Combination Products Regulation Conference

February 28 – March 1, 2019 | Arlington, VA

Hilton Crystal City at Washington Reagan National Airport

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DAY TWO | FRIDAY, MARCH 1

8:00 REGISTRATION & WELCOME COFFEE

8:10 CHAIRPERSON’S OPENING REMARKS

8:15 CASE STUDY: CONDUCTING GAP ANALYSES TO PRODUCE DESIGN HISTORY FILES FOR LEGACY PRODUCTS
Regulatory teams must ensure legacy products remain compliant with new and updated guidance, including the recently released FDA final ruling for cGMP. The new manufacturing practice rules include provisions pertinent to design history files, posing difficulties for the industry due to lack of sufficient records at the time of legacy products release. It is therefore critical to promptly conduct in-depth gap analysis in the effort of shedding light onto outdated manufacturing strategies and properly document practices from the past in order to achieve compliance.

  • Review of cGMP final ruling on design history files
  • Performing a gap analysis towards legacy product compliance
  • Coordinating appropriate & up to date design history files

Ruby Gulati, Head Combination Product Quality, GENENTECH

 

9:00 OPEN DISCUSSION: UPDATE ON FDA’S POSTMARKETING REPORTING GUIDANCE & COMBINATION PRODUCT REQUIREMENTS
FDA’s release of the draft guidance, “Postmarketing Safety Reporting for Combination Products”, has created concern as regulatory affairs professionals attempt to interpret the information and educate quality teams on compliance requirements prior to the 2019 implementation date. As the reporting processes and timelines for the pharmaceutical and device components of the product differ, regulatory executives aim to effectively manage both procedures. Additionally, as combination products face split jurisdiction, many organizations work to determine whether to inform CDER, CDRH or both, of adverse events and product failures to ensure compliance at all times.

  • Updates to FDA draft guidance & implementation
  • Key differences in reporting for drugs vs. devices
  • Reporting adverse events to either CDER or CDRH
  • Articulating a comprehensive post-market strategy

Dan Visco, Associate Director, Device and Digital Health Center of Excellence, MERCK

 

9:30 COFFEE & NETWORKING BREAK

 

10:00 EXCHANGE GROUPS: FDA FINAL GUIDANCE ON cGMP REQUIREMENTS FOR COMBINATION PRODUCTS
Once the primary mode of action is determined and the combination product is assigned to CDER or CDRH, quality & regulatory executives must prepare the organization’s manufacturing infrastructure to comply with either cGMP regulations for pharmaceuticals, specifically 21 CFR parts 210 and 211, or the device quality system regulation, 21 CFR part 820. This peer-to-peer learning session allows regulatory executives to discuss areas of concerns pertinent to compliant manufacturing practices, as well as the FDA final guidance with quality assurance experts. Delegates will have the choice to join the pharmaceutical or device group to discuss cGMP specific challenges.

MODERATORS:
Andrea Redd, FRESENIUS KABI

Bob Laughner, ASTRAZENECA

Gary Hartman, ASTRAZENECA

Diane Radcliffe, MERCK

 

10:45 CONTROL STRATEGY DEVELOPMENT CONSIDERATIONS: FOCUS ON DRUG-DELIVERY SYSTEMS

  • Review of current control strategy regulatory expectations
  • Defining important attributes such as essential performance
  • Methods to control the most critical characteristics
  • Comparing drug vs. device approaches for control strategy development
  • Submission strategies for combination product control strategies

Suzette Roan, Senior Director, Global Regulatory Affairs, SANOFI

 

11:30 UPDATED ISO 10993-1 AFFECTING COMBINATION PRODUCT BIOCOMPATABILITY & MATERIAL ASSESSMENT

  • Review of changes to updated 2018 ISO 10993-1 Standard
  • Process & material changes impact on biocompatibility
  • Resolutions to last minutes vendor mitigated changes
  • Design platform & semi-platform biocompatibility studies

Michael Song, Sr. Manager, Drug Delivery and Device Development, MEDIMMUNE

 

12:15 LUNCHEON FOR ALL PARTICIPANTS

 

1:15 PANEL: MULTI-TEAM COOPERATION TO EFFICIENTLY BRING COMBINATION PRODUCTS TO MARKET
It takes the effort of various teams, such as product development, regulatory affairs, and quality engineering to achieve the overall goal of compliantly manufacturing and testing an innovative combination product before market release. Each function plays a distinct role, requiring organizations to create a step by step process outlining the overall collaboration timeline and necessary flow of communication. Companies must specify how the work of each function impacts the following activities and compiles throughout the life cycle to create the finished product.

  • Designing a plan & timing for multi-team collaboration
  • Outlining & understanding each team’s distinct needs
  • Impact of each function on the following team’s activities
  • Team interaction differences in drug & device companies

MODERATOR: James Boiani, EPSTEIN BECKER GREEN

PANELISTS:
Jennifer Recknor, PhD, WL GORE & ASSOCIATES

Diane Radcliffe, MERCK

Kirsten Paulson, PFIZER

 

2:00 DETERMINING WHEN THE USE OF SOFTWARE ALONGSIDE A DRUG WILL RESULT IN A COMBINATION PRODUCT

  • Defining software as a device based on intended use & clinical testing
  • Analyzing regulatory implications prior to development & trial design
  • Clarification of FDA requirements & guidance for software components

James A. Boiani, Member of the Firm, EPSTEIN BECKER GREEN

 

2:45 REGULATORY UPDATE ON COMPARATIVE ANALYSES & REQUIREMENTS FOR GENERIC COMBINATION PRODUCTS

  • Defining generic & reference product similarity targets
  • Use of threshold analysis in practice & FDA expectations
  • Critical design attributes & focus on safe user experience
  • Confirming equivalent generic & reference product use error rate
  • Industry best practices to meet large statistical requirements

Andrea Redd, Senior Director, Regulatory Affairs, FRESENIUS KABI

 

3:30 CLOSING REMARKS & CONFERENCE CONCLUSION