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
- Regulatory Affairs
- Quality Assurance
- Clinical Affairs
- Human Factors Engineering
- Device Development Engineering
- Design Verification Department
- Packaging Development
- Testing Laboratories
- Quality Engineering
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
More information coming soon.
ALL PRICES IN EURO (EUR), EXCLUDING VAT.
WAYS TO REGISTER: 1. Online Registration 2. [email protected]
PDA MEMBERS: Please remember to log in before registering If you come from a Governmental or Health Authority Institution or from an Academic Organization, please contact [email protected] before registering.
If you need to apply for a visa to enter the event country, PDA Europe must be informed of this fact at least 4 weeks before the start of the event.
Lee H. Leichter, President, P/L Biomedical
Mark A. Chipperfield, Principal Consultant, Corvus Device Limited
ContactElke von Laufenberg
Manager Training & Education
Tel: +49 (0) 30 43 655 08-21
Fax: +49 (0) 30 43 655 08-66
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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 VeniceGiudecca 810
Venice, Italy , Italy
Hilton Molino Stucky Venice
TEL: +39-041-272 3311
FAX: +39-041-272 3490
Hilton Molino Stucky Venice
Once a flourishing flourmill, Hilton Molino Stucky Venice has been beautifully restored and offers a different view of the magical city of Venice.
Explore Venice from the Hilton Molino Stucky Venice hotel, a historical, neo-gothic building on Guidecca Island, once home to a grand flour mill in 1895. Visit Venice attractions, just a few minutes from the hotel via shuttle boat service to St. Mark's Square.
Revive in a comfortable guest room featuring timber beam ceilings, a marble bathroom and plush Venetian fabrics. Choose an Executive Room, and enjoy access to the Executive Lounge, serving complimentary drinks and snacks all day. Relax in an Executive Suite or in a Tower Suite with a spacious, separate living area.
Hilton Molino Stucky Venice has been nominated World's Leading Conference Hotel 2015 by World Travel Awards. The hotel won the titles of Europe's and Italy's Leading Conference Hotel 2013, 2014 and 2015. Boasting Venice's largest congress center the hotel's ballroom has space for 1,000 guests.
Indulge in delicious cuisine at one of seven bars and restaurants. Savor fresh, seasonal ingredients at this Venice hotel's signature restaurant, Aromi, and enjoy alfresco dining on the terrace beside the canal. Sip fine wine, and admire Venice’s spectacular sweeping vistas at the stylish Skyline Rooftop Bar.
Plunge into the rooftop pool, open seasonally from mid May to September, and take in beautiful views of Venice. Work out in the 24-hour fitness center, complete with the latest exercise equipment. Indulge in spa treatments in the hotel's wellness center, or bathe in the Turkish bath.
PDA Europe had reserved a limited number of bedrooms. Unfortunately all rooms at the PDA group rate are sold.
If you want to make your booking, please use this link.
How to get there
Airport Marco Polo Venice (Marco Polo-Tessera)
You can reach Piazzale Roma (bus station) with the public bus line n.5, then take "vaporetto" water public bus line 2 or 4.1 direction Giudecca-San Marco to reach the hotel.
The stop is Palanca and after 5 mins walk you are at the hotel.
Distance from Hotel: 10 km
Drive Time: 40 min
Typical Minimum Charge
Public: Waterbus Service 13.00 EUR
Private: Watertaxi 100.00 EUR
Take public bus to Piazzale Roma (bus station), then board the water public bus 2 or 4.1 to Giudecca-San Marco (stop "Palanca" and walk 5 mins to hotel). If you have luggage, stop at Zattere and take shuttle boat that stops at the hotel.
Distance from Hotel: 60 km.
Drive Time: 90 min.
Typical Minimum Charge
Bus Service 15.00 EUR
Super Shuttle 3.5 EUR p/person p/stay
Self parking: Not Available
Valet: Not Available