how this impacts on regulatory procedures and decision making Leader: Susan Bhatti - Merck KGaA, Germany Health agencies are actively engaging with patients to incorporate their values and preferences into the scientific review process – but industry is often less clear about how to manage effective patient participation and patients themselves can find the regulatory process frustrating. Hear about the initiatives and challenges facing all stakeholders first hand.

Chair: Susan Bhatti – Director Director EU Global Regulatory and Scientific Policy, Global Regulatory Affairs, Merck KGaA, Germany 11.15

Introduction

11.20

How to reflect the needs of patients in drug development programmes Kirsten Lerstrøm – Lupus, Denmark   

11.45

Patient input on study design and protocol: when and how?

Informed consent process Information on approved medicines – what do patients need?

Regulatory Agencies perspectives on involving patients in drug development and decision making Juan Garcia Burgos – Head of Public Engagement, EMA, UK EMA initiatives to involve patients in the review and decision making process:  Incorporating patients' values and preferences into the scientific review process, in particular in benefit-risk evaluation at CHMP  Outcome of the pilot phase of patient involvement in CHMP oral explanations and research projects on elicitation of patient preferences  How will EMA to report patient input and values in the relevant assessment reports, in line with the EMA AddValue project?  Plans to improve provision of information to patients and prescribers European Commission report on shortcomings (maybe address “smarter” methods of providing PIL info here – link to device session on smarter medicines?)

12.05

Incorporating patient preferences in drug development – an industry perspective Industry position on advantages and challenges of involving patients in the drug development process Andrea Beyer - Director of Innovus Consulting Ltd for Actelion Pharmaceuticals Ltd, Switzerland   

Case study Impact on regulatory approval & reimbursement IMI Prefer project

12.25

Panel discussion: This session’s speakers will take questions from the floor.

12.45

Lunch

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SESSION 6: Regulatory science – turning theory into practical advantage Leader: Sharon Gorman – Pfizer, UK As drug development becomes ever more complex, regulatory decision-makers in Europe and the US are increasingly looking to regulatory science for solutions. How can academia, industry and regulatory agencies work together to deliver initiatives that ensure that regulatory science has practical input into drug development.

Chair: Prof Dr Bert Leufkens – Former Chair MEB, Chair at Utrecht University on ‘Regulatory Science and pharmaceutical Policy’ 14.00

Introduction: Defining Regulatory Science and Setting the Scene Christine Gispen – Head Scientific Programme Board, MEB, The Netherlands  Definition(s) of Regulatory Science  The European Landscape

14.25

Regulatory Science Network Netherland (RSNN) Just Weemers – Pfizer, Netherlands   

Introduction to the Network Achievements to date Plans for the future.

14.45

Innovative Medicines Initiative Magda Chlebus – Director Science Policy, European Federation of Pharmaceutical Industries and Associations, Belgium  Brief overview of the current and planned IMI2 projects which will facilitate regulatory science e.g. ADAPT SMART, PREFER, Get Real etc.  Discuss how these projects are (or will) change drug development and regulatory assessments.

15.00

The practical application of Regulatory Science: Impact on Regulatory Policy and Regulatory Practice Larry Liberti – Executive Director, CIRS (Centre for Innovation in Regulatory Science)

15.30

Panel discussion moderated by chair with invited guest: Tony Humphreys, Head of Procedure Management & Committees Support Division, EMA – the speakers will take questions from the floor.

Break

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SESSION 7: Legislative updates affecting clinical trials, paediatrics and falsified medicines Leader: Nick Sykes – Pfizer, UK Get the latest information on key legislative changes affecting medicines regulation in Europe and progress on their timelines, implementation and progress to date.

