2018 Programmes

The 2018 Annual Symposium programmes are taking shape. The latest programmes for the Human Medicines, Medical Devices/IVDs, Veterinary Medicines, Professional Competencies and SME sessions below.

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WEDNESDAY, 3 OCTOBER

Registration and Exhibition

08.30
Introduction to SME Day
- Margareth Jorvid, Methra Uppsala AB/LSM Group, Sweden
09.00 

 

After the introduction to the day, participants choose one of the following three morning tracks, followed by a joint session in the afternoon.

ATMP Human Medicines Veterinary Medicines  
Introduction to ATMP 
 
The Regulatory Role in Early Access Schemes to Patients 
  
Antimicrobial Resistance 
 
09.15 - 10.45  
 
ATMPs  - Cell and Gene Therapies 
 
Clinical Trial Regulation 
 
Advanced Therapies
 
11.45 - 12.45
 

Networking and light lunch in the exhibition hall

12.45 - 13.25

SME Session:
 This session will give small and medium-sized enterprises (SMEs) the opportunity to understand regulatory challenges specific to them as SMEs. Support by the SME Office at the European Medicines Agency (EMA) will be explored and experiences by SME companies shared.
 
13.25 - 15.00 
 
 

 

INDIVIDUAL SESSIONS

 

ATMP Session 1: Introduction to Advanced Therapy Medicinal Products (ATMPs)
ATMPs are defined as gene therapies, somatic cell therapies and tissue engineered products. Since the introduction of the ATMP regulation (EC) 1394/2007 there are a minimal number of ATMPs that are authorised for use. There is a recognition of the specific needs of innovators developing these products and support has been provided with respect to fees and access to scientific advice. In this session we plan to provide an introduction to ATMPs and their associated regulations as background to session 9 on ATMPs.  We will use examples of products that are authorised (where available) to demonstrate the types of ATMPs – cell-based therapies, CAR-T gene therapies and more; opportunities for interaction with EMA and some of the considerations during development and post authorisation that are specific to ATMPs. 

Chair: Jayne Hunt – Associate Director, Regulatory Affairs, Boyd Consultants 

09.15 – 10.45





Introduction 09.15

Main presentation: Introduction to ATMPs

Part 1: Legal definition

  • Differentiation between a biologic and an ATMP
  • Overview of the regulations and directives
  • CAT role


Part 2: Pharmaceutical development roadmap
From small molecules to biologics and ATMPs including CMC controls and regulatory requirement

Part 3: Examples
Cell based, including CAR-T / gene therapy / RNA / Fusion proteins / other

Part 4: Specific considerations
Shedding / Long term follow-up / Traceability / GMO based ATMPs issues and regulations

Part 5: Support for all applicants / SMEs 
Is my product an ATMP - Certification / Scientific advice / Fees / SME office

Speaker: Kathryn Parsley – Associated Director, Boyd Consultants

09.20

Panel Discussion
- Kathryn Parsley – Boyd Consultants
- Hélène Casaert - SME Office, European Medicines Agency
- Jayne Hunt - Boyd Consultants

10.15 – 10.45


Human Medicines Session 1: The Regulatory Role in Early Access Schemes to Patients
Patient access to medicines remains a fundamental objective to all the stakeholders involved in medicines regulation. Even though many challenges such as affordability and pricing of new medicines remain extremely cross-disciplinary, early access schemes (EAS) remain an area where the regulatory professional plays a critical role in ensuring that early patient access is balanced with benefits and risks of innovation. But what are early access schemes and how do these link to regulatory strategies in Europe? This session will shed some light to the current mapping of available early access schemes in EU Member States and how these play an important part in the voyage between medicines regulation and patient access.

Chair: João Duarte – Associate Director, European Regulatory Policy and Intelligence, Takeda

09.15 – 10.45
 



Introduction 

09.15 

An industry perspective on early patient access as a regulatory objective

  • Industry experience on defining early access to patients in regulatory terms
  • Challenges and opportunities in the EU in pursuing early access opportunities and lessons learned from an R&D perspective
  • Reflections on stakeholder engagement from an industry perspective when developing evidence generation to support early access

Speaker: Bharti Navsariwala – Senior Director, EU Regulatory Affairs - Oncology, Takeda 

09.25

How can regulators support early access through R&D and evaluation support?

