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Drug Delivery Combination Products

Apr 14 - Apr 15, 2016
Venice, Italy

This course will be geared towards individuals that have input to; oversight for; or actively participate on; drug delivery combination product development teams.

  • Education
  • Europe
This course will be geared towards individuals that have input to; oversight for; or actively participate on; drug delivery combination product development teams.

Overview

The number and market value of medicinal products that require delivery by a medical device have increased exponentially over the last ten years. These products bring an increased level of complexity to the development and approval process. Also, the way these products are addressed by the regulatory agencies has changed and continues to evolve. This course will contain a combination of presentations, open discussions and hands-on exercises to enhance the knowledge and skills of the attendees.

Who Should Attend

This course will be geared towards individuals that have input to; oversight for; or actively participate on; drug delivery combination product development teams. This includes the following practitioners, managers and directors in medical device, pharmaceutical or consulting companies:

  • Project Management
  • Marketing
  • Regulatory Affairs
  • Quality Assurance
  • Clinical Affairs
  • Human Factors Engineering
  • Device Development Engineering
  • Design Verification Department
  • Packaging Development
  • Testing Laboratories
  • Quality Engineering
  • Manufacturing
  • Formulation

Learning Objectives

Upon completion of this workshop you will be able to:

  • Explain the basic elements and requirements behind the regulation of Drug Delivery combination Products in the USA and EU
  • Plan, propose and choose appropriate regulatory strategies
  • Understand requirements of Design Controls (USA) /Product Realization (EU) including Risk Management, Human Factorsand Clinical Requirements
  • Develop a set of criteria with which to assess, choose and manage Device Partners
  • Develop a set of criteria with which to verify device design, including Functional Requirements
  • Identify the appropriate testing schemes and requirements specific to their products
  • Learn about Post Market Requirements, including Complaints, Reportable Events, Customer Service, Change Management, and Non-conformances including Recalls

Agenda

  • Faculty

    Lee H. Leichter, President, P/L Biomedical
    Mark A. Chipperfield, Principal Consultant, Corvus Device Limited

    Contact

    Elke von LaufenburgElke von Laufenberg 
    Manager Training & Education
    Tel: +49 (0) 30 43 655 08-21
    Fax: +49 (0) 30 43 655 08-66
    Email

Additional Information

  • Learning Objectives

    Learning Objectives

    More information coming soon.

  • Who Should Attend

    Who Should Attend

    More information coming soon.

Got a Question? We have answers

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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.

Hilton Molino Stucky Venice

Giudecca 810
Venice, Italy

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.

Directions

Registration Fees

Regular Price

4 Ways to register

  • Online Registration
  • FAX: +49 30 436 55 08 66
  • Email to Antje Petzholdt
  • Mail: PDA Europe, Am Borsigturm 60, 13507 Berlin, Germany

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).
  • No PDA membership obtainable upon booking training course, workshop or other related event.

Registration Fees

Are you entiteld to receive a discount? Need Help?

All Participants

1,495 Euro

All fees given in Euro and excluding VAT (22%)

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

* For Government/Health Authority/Academic nonmembers, online registration is not available and must be faxed in.

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.

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 [email protected] 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 [email protected]. Phone messages are not accepted.

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Contact

Program Inquiries
Exhibition Inquiries
Training Course Inquiries

Tel: +1 (301) 656-5900
[email protected]

Tel: +49 (0) 30 43 655 08-10

Registration Customer Care

Tel: +1 (301) 656-5900 ext. 115
[email protected]

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