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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Parallel sessions are open to all Symposium attendees.

TUESDAY, 2 OCTOBER

Chemistry Manufacturing and Controls (CMC) 

This session is in two parts:

  • Part 1 will focus on the challenging aspects facting CMC in the area of paediatric medicines/age appropriate formulations that permit accurate dosing and enhance adherence, and are an important part of any paediatric regulatory programme. A global strategy for development and filing age-appropriate paediatric information is a key component of the regulatory strategy.
  • Part 2 will examine the evolving regulatory reforms in China and the potential for impact to CMC strategies throughout the product lifecycle. 

Leader: Sarah Fitzgerald – Director, Alexion

11.00  Introduction 
11.05 

Paediatric formulations – Global CMC considerations and challenges 

  • Development of paediatric formulations with a focus on CMC strategy
  • Regulatory hurdles encountered with paediatric filings 

Q&A/panel discussion

Speaker: Cheryl English – Director, Global CMC, Pfizer

11.45 

China an evolving regulatory landscape – CMC considerations

  • Regulatory process and evolving environment in China
  • Challenges/opportunities for CMC
  • Q & A/panel discussion moderated by chair with today’s speakers plus invited guests
Speaker: Karen Davis – Regulatory CMC Associate Director, AstraZeneca
12.30  Break 



Enhancing Product Information and the Opportunity to Develop an Electronic Approach
In the Pharmacovigilance Directive 2010/84/EC, Article 59, the European Commission was required to present to the European Parliament and the Council an assessment report on current shortcomings in the summary of product characteristics (SmPC) and the package leaflet (PL) and how they could be improved in order to better meet the needs of patients and healthcare professionals. In March 2017 the European Commission released the final assessment report including areas to be improved within current legislation and in November 2018 the EMA issued their Action Plan in response to the report including a key proposal to have a multistakeholder workshop in Q3 2018 to develop principles for the development of electronic provision of product information. This session will provide an opportunity to discuss the recommendations made in the report and how best they can be implemented, particularly with regard to the development of an electronic approach to enhance the patient’s understanding of their medicine and have rapid access to up to date information. 

Leader and Chair: Isabella Sanderfelt – Head of Regulatory Affairs, Nordic and Baltic Region, Pfizer, Sweden 
14.00  Introduction 
14.05 

Recommendations of the European Commission report and summary of the EMA Action Plan

  • Summary of key recommendations
  • Proposed Action Plan activities and timelines
  • EMA/EC views on an electronic approach and anticipation of the EMA workshop
Speaker: Fabio D'Atri – Policy Officer, Unit B4, DG SANTE, European Commission

14.35 

Industry perspectives on the Commission report and views on an electronic approach

  • Industry views on improvements to product information
  • Technical considerations on the development of an electronic approach
  • Overview of industry activities to date
Speaker: Sharon Gorman – Director, EU Regulatory Policy, Pfizer Ltd, UK 

14.50 

A national perspective from Sweden and the Nordic countries

  • Current status and initiatives in Sweden and the Nordic countries
Speaker: Christer Olsson – Head of Regulatory Affairs, Nordics and Baltics, Sanofi. Participant in LIF's e-PIL Group
   
15.05  Panel discussion  
15.30  Break


WEDNESDAY, 3 OCTOBER

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. 

Leader and Chair: Jayne Hunt – Associate Director, Boyd Consultants (Boyds) Ltd, UK
 9.15 Introduction
9.20

Main topic presentation 

Part 1: Legal definition

  • Differentiation between a biologic and an ATMP
  • Overview of the regulations and directives
  • The role of the Committee for Advanced Therapies (CAT)

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

Part 3: Examples 
Cell based inc 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 – Associate Director, Boyd Consultants (Boyds), UK

10.15 Panel Q&A session
Session speakers plus guest panellist Hélène Casaert – Scientific Administrator, Corporate Stakeholders - SME Office, European Medicines Agency

10.45  Break 



Clinical Trials Regulation
The implementation date for the EU clinical trial portal is now expected in 2020. After a transitional period of one year it will be mandatory to use the portal and database for all new clinical trials in the EU, and after three 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.  

Leader and Chair: Susan Bhatti – Director, EU Global Regulatory and Scientific Policy, Merck KGaA, Germany
11.15  Introduction 
11.20 

Clinical Trials 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, Global Regulatory Affairs Oncology, Merck KGaA
11.40 

CTR pilot and CTR implementation in Sweden from the Health Agency perspective

  • Update from Health Authority perspective on the CT portal and agency readiness
  • Provide insights on MPA's CRT joint pilot project
Speaker: Gunilla Andrew-Nielsen – Head of Clinical Trials, Swedish Medical Products Agency
12.00 

CTR pilot and CTR implementation in Sweden from EC perspective

  •  Update from a national EC perspective on CT portal and EC readiness for implementation
  • Provide insights from an EC perspective on Sweden's joint pilot CTR project
Speaker: Johan Modin – Swedish Medical Products Agency
12.20  Panel discussion 
12.45  Break 


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