  • How early is “early” access and how do regulators define trade-off between evidence and marketing authorisation?
  • Available regulatory tools that support development and eventually access (eg, PRIME)
  • How are regulators horizon-scanning and acting on future access challenges? (eg, use of registries, innovative technologies, etc)
Speaker: Tomas Salmonson - Scientific Advisor, Swedish Medical Products Agency; and Chair of EMA's CHMP 

09.45

Is "early" the new standard? A patient’s view on early access

  • Thoughts from a patient representative on the importance of early access, both from available schemes but also from a conceptual perspective
  • What is (and should be) the patient role in defining early access?
  • Current areas where patient input provides value to early access

Speaker: Robert Johnstone – International Alliance of Patients Organisations

10.05 
Panel discussion 
 
10.25 - 10.45

Veterinary Medicines Session 1: Antimicrobial Resistance
The risk of antimicrobial resistance was one of the main drivers for the new veterinary legislation. This risk relates both to efficacious treatment of diseased animals and to public health risk from increased resistance in transmissible bacteria. EU authorities are developing innovative approaches to ensure adequate dosing and efficacy and to control risk profiles of antimicrobials. The outcome and perspectives of these initiatives will be presented. The specific legal proposals related to antimicrobials will be presented, and the future opportunities for handling of infectious diseases will be discussed.

Chair: Anja Holm – Pania Animal Health and CentralVetPharma.com 

09.15 – 10.45



Update from dose optimisation project

  • Antimicrobial resistance – impact for product availability combined with update from dose optimisation project (PPHOVA)
  • SPC harmonisation exercise running now: pre-exercise of new reg. intention
  • Development and consequences

Speaker: Johan Schefferlie - Medicines Evaluation Board (Netherlands)

09.15

European Commission mandate to EMA on early hazard characterisation for new veterinary antimicrobials and public health AMR risk assessment

  • EU COM mandate (given July 2017) for AMEG advice: The mandate relates to updating the categorisation of antimicrobials and development of an early hazard characterisation to encourage development of new veterinary antimicrobials
  • The CVMP’s approach to AMR risk assessment in relation to public health
Speaker: Helen Jukes – Defra and Veterinary Medicines Directorate (UK)

09.35

The new veterinary regulation and antimicrobial resistance

  • A Major objective of new regulation is to control AMR – summary of these legal proposals
  • Reduction of the need for AMs/Alternatives to AMs – how does the new regulation cater for this development? 
  • Restriction of prescription of AMs - Off-label/on-label

Speaker: Fredrik Hultén, Swedish Medical Products Agency 

09.55
Questions and discussion
Session speakers and David Mackay, (formerly) European Medicines Agency

10.15 - 1.45

ATMP Session 2: ATMPs - Cell and Gene Therapies, the Future?

After 10 years with the ATMP Regulation, there are only a handful of approved products on the market. With a great number of products in the pipeline, there are still challenges to overcome, especially for small and medium-sized enterprises (SMEs) and academia. This session will hear about plans and activities to facilitate for developers of ATMPs and about experienced gained by a Swedish SME. Chair: Vera Franzen - Vera Franzen Consulting

11.15 - 12.45

Introduction 

11.15 
European Commission perspective
EU initiatives to support the development of ATMPs

Speaker: Rocio Salvador Roldan - Policy Officer, Unit B5, DG Santé, European Commission

11.20

CAT perspective

  • CAT activities – daily work and new/revised regulatory guidelines
  • Lessons learned
  • Safety – a risk-based approach, patient follow-up and risk management

Speaker: Lisbeth Barkholt - Clinical Assessor, Department of Clinical Trials and Special Permissions, Swedish Medical Products Agency;  and EMA/CAT delegate for Sweden

11.40

An SME regulatory ATMP case study

  • ATMP classification
  • Scientific advice (national, EMA and FDA)
  • EMA ATMP certification

Speaker: Margareth Jorvid - Head of Regulatory Affairs and QA, Immunicum AB

12.00 

Panel discussion
 Session speakers plus invited guests:
- Ilona Reisch – Head of Clinical Trials, Federal Office for Safety in Healthcare (BASG) - Austria
- Marie-Hélène Pinheiro – Industry Stakeholder Liaison, Corporate Stakeholders Department, Stakeholders and Communication Division, EMA
 
