Innovative Drug Delivery Systems/Combination Products Workshop

Oct 21, 2019

Gothenburg, Sweden

Risk Management and the New European Medical Devices Regulation

Workshop

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Overview
Agenda
Additional Information
Travel
Registration Fees
Exhibit & Sponsorship
Contact

Program Highlights

PDA is planning a series of workshops as a kick-off to the Universe of Pre-filled Syringes Meeting. The workshop topics are soon to be published – check the website regularly or to send us an email we will inform you when these go online.

Overview

The Workshop will focus on Risk Management and the New European Medical Devices Regulation and the challenges associated with the practical implementations.

Learn from suppliers’ latest solutions and hear guest speakers and industry experts share an outlook on what to expect with the implementation of the new EMDR and specific requirements for combination products. Interact with other participants and speakers during round table discussions and exchange on all issues vital for the success of your product. Interactive Group exercises will ensure conclusive and practical take-home-messages for the participants.

Agenda

Monday, 21 October 2019

10:00 – 17:00

Welcome & Introduction
Falk Klar, PDA Europe
Thomas Schoenknecht, Lonza

Latest Trends in Device Commercialization
Thomas Schoenknecht Lonza
- Inhalation products
- Patch infusers/Large volume injections
- Adherence Systems/Technologies
Risk Management for Combination Products - Specific Requirements for Combination Products
Alphons Fakler, Novartis

11:10
Coffee Break & Exhibition

Risk Management
Moderator: Alphons Fakler, Novartis
- Core principles in risk management: Severity, Occurrence, Harm and Hazard
- Typical hazards with injection devices
- Definition of occurrence of harm
Round Table Discussion

13:00
Lunch & Exhibition

European New Medical Devices Regulation
Moderator: Mike Wallensteinr, Novartis
An Introduction to the European New Medical Devices Regulation and the Consequences for Combination Products
- General Overview and Timelines
- MDR product related aspects
- MDR system related aspects
- Identification of products
Round Table Discussion
- Single Integral Drug Device Combinations under Article 117
- Co-Packed Drug Device Combinations
15:30
Coffee Break & Exhibition

Closing
Moderator: Thomas Schoenknecht, Lonza
Summary of Roundtable Discussions

Supplier presentations
- Interactions with customers
- Tech Transfer
- Case Studies
- Latest trends in specialized devices
17:00
End of Workshop & Farewell
Thomas Schoenknecht, Lonza
Falk Klar, PDA Europe

Additional Information

Learning Objectives
Learning Objectives

Upon participation of this workshop you will be able to:
- Learn about the latest trends in commercialization of different devices such as inhalation products, patch
- Understand the specific requirements for clinical trials, surveillance and classification of devices under the New European Medical Devices Regulation
- Understand the core principles and requirements for risk management of combination products
Who Should Attend

Who Should Attend

The target audience for this workshop is from departments like Device Development, Compliance, Operations, Regulatory Affairs, Manufacturing, Pharmaceutical Formulation and Process Development, Business Development, Marketing, Procurement, CMC, Distribution, Packaging, Quality Assurance/Control, Clinical Affairs.
Accreditation

Accreditation

Continuing Education for Pharmacists

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.

Got a Question? We have answers

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.

The Swedish Exhibition & Congress Centre Gothia Towers Hotel

Mässans Gata 24
Gothenburg, Sweden

Make a Reservation

Accommodations

The Swedish Exhibition & Congress Centre Gothia Towers Hotel
Mässans Gata 24
41294 Gothenburg, Sweden

Hotel Accommodation

optiMICE is the official housing provider for The Universe of Pre-filled Syringes and Injection Devices 2019. We recognize that attendees have many options with area hotels, and that you may be looking only at the per night cost in making your decision. However, we encourage you to understand the importance and recognize the benefits of selecting an official PDA Europe hotel.
You can book your Hotel Accomodation here!
Amenities

How to Get Here

By Air

Nearest Airport: Gothenburg-Landvetter Airport – GOT
Airport Phone: +46 10 109 31 00

By Car

22.9 km, 20 min by car. Gothia Towers is located at Mässans gata 24, Göteborg.

E6/E20 (from the north) and road 45 (from Karlstad): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the first exit on the left, then turn right on to Örgrytevägen and then take the next right exit for the hotel.

E6/E20 (from the south) and road 40 (from Borås): On arriving in Gothenburg, turn off when you see the sign for Mässan Scandinavium Liseberg. Take the second exit on the right for the hotel.

Other Options

Flygbussarna airport coach: to Korsvägen/the Swedish Exhibition & Congress Centre, opposite the hotel.

Public transportation: Korsvägen stop, 100 meters from hotel.

Directions

Registration Fees

Regular Price

Registration Type	Price
All Participants	€795

All fees given in Euro and excluding VAT (25%)

* 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.

All prices in Euro (EUR)

For your credit card information safety: Please send your details by fax only

For an easier registration, please note the helpful hints on the registration form

Ways to Register

Online Registration
FAX: +49 30 436 55 08 66
registration-europe@pda.org

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).
Please contact us if you are entiteld to receive a discount

Antje Petzholdt

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

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Contact

Program Inquiries

Teresa Schubach
Manager, Programs & Events

schubach@pda.org

Exhibition Inquiries

Nadjeschda Gomez-Stahl
Manager, Exhibition & Sponsorship

gomez@pda.org

Training Course Inquiries

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
registration@pda.org

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Innovative Drug Delivery Systems/Combination Products Workshop

Registration Options

Individual Registration

Group Registration