Chair: Nick Sykes – Pfizer, UK 16.05 Implementation of the Clinical Trial Regulation from a commercial sponsor’s perspective Rose-Marie Swallow – Bayer, UK An overview of the key issues to be considered by sponsors before they can finalise their plans to be ready for when the Regulation takes effect. Potential solutions to some of these issues will also be highlighted.  CT Portal and Database  National approaches  Documentation expectations  Safety issues 16.10

Paediatric regulation: Commission consultation following 10 years of operation Florian Schmidt - EU Commission The report on Commission consultation should be ready by September 2017 and the key points will be shared in this session alongside the proposed next steps from the Commission.

16.25

Safety features required by the Falsified Medicines Directive Industry speaker invited  Serialization  Tamper evidence

17.10

Panel discussion moderated by chair – The speakers will take questions from the floor.

17.35

TOPRA Board Update and Student Poster Winners Announced

18.15 19.15

Networking drinks in Exhibition Hall followed by freedom to explore London

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Wednesday 4 October 2017 Introduction to Medical Devices Symposium and Joint Human Medicines Sessions Margareth Jorvid – LSM Group, Sweden Session 8: [Combined Human Medical and Medical Devices] – Medicinal products incorporating device components – significant change ahead Leader: Janine Jamieson – JCombinations AB (and TOPRA Med Tech SPIN Chair), Sweden The new Medical Device Regulation will amend medicines regulation to involve notified bodies in review of medicinal products incorporating integral medical devices. At the same time, EMA is proposing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product, highlighting the increasing importance of such combinations in healthcare treatments.

Chair: Janine Jamieson – JCombinations AB (and TOPRA Med Tech SPIN Chair), Sweden 09.00 Introduction 09.05

EMA perspective on increasing focus on review of device components of medicinal products Armin Ritzhaupt - Regulatory Affairs Officer, EMA   

09.25

Feedback from CHMP QWP/BWP draft Concept paper on developing guidance on Quality of drug-device combination products The new Medical Device Regulation – amending medicines legislation to require review by notified bodies for some integral device components Experiences from collaborations with notified bodies

Notified Body perspective and advice on when and how to engage notified bodies Theresa Jeary – LRQA, UK  

Current reviews of drug delivery devices for conformity with safety and performance requirements How will review of integral devices differ from current procedures?

Advice for pharma and device manufacturers on timelines and data expectations for notified body assessment

09.45

Global perspective – update from the FDA Office of Combination Products, including working with other regions towards harmonisation of requirements FDA speaker invited  Current focus on combination and ‘complex products’ at FDA  Combination products Policy Council and the intercenter consult process pilot – building relationships between drug and device reviewers  FDA Final Rules and Guidances on cGMP and Post-market Combination Product Safety Reporting

10.05

Panel discussion moderated by Janine Jamieson – The speakers will take questions from the floor with invited panelist Elizabeth Baker, MHRA Group Manager Licensing Division, MHRA, UK

10.30

Break

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SESSION 9: [Combined Human Medical and Medical Devices] – Personalised medicine: in vitro diagnostics and companion diagnostics Leader: Nick Baker – LRQA, UK A look at the new IVD Regulation and its potential impact on industry, e.g., under the new classification and conformity assessments most IVD assays be reviewed by a notified body.

Companion diagnostics also have their own particular conformity assessment requirements requiring notified bodies to consult either with the EMA or competent authorities. How will this work in practice for pharmaceutical and diagnostic manufacturers?

Chair: Nick Baker – Technical Manager, LRQA,UK

11.15

Introduction

11.25

An Overview of the new IVDR Nick Baker – LRQA,UK  New classification system  Consultation process  Workload challenges

11.45

Competent Authority Perspective Daryl Colombage - Senior Medical Device Specialist, MHRA, UK

12.05

Challenges for Industry Peter Martin, Roche Diagnostics, UK

12.25

Panel discussion moderated by Nick Baker, with this session’s speakers and invited panelist Armin Ritzhaupt - Regulatory Affairs Officer, EMA taking questions from the floor.