12.20 - 12.45

Human Medicines Session 2: Clinical Trial Regulation
The implementation date for the EU clinical trial portal is currently planned for July 2019. After a transitional period of 1 year it will be mandatory to use the portal and database for all new clinical trials in the EU, and after 3 years all trials must be transferred. This session will share the hands-on insights of testers from industry, agencies and ethics committees on the portal and database functionality, as well as experience gathered by the Swedish MPA and ethics committees with their national clinical trial regulation pilot. We will discuss transition guidance documents and the challenges of practical implementation of the legislation. Chair: Susan Bhatti – Merck
11.15 - 12.45



Introduction 

11.15 

CT portal update

Examine the challenges of EU clinical trial regulation implementation from a sponsor’s perspective:

  • Discuss the transition to ‘go live’ of the CT portal and database based on current information
  • Explore the main features of the IT infrastructure, describe how the CT portal and database is being built to accommodate the CT Regulation and identify top issues for implementation
  • Discuss the impact of the draft CTR guidance

Speaker: Christopher Price - Senior Manager, Merck KGaA

11.20

CTR pilot and CTR implementation in Sweden from the HA perspective

  • Update from Health Authority perspective on the CT portal and agency readiness
  • Provide insights on MPA’s CTR joint pilot project

Speaker: Gunilla Andrew-Nielsen - Head of Department of Clinical Trials and Special Permissions, Swedish Medical Products Agency

11.40

CTR pilot and implementation in Sweden from the EC perspective

  • Update from a national EC perspective on the CT portal and EC readiness for implementation
  • Provide insights from an EC perspective on Sweden’s joint pilot CTR project

Speaker: Johan Modin - Swedish EC representative, Swedish Medical Products Agency

12.00 

Panel discussion 
 
12.20 

Veterinary Medicines Session 2: Advanced Therapies
The development of advanced technologies in veterinary medicines requires a well-adapted and adequate regulatory framework and guidance. Projects are often initiated by SMEs with limited experience in the regulatory arena. The session provides an insight on recent experiences and discusses the challenges for both industry and regulators, to make advanced veterinary therapies available for the market.

Chair: Beate Lohr -  Director for Regulatory Affairs - Animal Health, IDT Biologika
 
11.15 - 12.45



Case study: Getting a novel veterinary medicine authorised

  • Initiatives for SMEs – are they fit for the purpose?
  • Experiences along the registration procedure
  • Pitfalls and opportunities

Speaker: Regina Wolf - Head of Regulatory Affairs, Klifovet AG

11.15 

  

Challenges of advanced therapies - an industry perspective

  • Balance between the need for guidance and flexibility
  • Global regulatory cooperation
  • Thoughts on a veterinary-specific approach
Speaker: David John - Technical Manager, AnimalhealthEurope 


11.35

Promoting innovation in the development of novel veterinary medicines

  • How regulation can promote acceptance of novel medicines and new science
  • Ensuring consistency and predictability for current technologies whilst accommodating the needs of novel therapies
  • Developing an approach to classification for novel therapy products
  • Defining the MRL requirements for biologicals
 
Speaker: David Mackay – former Senior Veterinary Advisor at EMA

11.55

Panel discussion

12.15 


SME Session
This session will give small and medium-sized enterprises (SMEs) the opportunity to understand regulatory challenges specific to them. Support by the SME Office at the European Medicines Agency (EMA) will be explored and experiences by SMEs shared.

Chair: Margareth Jorvid – CEO, Regulatory Affairs and Quality Assurance, Methra Uppsala AB/LSM Group
 
13.30 - 15.00



Introduction
13.25 

  

SME Office at the EMA

  • Activities of the Agency's SME Office 
  • Experience of EMA scientific advice process and centralised procedure
  • Support to SMEs  


Speaker: Hélène Casaert - Scientific Administrator, Corporate Stakeholders - SME Office, European Medicines Agency

13.35

Experience of a Swedish SME

  • SME challenges
  • An example of a company's SME journey
  • It may not be possible to follow an optimal EU development path for an SME company, examples
  • Incentives and support helpful to a small company

Speaker: Åsa Holmgren – Executive Vice President, Strategic Regulatory Affairs and Market Access, Medivir AB

14.05

Panel discussion

14.25 

Close of SME Day  15.00