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 

 

 Following 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 ATMPs 
 
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 - 13.30

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.
 
13.30 - 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.

09.15 – 10.45





Introduction 09.15

Main presentation
- Kate Parsley – Associate Director, Boyd Consultants (UK)

09.20

Panel Discussion

10.20 - 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.

09.15 – 10.45
 



Introduction  09.15 

How can regulators support early access through R&D and evaluation support?
- Marie-Helen Pinheiro – EMA

09.25

An industry perspective on how EAS supported early access to innovation
- Bharti Navsariwala – Takeda

09.45
Is "early" the new standard? A patient’s view on early access
- Robert Johnstone – International Alliance of Patients Organisations

10.05 
Panel discussion  10.25

Veterinary Medicines Session 1: Antimicrobial Resistance
One of the main drivers for the new veterinary legislation was the risk of antimicrobial resistance. 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.

09.15 – 10.45



Update on dose optimisation project
- 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
- Helen Jukes – Defra and Veterinary Medicines Directorate (UK)

09.35

The new veterinary regulation and antimicrobial resistance
- Fredrik Hulten, MPA (Sweden)

09.55
Questions and discussion 10.15

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 SMEs and academia. This session will discuss plans and activities to facilitate for developers of ATMPs.

11.15 - 12.45

Introduction 

11.15 
European Commission perspective
- Rocio Salvador Roldan - DG Sante, European Commission

11.20

CAT perspective
- Lisbeth Barkholt - MPA (Sweden)

11.40

An SME regulatory ATMP case study 
- Margareth Jorvid - Immunicum (Sweden) 

12.00 


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 CTR pilot. We will discuss transition guidance documents and the challenges of practical implementation of the legislation. 
11.15 - 12.45



Introduction 

11.15 
CT portal update
- Christopher Price - Merck

11.20

MPA and European Commission - Swedish pilot
- Gunilla Andrew-Nielsen - MPA (Sweden)

11.40

Transition guidance and CTR implementation
- Speaker to be announced 

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. 
11.15 - 12.45



Case study: Getting a novel veterinary medicine authorised
- Regina Wolf - Klifovet (Germany)

11.15 

  
Challenges of advanced therapies - industry perspective
- David John - AnimalhealthEurope (Belgium)

11.35

Promoting innovation in the development of novel veterinary medicines
- David Mackay – formerly of EMA

11.55

Transition guidance and CTR implementation
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. 
13.30 - 15.00



Introduction
13.30 

  
SME office at the EMA
- Helen Casaert - EMA (UK)

13.40

Experience of a Swedish SME
- Asa Holmgren – Medivir (Sweden)

14.10

Panel discussion

14.30 

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