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Biopharmaceuticals, Biosimilars and Advanced Therapies - Development and Regulatory Framework in Europe

Oct 22 2014 8:00AM - Oct 24 2014 5:15PM | Holiday Inn London Kensington Forum 97 Cromwell Road London SW7 4DN United Kingdom

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Overview 

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The scientific basis and data requirements for dossiers at different stages of development will be communicated for the quality, preclinical and clinical parts of regulatory submissions. Case-studies will be inserted for the practical application of knowledge gained.

The training will be delivered as presentations on individual topics, interspersed by case studies and conclude with an outlook on further developments in this fast moving field.

This 3-day training course focuses on drug development of biopharmaceuticals which have become the focus of pharmaceutical innovation and currently represent 30% to 50% of newly authorised medicinal products.

Participants will learn about the legislative and regulatory framework for biopharmaceuticals in Europe and the roles of the European Medicines Agency and National Competent Authorities in market access. This covers the clinical trial stage, licensing and the life-cycle of these products. Specific development paths will be delineated, such as those for biosimilars and ATMPs, the latter comprising somatic cell therapies, gene therapies and tissue engineered products.

To see the detailed programme, please click on View PDF above.

What You Will Learn 

  • Regulatory pathways for scientific advice, clinical trials and marketing authorisations of biopharmaceuticals
  • Definition and characteristics of biopharmaceuticals
  • Modules 3, 4 and 5 of the EU Common Technical Document (CTD) of biopharmaceuticals
  • Biosimilar medicinal products
  • Topics of particular relevance to biopharmaceuticals such as comparability, immunogenicity, adventitious safety, bioassays, combination products
  • ATMPs
  • Topics of particular relevance to biopharmaceuticals such as comparability, immunogenicity, bioassays, adventitious agents, quality by design, combination products

Who Should Attend 

  • Regulatory affairs and clinical research professionals who wish to learn about biopharmaceuticals or update their knowledge
  • Early stage drug developers who need to chart their path for development
  • Practising physicians and pharmacists wanting to understand how these innovative products reach the market

 Course level: junior to intermediate

Learning Objectives 

At the conclusion of this training course, participants should be able to:

  • Identify the relevant stakeholders and pathways of the EU regulatory framework
  • Understand the necessary steps and unique requirements in biopharmaceutical development
  • Identify the key quality issues specific to biopharmaceuticals, including implications of changes in the manufacturing process
  • Identify the required documentation for the non-clinical part of dossiers
  • Know the clinical dossier aspects and considerations
  • Understand the concept and peculiarities of the biosimilar path in the EU and beyond
  • Classify ATMPs and understand the specific provisions and requirement for this class of products
  • Have an awareness of common flaws in regulatory submissions and be able to apply best practices for regulatory submissions
  • Have an outlook on future regulatory developments in Europe

 

Participants will complete a knowledge check at the end of the course and will be provided with feedback to ensure learning objectives are attained.

Hotel & Travel 

This course will take place at:

Holiday Inn London Kensington Forum

97 Cromwell Road

London, SW7 4DN

Tel: +44 207 341 33 55

www.hikensingtonforumhotel.co.uk

 

Limited number of hotel rooms are reserved for DIA training course attendees at the rate of GBP 165.00 per single room including Full English Breakfast and VAT. In order to book a hotel room please call the number above and quote the reference "ZS2". The rate is available until 22 September 2014 or until the room block is sold-out, whichever comes first.

 

HOW TO GET THERE

From Heathrow Airport take the Piccadilly Line to Gloucester Road station. Travel time 30 min, GBP 14.00 single ticket.

Contact Information 

DIA Europe, Middle East and Africa
Kuechengasse 16
4051 Basel, Switzerland

Registration questions
Contact Center
Tel: +41 61 225 51 51
diaeurope@diaeurope.org

Programme details
Ms Gunta Sveke
Tel: +41 61 225 51 55
gunta.sveke@diaeurope.org

Faculty 

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Agenda  

Day 1 Wednesday, Oct 22, 2014

  • 8:00AM - 8:30AM (GMT Standard Time)

    REGISTRATION
  • 8:30AM - 8:45AM (GMT Standard Time)

    WELCOME AND INTRODUCTION
  • 8:45AM - 10:30AM (GMT Standard Time)

    Session 1: REGULATORY PATHWAYS FOR CLINICAL TRIALS, LEGAL ASPECTS, SCIENTIFIC ADVICE AND MARKETING AUTHORISATION OF BIOPHARMACEUTICALS IN THE EU
  • 10:30AM - 11:00AM (GMT Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:30PM (GMT Standard Time)

