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Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens - March

Mar 22, 2018
Orlando, FL

The course will examine the technical and regulatory challenges companies will face in the development and registration of drug delivery combination products.

  • Education

Duration: 1 day
Time: 8:30 a.m. - 4:00 p.m.


The course will examine the technical and regulatory challenges companies will face in the development and registration of drug delivery combination products.  The course will cover:

  • Applicable Regulatory Schemes in the US and EU and Potential Regulatory Strategies
    • Brief History and Basics of Regulatory Definitions
    • Application of Regulations and Directives to Drug Delivery
    • Differences in USA and EU Requirements
    • Regulatory Strategies
  • Partner (Vendor) Selection and Oversight
    • Product Criteria
    • Partner Criteria
    • RFP Process
  • Impact and Expectations for GMP/QSR Compliance
    • US GMPs
    • Key Quality Systems Expectations During Design
    • EU Requirements
    • Leveraging Partner's Systems
  • Technical Requirements - Creation of a Design History File
    • Unique In-Vitro and Animal Testing Requirements
      • Performance/Functional Requirements
      • Material Requirements
      • Stability Expectations
    • Risk Management and Human Factors Requirements and Expectations
      • Risk Management Requirements
      • Usability Requirements
  • Current Clinical Requirements, Expectations and Challenges
    • Current Clinical Expectations And Strategies For Clinical Bridging
  • Format, Elements and Data Requirements for Marketing Authorization Submissions

Upon returning to your company, participants will be able to initiate a gap analysis to identify the requirements and elements of a successful drug delivery combination product development program.  Proper implementation of these elements will minimize project risk.

Who Should Attend

This course will be geared towards individuals who have oversight for or actively participate on drug delivery combination product development teams. This includes project managers as well as directors or managers in marketing, regulatory affairs, quality assurance, clinical affairs and device development engineering.


  • Upon completion of this course, you will be able to:

    • Discuss the basic elements and requirements behind the regulation of drug delivery combination products
    • Propose and choose appropriate regulatory strategies
    • Develop a set of criteria with which to assess and choose device partners
    • Explain the GMP/QSR expectations and responsibilities relevant to companies developing and manufacturing these products
    • Describe the expectations for robust risk management and human factors engineering systems in order to execute a successful development program
    • Identify the appropriate testing schemes and requirements specific to your products
    • Outline the contents of a clinical or marketing approval application

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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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.

Loews Sapphire Falls

6601 Adventure Way
Orlando, FL

How to Get Here

By Air

More information coming soon.

By Car

More information coming soon.

Other Options

More information coming soon.


Registration Fees

Regular Price



On or before February 5, 2018

After February 5, 2018


On or before February 5, 2018

After February 5, 2018

Government/Health Authority/Academic



All rates in US Dollars. REFUND FOR COURSES: If your written request is received by February 20, 2018, you will receive a full refund less a $200 processing fee. After that time, no refunds will be approved. COURSE CANCELLATION: PDA reserves the right to modify the material or instructors without notice, or to cancel an event. If an event must be cancelled, registrants will be notified by PDA as soon as possible and will receive a full refund. PDA will not be responsible for airfare penalties or other costs incurred due to cancellation. For more details, contact PDA at [email protected] or +1 (301) 656-5900.

General Course Information

Please arrive at the course location approximately thirty minutes before the start of the course to sign in. Please be sure to bring your confirmation letter as proof of registration. PDA will not allow persons to attend a course without payment, or guarantee of payment.

Breakfast will be served thirty minutes before the class begins. Lunch will be provided between 12:00 - 1:00 p.m.


This course will take place at:

Loews Sapphire Falls Resort
6601 Adventure Way
Orlando, FL 32819
Phone: +1 (407) 503-5000


For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: [email protected]

* 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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