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Vaccines

Apr 24 - Apr 25, 2018
Malaga, Spain

  • Conference
  • Europe
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Program Highlights

Regulatory Speakers Confirmed!

  • Mats Welin
    Medical Products Agency, Sweden
  • Heidi Meyer, PhD
    Paul-Ehrlich-Institut
  • Gwenaël Ciréfice, PhD
    European Directorate for the Quality of Medicines & HealthCare, EDQM
  • Richard H. Siggers, PhD
    Biologics and Genetic Therapies Directorate, Health Canada
  • Erika Pfeiler, PhD
    CDER Division of Microbiology Assessment, US FDA
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Overview

Dear Colleagues,

We are delighted to invite you to the 2018 PDA Europe Vaccines conference to be held 24-25 April 2018.

The conference will address new trends in vaccine development and life cycle management, including (1) use of platform technologies, (2) prior knowledge, (3) development of novel vaccines comprising therapeutic vaccines and cancer vaccines, and (4) considerations on accelerated development scenarios. In this context, Quality by Design principles have now been embedded in various aspects of vaccine development and beyond. The conference will provide an overview of the applicability of QbD in various aspects, from product, analytics and process standpoint and considerations during life cycle management, as well as touch base on newer trends in the regulatory field such as ICHQ12.

We aim to continue the discussion around current CMC trends and regulatory strategies for emerging diseases, as started in frame of the Ebola vaccine some years ago and which has evolved since then.

We look forward to welcoming you to this special PDA Europe event in Spain next April!

Sincerely, The Chairs

Cristiana Campa, Conference Chair, GSK Vaccines
Nancy Cauwenberghs, Conference Chair, MSD

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Agenda

  • Tuesday, 24 April 2018

    9:00
    Welcome and Introduction
    Kerstin Wilken, PDA Europe
    Cristiana Campa, Conference Chair, GSK Vaccines
    Nancy Cauwenberghs,Conference Chair, MSD

    9:10 - 11:15
    Session 1: Regulatory Updates
    Moderator: Thierry Gastineau, Sanofi

    9:10
    Regulatory Convergence for Vaccines & Post Approval Changes
    Heidi Meyer, Paul-Ehrlich-Institut

    09:40
    Harmonized Approaches for Vaccine Lifecycle Management
    Richard H. Siggers, Biologics and Genetic Therapies Directorate, Health Canada

    10:10
    Human Vaccines in the European Pharmacopoeia: Latest Developments
    Gwenaël Ciréfice, European Directorate for the Quality of Medicines & HealthCare, EDQM

    10:40
    Q&A, Discussion

    11:15 – 11:45
    Coffee Break, Poster Session & Exhibition

    11:45 - 13:30
    Session 2: Platform Technologies & New Products
    Moderator: Kerstin Wilken, PDA Europe

    11:45
    A New TB Vaccine on the Horizon
    Leander Grode, VPM

    12:10
    Next Generation of Glycan-based Vaccines
    Arne v. Bonin, Vaxxilion

    12:35
    Use of Platform and Prior Knowledge to Advance Development of Adenoviral Vector-based Vaccines
    Els van Deventer-Troost, Janssen J&J

    13:00
    Development and Optimization of Viral Platform Manufacturing Processes for Cost Effective and Faster Release of Vaccines
    Anissa Boumlic, Merck KGaA

    13:30 – 14:30
    Lunch Break, Poster Session & Exhibition

    14:30 – 16:30
    Session 3: Accelerated Development and Prior Knowledge
    Moderator: Nancy Cauwenberghs, MSD

    14:30
    Prior Knowledge - Considerations for Vaccines
    Mats Welin, MPA

    15:00
    Acceleration Strategies for Fast Access of Vaccines to Patients
    Amin Khan, GSK Vaccines

    15:30
    A Vaccine for Ebola Virus - A Case Study on Approaches to Accelerate Process Development and Characterization Studies
    Joseph P. Califano, MSD

    16:00
    Q&A, Discussion

    16:30 – 17:00
    Coffee Break, Poster Session & Exhibition

    17:00 – 18:30
    Session 4: Risk-based Approaches to Analytical Development and Facility Design for Vaccines
    Moderator: Annick Vandercammen, GSK Vaccines

    17:00
    Application of the QbD Mindset to the Analytical Strategy - The Key to Success
    Thomas Jacques, GSK Vaccines

    17:30
    Challenges and Opportunities of QbD Integration in Vaccine Development and Manufacturing
    Nausheen Rahman, Sanofi Pasteur

    18:00
    Risk-Based Biopharmaceutical Facility Design Approaches
    Kavita Ramalingam Iyer, MSD

    18:30
    End of Conference Day 1

    19:30
    Networking Reception

    Wednesday, 25 April 2018

    9:00
    Welcome and Introduction
    Kerstin Wilken, PDA Europe
    Cristiana Campa, Conference Chair, GSK Vaccines
    Nancy Cauwenberghs,Conference Chair, MSD

    9:05 - 11:05 
    Session 5: Evolving Technical Considerations for Vaccine Manufacturing
    Moderator: Cristiana Campa, GSK Vaccines

    9:05
    Predicting Pyrogenic Content without Animal Models
    Sara Valentini, GSK

    9:35
    The Challenge of Process Parameters Categorization: A Comprehensive Ranking Process
    Geoffroy Geldhof, GSK Vaccines

    10:05
    Process Validation and Continuous Process Verification of the Sterilization Process of Vaccines
    Anton Mangold, tempris
    Alexandre Cassis, GSK Canada