12.45

Light lunch

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SESSION 10: UK exit from the EU Leader: David Jeffries – Eisai, UK The impact of the UK’s decision to leave the EU will be significant on the pharmaceutical and medical devices industry as well as the EMA and the MHRA. The process to withdraw will be complex and will take at least 2 years to complete. Although the final outcomes are as yet unknown, this session will consider preparations being made by the MHRA and EMA. Potential impacts on the UK and European industries will also be discussed in the light of emerging scenarios.

Chair: David Jeffries – Senior Vice President, Eisai, UK 13.45

Introduction David Jeffries – Senior Vice President, Eisai, UK 

What is known to date and what is still to be determined

How are the EMA preparing and what has been decided so far Noel Wathion – Deputy Executive Director, EMA, UK MHRA preparations made to date and process for the future discussions MHRA speaker – name TBA  An overview any preparations MHRA have made to date, given the remaining uncertainties 

To provide the audience with information on what process and communication from the MHRA can be anticipated in the coming months.

Pharmaceutical Industry views and the possible future impact for the pharmaceutical industry Virginia Acha - Executive Director – Research, Medical & Innovation, The Association of the British Pharmaceutical Industry, UK

Medical Device Industry Views and the possible future impact for the devices industry Neil R Armstrong – CEO, MeddiQuest, UK Panel discussion moderated by chair – This session’s speakers will take questions from the floor.

15.15

Closing remarks by MHRA

15.25 15.30

Close of Symposium by TOPRA President End of Symposium

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Tuesday, 3rd October 2017 PARALLEL SESSION: Latest thinking on Adaptive Pathways, Life Cycle Management and ICH Leader: Meike Vanhooren – Pfizer (and CMC SPIN Chair), Germany This session will focus on how new drug development paradigms and expedited patient access impact on CMC and reflect on current challenges:  Accelerated clinical development programmes will decrease the amount of time available for the development and understanding of the drug substance, the drug product and their associated processes; therefore, there must be a strategy to ensure that the critical aspects of Chemistry, Manufacturing and Controls (CMC) provide assurance that safety and quality will not be compromised.  Regulatory processes are complex and not always risk- based, leading to unnecessary delays in manufacturing improvements and intensive use of resources. These challenges in lifecycle management can, i.e. lead to disruption in supply chain and drug shortage. ICH12 aims to facilitate the management of post approval changes in CMC in a more transparent, predictable and efficient manner across the product lifecycle.

Chair: Meike Vanhooren – Senior Director Global CMC, Pfizer, Germany Introduction 09.00 09.05

Accelerated Pathways – CMC considerations on starting materials, validation strategy, stability and continuous manufacturing.

Sarah Fitzgerald - Director Global CMC, Pfizer  

09.30

Accelerated clinical timelines could lead to insufficient time to complete all “traditional” CMC studies for approval Employing a more flexible filing processes; such as leveraging developmental data and risk assessments in lieu of some commercial scale experience

ICH Q12 & reduction in post approval complexity Frank Montgomery - Astra Zeneca, UK  Understand the new opportunities and potential flexibility implementation of ICHQ12 will bring for CMC lifecycle management

10.00 10.30

Panel discussion moderated by chair with today’s speakers plus invited guests – this is your opportunity to explore the topic more fully.

Break

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Tuesday 3rd October 2017 PARALLEL SESSION: CMC regulatory requirements in low income countries Leader: CMC SPIN It is often difficult to find current information on CMC regulatory and CMC procurement requirements in low income countries (LICs). This lack of information and the complexity of trying to develop products for multiple markets can lead to significant delays and costly missteps in product development programmes. Under the leadership of the TB Alliance, the Bill and Melinda Gates Foundation, and PWC, a new data base has been developed in conjunction with WHO and many of the LIC regulators and major procurers. Analysis of the data base has revealed some areas that are ripe for further alignment that would potentially expedite product development without compromising product quality. Efforts are underway currently to try to prioritise those areas with the greatest potential for positive global health impact for further alignment initiatives.

