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2019 BioManu

BioManufacturing

Sep 03 - Sep 04, 2019
Munich, Germany

  • Conference
  • Europe
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Overview

Dear Colleagues,

We are proud to present the inaugural conference 2019 PDA Europe BioManufacturing, 3-4 September 2019 in Munich/Germany.

Over the past 40 years, biopharmaceutical products have become increasingly important medicinal tools for human and animal healthcare. Recognizing the critical role that manufacturing plays in enabling pharmaceutical innovation and the important synergies connecting different product platforms, PDA Europe will be introducing its inaugural Bio-Manufacturing Conference in Munich/Germany. The conference will provide a forum to present innovative approaches and discuss hot topics related to product, process and analytics spanning a variety of biopharmaceutical product classes.

Experts from industry, academia and regulatory agencies are warmly welcomed to attend this unique event and join the exchange and the abundant networking opportunities. On behalf of PDA Europe and the Scientific Program Planning Committee, we look forward to welcoming you to the beautiful city of Munich!

Sincerely,
The Chairs,

Cristiana Campa, PhD,
GSK Vaccines

Michael De Felippis, PhD,
Eli Lilly & Co

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Agenda

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  • Day 1
  • Day 2

  • Tuesday, 3 September 2019

    9:00 – 9:10
    Welcome and Introduction
    Kerstin Wilken, PDA Europe
    Cristiana Campa, GSK Vaccines,Conference Chair
    Michael de Felippis, Eli Lilly, Conference Chair

    Opening Plenary: Updates in Biomanufacturing

    Keynote: Reinventing Biopharma through Digital and Analytics
    Alvaro Carpintero, McKinsey

    Accelerated Access for Biopharmaceuticals
    Mats Welin, Swedish Medical Products Agency

    Coffee Break, Poster Session & Exhibition

    Transition to Two Parallel Tracks

    Session 2A: Accelerated Access

    Session 2B: When Processes Meet Facilities

    Lunch Break, Poster Session & Exhibition

    Transition to Three Parallel Tracks

    Session 3A: ICH Q12 Guideline

    Session 3B: Manufacturing of New Modalitiess

    Session 3C: Interactive Session: How to Design your Ideal Facility

    Coffee Break, Poster Session & Exhibition

    Parallel Tracks

    Session 4A: Continuous Manufacturing and ICH Q13

    Session 4B: Platform Technologies

    Session 4C: Advancements in Test Methods

    18:00
    End of Day 1 and Networking Event

  • Wednesday, 4 September 2019

    Parallel Tracks

    Session 5A: Quality by Design Enabled Control Strategy

    Session 5B: Novel Therapies and Drug Product Design

    Session 5C: IG Meeting Virus Safety and Filtration

    Coffee Break, Poster Session & Exhibition

    Parallel Tracks

    Session 6A: Validation and Analytical Technologies

    Session 6B: Final Formulation and Filling

    Session 6C: Practical Approaches to Contamination Control

    Lunch Break, Poster Session & Exhibition

    Transition to Two Parallel Tracks

    Session 7A: WFI Guideline

    Session 7B: Comparability

    Coffee Break, Poster Session & Exhibition

    Closing Plenary

    Panel Discussion with Regulatory and Industry Experts

    Summary and Conclusions
    Closing Remarks
    End of Conference & Farewell
    Kerstin Wilken, PDA Europe
    Cristiana Campa, GSK Vaccines,Conference Chair
    Michael de Felippis, Eli Lilly, Conference Chair

Additional Information

  • Call for Abstracts

    Call for Papers is available now!

    Download Call for Papers

    Call for Papers/Abstracts is available now.

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    Abstract Submission

    Call for Papers/Abstracts is available now.

