Technical and Regulatory Challenges of Drug Delivery Combination Products - Prefilled Syringes, Autoinjectors and Injection Pens - March
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Registration Options
Individual Registration
Group Registration
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
- Unique In-Vitro and Animal Testing 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.
Agenda
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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
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Venue Details and Accommodations
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 WayOrlando, FL United States
Registration
Pricing Options
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Sponsor information will be available soon
We're currently finalizing our list of sponsors and will share the details shortly.
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:
PDA #464 | ACPE #0116-0000-17-029-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.
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