Skip To The Main Content
Parenteral Drug Association Connecting People, Science and Regulation ®

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

May 12 - May 12, 2017 |
May 12, 2017 |
PDA Training and Research Institute | Bethesda, Maryland
  • Education
Add event to: ICal Outlook Google Calendar

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

Standard

Member

On or before March 28, 2017
$1,169

After March 28, 2017
$1,299

Nonmember

On or before March 28, 2017
$1,403

After March 28, 2017
$1,559


Government/Health Authority/Academic

Member

$779

All rates in US Dollars. REFUND FOR COURSES: If your written request is received by April 12, 2017, 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 info@pda.org or +1 (301) 656-5900.

Class Schedule

All courses begin at 8:30 a.m. and end at 4:00 p.m. unless otherwise noted on the confirmation letter or in course information posted on the website or in the course brochures. Courses that are listed with a half day will begin at 8:30 a.m. and end at noon on the last day.

Please arrive at your 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.

A continental breakfast will be served before class beginning 8:00 a.m. Lunch will be provided from 12:00 - 1:00 p.m. Snacks will be provided during the morning break from 10:00 - 10:15 a.m. and the afternoon break from 2:30 - 2:45 p.m.

Location

This course will take place at:

PDA Training and Research Institute
Bethesda Towers
4350 East West Highway, Suite 150
Bethesda, MD 20814 USA

Contact

For more information, please contact:

Stephanie Ko
Senior Manager, Lecture Education
Tel: +1 (301) 656-5900 x151
Email: ko@pda.org

Lee Leichter, President, P/L Biomedical

ACPEPDA 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:

PDA #464 | ACPE #0116-0000-14-029-L04-P | 0.6 CEUs
Type of Activity: Application

Continuing Education for Professional Engineers

New Jersey

PDA is an approved provider by the New Jersey State Board of Professional Engineers and Land Surveyors to offer courses to New Jersey Professional Engineers for Continuing Professional Competency (CPC) credit. Following the full participation in this course, participants will receive a Certificate of Accomplishment specifying the number of CPC credits that may be awarded. This certificate can be submitted as verification of completion to the Board for license renewal.

The credit value of this course is 6 CPC credits.

North Carolina

PDA is recognized by the North Carolina Board of Examiners for Engineers and Surveyors as an Approved Sponsor of Continuing Professional Competency (CPC) activities for Professional Engineers licensed by North Carolina. To receive a Certificate of Accomplishment specifying the number of Professional Development Hours (PDHs) that may be awarded, course participants must request the North Carolina Board of Examiners evaluation form from PDA staff. This form must be completed onsite at the conclusion of the course and returned to PDA staff.

The credit value of this course is 6 PDHs.

Register Now
https://store.pda.org/Meetings/Login.aspx?ID=3570

Directions