Chair: Meike Vanhooren - Pfizer, Germany Introduction 11.15 11.20

Introduction to the CMC regulatory requirements in low income countries Rajneesh Taneja -Senior Director, Pharmaceutical Product Development, TB Alliance, USA Workshop discussion moderated by chair - how might these pain points compare to those seen in high income countries and what can we learn from this.

12.50

Close of session, lunch

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Wednesday 4 October 2017 PARALLEL SESSION: Clinical Trial new regulation implementation Leader: Satinder Chettra – Alnylam (and CT SPIN Chair) This session begins with a review of the EMA portal and the testing, an agency perspective on preparing for the CTR e.g. with their pilot scheme, followed by industry experience of pilot scheme.

Chair: 1.5 hours

Introduction 1. EMA experience on Portal and Testing a. To detail what the portal will cover b. Who has access and responsible for data input c. How the testing phase has gone, what challenges have they faced? d. When they believe it will be ready to go live 2. MS competent authority to discuss their plans for CTR implementation and pilot schemes a. What the agency is doing specifically to meet the CTR implementation timeline b. If they are running a pilot scheme, to provide some metrics on the scheme and success rates c. What challenges have they faced d. When they believe their scheme or something similar can be implemented for the Oct 2018 deadline.

3. Session to finish with detailed discussion to summarise the differences and similarities at an EU vs. MS level Symposium closes

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Monday- Wednesday October 2017 PARALLEL SESSION: Professional development Leader: Samantha Alsbury – TOPRA, UK

Various aspects will be explored on your profession including TOPRA plans, leadership skills, volunteering, certified agency training, CSci and RSci workshop and CPD Tuesday 3 October 12:45 13:00

Enhancing regulatory careers - how TOPRA is supporting your regulatory professional development Tacye Connolly – TOPRA, UK

14:00 15:30

Skills development for current and future leaders: improve your leadership skills. A practical workshop (Max 20 participants) Alison Dixon – Success Coaching & Development Ltd, UK

Wednesday 4 October 09:00 09:30

09:30 10:00

10:00 10:30

11:15 12:30

13:05 13:30

TOPRA Competency Framework: We need your input!

Samantha Alsbury – TOPRA, UK; Daniela Drago - George Washington University, USA How diversity in regulatory affairs makes it a better career for everyone Sinéad Whelan – TOPRA, UK Career progression  How to use volunteering to develop your skills  Volunteering in action: SPIN communities case study (Martin Lanigan and Kellie McLeod – Young Professionals SPIN group) Sinéad Whelan – TOPRA, UK Ensuring regulatory scientists gain professional recognition: a workshop on Chartered Scientist (CSci) accreditation Angela Stokes – INC Research and TOPRA president elect, UK; Samantha Alsbury – TOPRA, UK Developing the next generation of regulatory affairs professionals: a certified training programme Michael Kipping - MHRA, UK

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MEDICAL DEVICES PROGRAMME

Working Party Margareth Jorvid – LSM Group, Sweden (Chair) Michael Kipping – MHRA, UK Janine Jamieson – JCombinations AB, Sweden Tim Chesworth – Astra Zenenca, UK Gert Bos – Qserve Group BV, The Netherlands Nick Baker – LRQA, UK Theresa Jeary – LRQA, UK

Tuesday 3 October 2016 Medical Devices Symposium 10.30-11.00

Registration, exhibition and refreshments

11.05

Introductions to Medical Devices Symposium Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden

SESSION 1: Optimising the implementation of new MDR Leaders: Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden

An overview of the future regulatory framework and the key changes in the new Medical Device Regulation (MDR). What will their impact be on industry and how can organisations best prepare to deliver the new requirements within the timelines?

