Skip To The Main Content

PDA Metro Chapter Dinner: Risk Assessment & Management of Combination Product

Mar 25, 2020
Bridgewater, NJ

  • Chapter
Cancelled

Overview

PDA METRO CHAPTER STATEMENT  AMID COVID-19 CONCERNS & EVENT CANCELLATION NOTICE

The health and well-being of our members and delegates are top priorities for PDA Metro Chapter.

We are monitoring the Corona virus (COVID-19) situation closely, as  well as following the advice issued by the CDC and the WHO.

Due to numerous travel restrictions, growing concern, and an exercise in caution we have cancelled the Risk Assessment Dinner scheduled for March 25th.

Join the PDA Metro Chapter in an evening talk with Jon Cammack, who will highlight considerations in implementing a risk management process for combination products.

About this Event

Our evening's discussion will highlight considerations in implementing a risk management process for combination products.

The U.S. Food and Drug Administration (the FDA) terms therapeutic and diagnostic medical products that combine drugs, devices, and/or biological products with one another as combination products. Risk management, the iterative process of analyzing, evaluating, controlling, and monitoring risks, presents unique challenges for combination products. A fundamental characteristic of combo product risk management is addressing risks from the overall product or system, which necessitates assessment of risks contributed by constituent parts, their interactions, and how these risks interrelate.

Risk management activity for medical products, including combination products, relies on guidance from ISO 14971:2007 (Medical devices – Application of risk management to medical devices) , and ISO 24971:2013 (Medical devices – Guidance on the application of ISO 14971) (ISO 24971) and ICH Q9:2005 (International conference on harmonization of technical requirements for registration of pharmaceuticals for human use). The risk management continuum of planning, assessing, and controlling risks mirrors the same process for combination products as it does for individual drugs, biologics, and medical devices. The basic tenets of the risk management process include risk analysis, followed by risk assessment (an evaluation of the estimated risk related to harm). Based on the harm, risk controls (mitigation factors) are investigated, implemented and validated to ensure the controls function properly. Companies must then have some collation mechanism which captures the combination product's overall residual risk, risk/benefit analysis, and overall conclusion of the product's safety profile, which can be monitored and updated, according to on-going evaluation of relevant data and information.

Key Takeaways

At the end of this event you will have latest industry information available on best practices for risk management activity for combination products.

Agenda

    • 5:15 pm - 6:15 pm Registration Begins (Food Stations and Vendor Booths open)
    • 6:15 pm - 7:00 pm Dinner
    • 7:00 pm - 8:30 pm Welcome, Seminar, Panel Q&A and Closing Remarks

Highlighted Speakers

Jon  Cammack
Jon Cammack
Nevakar, Inc.

Travel

Nevakar, Inc.

1019 Route 202/206, Bldg. K
Bridgewater, NJ

Directions

Registration Fees

Early Registration Price
Registration Type Price By March 18th
PDA Member $59.00
PDA Non-Member $74.00

Substitutions or cancellations are permitted before March 20th.

GROUP DISCOUNT: Special discounts are available for registrants from the same company. A multiple pre-registration discount is applicable for $10 off 3 or more registrants from the same company .

Please contact Katie Ruiz ([email protected]) for multiple attendees discount.





Regular Registration Price
Registration Type Price on March 19th
Late & Walk-Ins $99.00

CANCELLATION POLICY: On March 19th or after, no cancellations are allowed, but substitutions are welcomed.

GROUP DISCOUNT: Special discounts are available for registrants from the same company. A multiple pre-registration discount is applicable for $10 off 3 or more registrants from the same company .

Please contact Katie Ruiz ([email protected]) for multiple attendees discount.





Sponsors

Become a Sponsor

Interested in becoming a sponsor? Learn about opportunities and benefits.

Request Information

Exhibitors

Attendee List Email Scam

Unfortunately, emails are circulating that offer to sell attendee lists for many of PDA’s conferences and events. These emails are sent by scammers.

Note: PDA does not sell its exhibitor or attendee lists, and no third-party is authorized to distribute or sell any lists related to our events. Statements claiming to offer our attendee lists are fraudulent. If you receive emails that propose to sell PDA conference attendee lists, do not engage with the sender and delete the message immediately.

Become an Exhibitor

Interested in becoming an exhibitor? Learn about opportunities and benefits.

Request Information

Got a Question? We have answers

Contact Us

PDA Members Save Substantially