    Submit Abstract
  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

  • Accreditation

    Accreditation

    Continuing Education for Pharmacists

    ACPE PDA is accredited by the Accreditation Council for Pharmacy Education (ACPE) as a provider of continuing pharmacy education. Participants may sign up to receive Continuing Pharmacy Education (CPE) credits. To do so, participants must sign in at the beginning of the program, submit the provided evaluation forms and mail the CPE credit request to the address stated on the form. Attendees must be present at the full event to receive Continuing Pharmacy Education credit, which will be awarded as follows:

    ALERT   ACPE and NABP developed the CPE Monitor that allows pharmacists to electronically track their continuing pharmacy education (CPE) credits. The CPE Monitor will reject any CPE credit requests submitted past 60 days from date of ACPE-accredited activity. Always submit CPE activity claims as soon as possible. For more information, please visit the ACPE or NABP website.

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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.

Sheraton Munich Arabellapark Hotel

Arabellastrasse 5
Munich, Germany
Phone: +49 (0)89 92320

Sheraton Munich Arabellapark Hotel
  • Accommodations

    Hotel Website

    The elegant 4-star Sheraton Munich Arabellapark Hotel offers a soundproof accommodation in a residential area of Munich. Featuring chic architecture, the hotel was renovated in 2007. The property is located in Bogenhausen district, 3.5 km from Marienplatz. The city center lies within 4 km from the venue.

    A spectacular view over the countryside welcomes guests to club superior king suite, junior king suite and executive flat with modern-style décor. The property boasts views of Alps from its rooms. Room facilities also include a microwave, an electric kettle and coffee/tea makers for self-catering. The property is in a 5-minute walking distance from Richard-Strauss-Straße subway station. It will take 35 minutes to get to Franz Josef Strauss airport by car.

    PDA Europe has reserved a limited number of rooms until the 15th June 2019.
    Book Your Room for the PDA Group Rate.

    Single Room € 169 per night* 
    Double Room € 194 per night*

    *Rates are per room and night, including the following services and benefits free of charge:

    • Buffet Breakfast in the restaurant
    • Wireless Internet Connection (WI-FI)
    • VAT, Taxes and Service will apply
  • Amenities

How to Get Here

By Air

Nearest Airport: Munich Airport - MUC
Airport Phone: +49 89 975 00

By Car

21.7 mi (35 km), 29 min by car. Sheraton Munich Arabellapark Hotel is located at ArabellaStrasse 5, Munich 81925 Germany.

Other Options

Estimated taxi fare: 55 EUR (one way).

Bus service fee: 10.5 EUR (one way).

Directions

Registration Fees

Early Registration
Registration Type Price by 07 July
Member €1.495
Non-member €1.795
Govern./Health Authority/Academic €750


Regular Registration
Registration Type Price after 07 July
Member €1.695
Non-member €1.995
Govern./Health Authority/Academic €850

All fees given in Euro and excluding VAT

* For this member type or discounted rate, online registration is not available and must be faxed in.

† You must be a member to receive this rate.

All rates in US dollars. To receive the prevailing rate, PDA must receive your registration(s) by 5:00 p.m. ET on or before the date noted.

Group Registration Discount

Register 3 people from the same organization as a group (at the same time) for the Conference or Workshop and receive the 4th registration free. Other discounts cannot be applied.

Special Dietary Requirements

If you require special accommodations and/or have special dietary requirements, please state them in the appropriate field when you register for the event(s).

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 as soon as possible and will receive a full refund. PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees and exhibitors and may be used to follow up on specific areas of interest after the event. Tape recordings are prohibited at all PDA events. For more information, contact registration@pda.org or +1 (301) 656-5900.

SUBSTITUTION: If a substitution request is sent 30 days before the event, no fee will be charged. After this period, a $200 fee will be charged. If you are a non-member substituting for a member, you will be required to pay the difference of the non-member fee.

REFUND: If a refund request is sent 30 days before the event, a full refund will be given minus a $200 fee. After this period, no refunds will be given. Refund requests must either be faxed to + (301) 986-1093 or emailed to registration@pda.org. Phone messages are not accepted.

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