Chair: Margareth Jorvid – Methra Uppsala AB, LSM Group, Sweden 11.15 Introduction 11.20

The new Medical Device Regulation Erik Hansson- Deputy Head of Unit, Directorate General for Internal Market, Industry, Entrepreneurship and SMEs Health Technology and Cosmetics , European Commission   

11.45

The new MDR – What does the new Regulation include?

Timelines for implementation Development of guidelines

Implementation challenges, how to prepare Céline Bourguignon - Director Global Regulatory Policy, Johnson and Johnson, Belgium   

12.10

Consequences for industry Preparation Transition period

Longer Panel discussion “How to work together” moderated by Margareth Jorvid This session’s speakers + speakers of session 2 (Notified Body + Competent Authority) will take questions from the floor.

12.45

Lunch in Exhibition Hall

SESSION 2: Implications of new regulatory oversight requirements Leader: Gert Bos - Qserve Group BV, The Netherlands

The new MDR changes supervision requirements both for notified bodies and competent authorities. There are changes to setting up as an NB, conformity assessment routes and methods of practice. For CAs there are more specific requirements on supervision of NBs, market surveillance, and formulating and approving delegated and implementing acts, as well as common specifications.

Chair: Gert Bos - Qserve Group BV, The Netherlands 14.00

Introduction In recent years, additional instructions and guidance to notified bodies have been issued, resulting in stricter conformity assessment routes. In addition, the 2016 publication of the MEDDEV 2.7/1 rev.4 guidance on clinical evaluation has further enhanced the expectations to keep products on the market. Key players from authority and notified body side will explore their new level of expectations, and will provide guidance and explanations to the audience.

14.05

Impact on Notified Body Bassil Akra - Director - Global Clinical Focus Team, Clinical Centre of Excellence (cCE), TÜV SÜD Product Service GmbH, Germany

  

14.30

Important steps towards a successful notification according to the new regulation Impact of the guidance document on the medical device manufacturer portfolio New duties of the notified bodies during the approval process and postmarket surveillance activities

Impact on Competent Authority John Wilkinson – Director of Devices Division, MHRA, UK

  

14.55

New responsibilities for competent authorities Expanded or more specific extensions to current responsibilities Role of CA’s in more complex set of necessary collaborations across the system and the product life cycle

Longer Panel discussion moderated by Gert Bos This session’s speakers + speakers of session 1 (Commission + Industry) will take questions from the floor.

15.30

Break End of Session 2

SESSION 3: Embracing the digital healthcare revolution Leader: Tim Chesworth - AstraZeneca, UK The effective use of apps, connected devices and other digital support services has the potential to have a profound and positive impact on patient outcomes. Regulators recognise this and are trying to adapt in a rapidly changing technological environment. Where do regulators and industry need to collaborate further to ensure patients can realise digital health benefits in a timely but safe and controlled manner.

Chair: Tim Chesworth - AstraZeneca , UK 16.05

Introduction

16.10

The UK MHRA Valerie Field – Group Manager, Devices Regulatory Group, MHRA, UK 

16.30

The MHRA Guidance

Industry Perspective

Kirsten Paulson - Pfizer, USA

16.50

Software company perspective

17.10

Panel discussion moderated by Tim Chesworth – This session’s speakers will take questions from the floor

17.30

End of Session 3 – Delegates move to Human Medicines Symposium

17.35 18.15 – 19.15

TOPRA Board update and student poster winners announced Networking drinks in exhibition hall followed by freedom to explore London

Wednesday 4 October 2017 Session 4: [Combined Human Medical and Medical Devices] – Medicinal products incorporating device components – significant change ahead Leader: Janine Jamieson – JCombinations AB, Sweden The new Medical Device Regulation will amend medicines regulation to involve notified bodies in review of medicinal products incorporating integral medical devices. At the same time, EMA is proposing a guideline on Quality requirements of medicinal products containing a device component for delivery or use of the medicinal product, highlighting the increasing importance of such combinations in healthcare treatments.