    10:35
    Pre-fillable Syringe Selection Criteria for Vaccines: Technical Comparison of Several Syringe Types
    Laurent Jeanmart, GSK Vaccines
    Christian Helbig, SCHOTT

    11:05 – 11:35
    Coffee Break, Poster Session & Exhibition

    11:35 – 13:15
    Session 6: Innovative Downstream Processing for Vaccines
    Moderator: Martha Folmsbee, PALL

    11:40
    Filtering Confusion from the Review Process: Current Topics in Sterilizing Filtration at FDA/CDER
    Erika Pfeiler, US FDA

    12:05
    Understanding the Sterile Filtration of Vaccine Nanosuspensions
    John Welsh, PALL

    12:35
    Filter-based Clarification of Viral Vaccines & Vectors
    Youness Cherradi, Merck KGaA

    13:00
    Q&A, Discussion

    13:15 – 14:15
    Lunch Break, Poster Session & Exhibition

    14:15 – 17:00
    Session 7: Global Industry Perspectives on Current Regulation - Future Outlook
    Moderator: Nancy Cauwenberghs, MSD

    14:15
    The Complexity of Post-Approval Change Management and New Regulatory Approaches: Relevance for Vaccine Products
    Andrew Deavin, GSK Vaccines
    Thierry Gastineau, Sanofi Pasteur

    14:45
    Vaccine Shortage - From Words to Action Vaccines Heads of Quality Perspective
    Anders Vinther, Sanofi Pasteur
    Marcello Colao, GSK Vaccines

    15:15 – 15:45
    Coffee Break, Poster Session & Exhibition

    15:45
    Panel Discussion, Q & A - Conference Highlights: Opportunities for Vaccine Development
    Mats Welin, MPA
    Heidi Meyer, PEI
    Richard H. Siggers, Health Canada
    Gwenaël Ciréfice, EDQM

    16:30
    Summary & End of Conference & Farewell
    Cristiana Campa, Conference Chair, GSK Vaccines
    Nancy Cauwenberghs, Conference Chair, MSD
    Kerstin Wilken, PDA Europe

Additional Information

  • Who Should Attend

    More information coming soon.

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Travel

PLEASE READ  PDA is not affiliated or contracted with any outside hotel contracting company. If someone other than PDA or the PDA chosen hotel contacts you suggesting that they represent any PDA event, they do not. It is PDA's recommendation that you book your hotel directly through the official PDA chosen hotel that is listed on our web site.

Meliá Costa del Sol

Paseo Marítimo 11
Malaga, Spain

Exterior

Melia COSTA DEL SOL
Paseo Marítimo, 11
29620 Torremolinos
Malaga
Spain
Tel: (34)952386677
Fax: (34)952386417
Hotel Website

Located in Malaga, in the resort of Torremolinos, in the heart of the Costa del Sol, and strategically located right on the beach, Meliá Costa del Sol is the best option for unwinding, having fun and working in Malaga, thanks to its excellent location, its complete and comfortable facilities and its superb service

Modern rooms are bright and spacious. They have a terrace overlooking the Mediterranean Sea. All are air conditioned and have a safe, flat-screen satellite TV and well-equipped bathroom. Meliá Costa del Sol offers a buffet and continental breakfast, as well as Mediterranean cuisine for dinner. À la carte options are also available, and there is live music in Bar Barlovento.

PDA Europe has reserved only a limited number of rooms, please make sure to book your room for the PDA Group Rate

Single Room € 99 per night*
Double Room upon request*

*Rates are per room and night, including the following services and benefits:
  • Buffet Breakfast in the restaurant
  • Wireless Internet Connection (WI-FI) 
  • 10% VAT, Taxes and Service Charge will apply

How to Get There

Malaga Airport – AGP
Airport Phone: +34 902 40 47 04
Hotel direction: 8,1km

Parking

  • Private parking: (reservation is needed)
  • 20 Euros per day

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How to Get Here

By Air

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Directions

Registration Fees

Regular Price

3 Ways to register

Please remember to log in if you are a member of PDA already!

If you come from a Governmental or Health Authority Institution or from an Academic Organization please contact Ms. Antje Petzholdt before registering. She will verify your status and register you.

  • All registrations which will involve visa matters will have to be submitted to PDA EU four weeks prior to the start of the event at the latest. For later registrations, PDA Europe will be unable to assist participants in any visa affairs.
  • All costs incurring in connection with visa affairs shall be borne by registrants. (This applies in particular to costs for submitting documents by courier.)
  • Potential participants must be clients of UPS shipping agency and submit their UPS customer reference number to PDA EU (together with their registration).

Registration Fees

Are you entiteld to receive a discount? Need Help?

Member

By 4 March 2018
1.395 Euro

After 4 March 2018
1.595 Euro

Nonmember

By 4 March 2018
1.695 Euro

After 4 March 2018
1.895 Euro

Govern./Health Authority/Academic

By 4 March 2018
700 Euro

After 4 March 2018
800 Euro

All fees given in Euro and excluding VAT (21%)

Contact

Antje PetzholdtAntje Petzholdt
Manager Registration, Chapters & Membership
Tel: +49 (0) 30 43 655 08-10
Fax: +49 (0) 30 43 655 08-66
Email

Group Registration Discount: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.

GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.

CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].

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Tel: +1 (301) 656-5900
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Tel: +49 (0) 30 43 655 08-10
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