    Session 2: DEFINITION AND CHARACTERISTICS OF BIOPHARMACEUTICALS
  • 12:30PM - 1:30PM (GMT Standard Time)

    LUNCH
  • 1:30PM - 3:30PM (GMT Standard Time)

    Session 3: THE QUALITY REQUIREMENTS FOR BIOPHARMACEUTICALS
  • 1:30PM - 3:30PM (GMT Standard Time)

    Session 8: THE CLINICAL DEVELOPMENT OF BIOPHARMACEUTICALS
  • 3:30PM - 4:00PM (GMT Standard Time)

    COFFEE BREAK
  • 4:00PM - 5:00PM (GMT Standard Time)

    Session 4: GROUP DISCUSSION ON TYPICAL CMC ISSUES
  • 5:00PM - 5:30PM (GMT Standard Time)

    Session 5: ADVENTITIOUS AGENTS’ SAFETY EVALUATION AND EDQM TSE-RELATED CERTIFICATION
  • 5:30PM - 6:00PM (GMT Standard Time)

    QUESTIONS AND ANSWERS
  • 6:00PM - 7:00PM (GMT Standard Time)

    DRINKS RECEPTION

Day 2 Thursday, Oct 23, 2014

  • 8:30AM - 10:30AM (GMT Standard Time)

    Session 6: THE NON-CLINICAL DEVELOPMENT PROGRAMME FOR RECOMBINANT PROTEINS
  • 10:30AM - 11:00AM (GMT Standard Time)

    COFFEE BREAK
  • 11:00AM - 12:30PM (GMT Standard Time)

    Session 7: GROUP WORK: A CASE STUDY ON A NON-CLINICAL PROGRAMME OF A CHALLENGING MOLECULE
  • 12:30PM - 1:30PM (GMT Standard Time)

    LUNCH
  • 3:30PM - 4:00PM (GMT Standard Time)

    COFFEE BREAK
  • 4:00PM - 5:00PM (GMT Standard Time)

    Session 9: GROUP WORK: CASE STUDY OF MONOCLONAL ANTIBODIES ILLUSTRATING HOW THE BENEFIT/RISK RATIO IS DETERMINED
  • 5:00PM - 6:00PM (GMT Standard Time)

    Session 10: THE COMPARABILITY EXERCISE FOR MANUFACTURING PROCESS CHANGES

Day 3 Friday, Oct 24, 2014

  • 8:30AM - 10:30AM (GMT Standard Time)

    Session 11: REGULATORY PRINCIPLES OF DEVELOPMENT OF BIOSIMILAR MEDICINAL PRODUCTS
  • 10:30AM - 11:00AM (GMT Standard Time)

    COFFEE BREAK
  • 11:00AM - 1:00PM (GMT Standard Time)

    Session 12: REGULATORY PRINCIPLES RELEVANT FOR ATMPS AND CURRENT EXPERIENCE WITH MARKETING AUTHORISATION APPLICATIONS AND CLINICAL TRIAL APPLICATIONS
  • 1:00PM - 2:00PM (GMT Standard Time)

    LUNCH
  • 2:00PM - 2:30PM (GMT Standard Time)

    QUESTIONS AND ANSWERS
  • 2:30PM - 3:15PM (GMT Standard Time)

    COURSE ASSESSMENT
  • 3:15PM - 3:45PM (GMT Standard Time)

    COFFEE BREAK
  • 3:45PM - 5:15PM (GMT Standard Time)

    Session 13: OUTLOOK

Registration Fees 

Member

Charitable Nonprofit/Academia Member
€920.00
Member Government
€920.00
Member Standard
€1840.00

Non-Member

Charitable Nonprofit/Academia Nonmember
€1050.00
NonMember Government
€1050.00
NonMember Standard
€1970.00
Register Online

CANCELLATION POLICY: All cancellations must be made in writing and received at the DIA office five working days prior to the event start date. Full event cancellations are subject to an administrative fee:

  • Industry (Member/Non-member) = €200.00
  • Academia/Charitable/Government /Non-profit (Full-Time) (Member/Non-member) = €100.00
  • Tutorial cancellation: €50.00

If you do not cancel five working days prior to the event start date and do not attend, you will be responsible for the full registration fee. DIA reserves the right to alter the venue and dates if necessary. If an event is cancelled DIA is not responsible for airfare, hotel or other costs incurred by registered attendees. Registered attendees are responsible for cancelling their own hotel and travel reservations.

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