Chair: Janine Jamieson – JCombinations AB, Sweden 09.00

Introduction

09.05

EMA perspective on increasing focus on review of device components of medicinal products Armin Ritzhaupt - Regulatory Affairs Officer, EMA   

09.25

Feedback from CHMP QWP/BWP draft Concept paper on developing guidance on Quality of drug-device combination products The new Medical Device Regulation – amending medicines legislation to require review by notified bodies for some integral device components Experiences from collaborations with notified bodies

Notified Body perspective and advice on when and how to engage notified bodies Theresa Jeary – LRQA, UK   

09.45

Current reviews of drug delivery devices for conformity with safety and performance requirements How will review of integral devices differ from current procedures?

Advice for pharma and device manufacturers on timelines and data expectations for notified body assessment

Global perspective – update from the FDA Office of Combination Products, including working with other regions towards harmonisation of requirements FDA- invited   

Current focus on combination and ‘complex products’ at FDA Combination products Policy Council and the intercenter consult process pilot – building relationships between drug and device reviewers FDA Final Rules and Guidances on cGMP and Post-market Combination Product Safety Reporting

10.05

Panel discussion moderated by Janine Jamieson – The speakers will take questions from the floor with invited panelist Elizabeth Baker Group Manager Licensing Division, MHRA, UK

10.30

Break

SESSION 5: [Combined Human Medical and Medical Devices] – Personalised medicine: in vitro diagnostics and companion diagnostics Leader: Nick Baker – LRQA,UK A look at the new IVD Regulation and its potential impact on industry, eg, under the new classification and conformity assessments most IVD assays be reviewed by a notified body.

Companion diagnostics also have their own particular conformity assessment requirements requiring notified bodies to consult either with the EMA or competent authorities. How will this work in practice for pharmaceutical and diagnostic manufacturers?

Chair: Nick Baker – Technical Manager, LRQA,UK 11.15

Introduction

11.25

An Overview of the new IVDR Nick Baker – LRQA,UK   

11.45

New classification system Consultation process Workload challenges

Competent Authority Perspective Daryl Colombage - Senior Medical Device Specialist, MHRA, UK

   12.05

IVDR and Companion Diagnostics Performance studies and evaluation Current situation

Challenges for Industry Peter Martin - Roche Diagnostics

12.25

Panel discussion moderated by Nick Baker, with this session’s speakers and invited panelist Armin Ritzhaupt - Regulatory Affairs Officer, EMA taking questions from the floor.

12.45

Light lunch

Continue in Human Medicines Symposium: SESSION 6: The UK Exit From the European Union Leader: David Jefferys – Eisai, UK

The impact of the UK’s decision to leave the EU will be significant on the pharmaceutical and medical devices industry as well as the EMA and the MHRA. The process to withdraw will be complex and will take at least 2 years to complete. Although the final outcomes are as yet unknown, this session will consider preparations being made by the MHRA and EMA. Potential impacts on the UK and European industries will also be discussed in the light of emerging scenarios.

Chair: David Jefferys – Senior Vice President, Eisai, UK 13.45

Introduction David Jeffries – Eisai, UK 

What is known to date and what is still to be determined

How are the EMA preparing and what has been decided so far Noel Wathion – Deputy Executive Director, EMA

MHRA preparations made to date and process for the future discussions MHRA speaker  

An overview any preparations MHRA have made to date, given the remaining uncertainties To provide the audience with information on what process and communication from the MHRA can be anticipated in the coming months.

Pharmaceutical Industry views and the possible future impact for the pharmaceutical industry Virginia Acha - Executive Director – Research, Medical & Innovation, The Association of the British Pharmaceutical Industry, UK

Medical Device Industry Vews and the possible future impact for the devices industry Neil R Armstrong – CEO, MeddiQuest, UK

Panel discussion moderated by chair – This session’s speakers will take questions from the floor.

15.15

Closing remarks by MHRA

15.25

Close of Symposium by TOPRA President

15.30

End of Symposium