DAY ONE | TUESDAY, JUNE 11
8:00 REGISTRATION & WELCOME COFFEE
8:50 CHAIRPERSON’S OPENING REMARKS
9:00 ICE BREAKER: NAVIGATING THE CURRENT COMPLIANCE LANDSCAPE FOR REGULATORY SUBMISSION DOSSIERS
When managing regulatory submission timelines, executives are tasked with ensuring dossiers are submitted in the correct format and follow the most updated regulatory standards. Given advancements within the pharmaceutical industry, participants are looking for ways to seamlessly integrate new publishing technology, advance understanding of regulatory guidelines, and efficiently produce submissions. This kickoff event will allow executives to participate in and inform one another of valuable insights pertinent to regulatory operations and submissions in the pharmaceutical and biotechnology space. Furthermore, participants in the warm-up session are also given the opportunity to build contacts with industry peers, kicking off the event networking platform.
9:30 KEYNOTE PANEL DISCUSSION: CONSIDERATIONS FOR THE EVOLVEMENT OF REGULATORY OPERATIONS ROLES AND FORECASTING FUTURE RESPONSIBILITIES
- Advancements in technology: methods of use and impact
- Inclusion of AI
- Opportunities for automation
- Impact of updates to guidelines and publishing procedures
- eCTD 4.0 implementation planning
- Changes within module 1
- Changing regulatory standards and global considerations
- Maintaining industry knowledge
- Emerging markets to consider
- Adjusting efforts according to timeline changes
Dawn Collette, BOEHRINGER-INGELHEIM
Thomas Noto, LEXICON PHARMACEUTICALS
Craig Gassman, VERICEL CORPORATION
Michael Martelli, BLUEPRINT MEDICINES
10:30 COFFEE AND NETWORKING BREAK
11:00 OPTIMIZED TRANSITION TO AD PROMO SUBMISSIONS WITHIN MODULE 1 FRAMEWORK
As pharmaceutical corporations transition to the eCTD 4.0 submission framework, new challenges have arisen surrounding the submission of advertising and promotional materials, which now require a unique submissions separate from traditional NDA and post-market reports. The resubmission of labeling and promotional information is causing a bottleneck for many organizations, who look for clarification into the guidance, timelines of the transition from 3.3 to 4.0, as well as details surrounding binding and non-binding requirements. Learning objectives will include interpretation of current guidance for advertising and promotional submissions, use of hyperlinking in this type of submission, as well as best practices in restructuring existing submissions to streamline processes of ad promo compliance.
Thomas Noto, Senior Director, Regulatory Operations, LEXICON
11:45 eCTD 4.0 SMALL GROUP BREAK OUT DISCUSSIONS: DETERMINING IMPLEMENTATION PLANS
Considerations relating to content, strategy, and available resources assists with the development of training methods designed for regulatory operations groups during the transition to eCTD 4.0. Establishing the structural change eCTD 4.0 has on submissions processes provides executives to prepare submissions groups to assimilate effectively. Facilitated break out discussions divided by company size will provide attendees with an opportunity to exchange approaches to create training strategies in preparation for eCTD 4.0 implementation.
GROUP 1: SMALL PHARMA, 0 – 5 DOSSIERS
GROUP 2: MID PHARMA, 5 – 100 DOSSIERS
GROUP 3: LARGE PHARMA, 100 – 100+ DOSSIERS
FACILITATOR: LaTarsha Jones, Senior Global Regulatory Operations Manager, INDIVIOR
12:30 LUNCHEON FOR ALL SPEAKERS, SPONSORS & ATTENDEES
1:45 – 3:15 SUCCESSFUL EVALUATION, SELECTION, & INTEGRATION OF PUBLISHING SOFTWARE TO SUPPORT REGULATORY OPERATIONS
Throughout the pharmaceutical industry, organizations are purchasing and integrating advanced software solutions with the promise of streamlining operations, reducing redundancies, and speeding up time to submission, only to realize the software ultimately doesn’t meet the specific needs of the regulatory operations function. Overcoming limitations of off-the-shelf products can be time consuming and often as costly as the proprietary development of a customized software solution. A case study presentation highlighting the route to successful software selection and integration will provide attendees with insights into making software work in this highly specialized function.
1:45 PART 1: INDUSTRY CASE STUDY
- Internal evaluation of software needs
- Gap analysis
- Software expectations
- Criteria used in software selection & vetting
- Vendor qualification & communicating needs
- Initial outcomes & projected return on investment
Georgia Hizon, Director, Regulatory Operations, FRESENIUS KABI
2:30 PART 2: INDUSTRY CONSENSUS ON SOFTWARE REQUIREMENTS
Following the industry case study, participants will work in small groups for 30 minutes to create a list of criteria needed from publishing software specific to the regulatory operations & submissions function. The lists will be discussed briefly in a report-back conversation and then combined and shared by Q1 Productions, ensuring each participant walks away from the session with a full list of potential solutions to consider when approaching vendors for software solutions.
Georgia Hizon, Director, Regulatory Operations, FRESENIUS KABI
3:15 COFFEE AND NETWORKING BREAK
3:45 MATCHING LEARNING MODULE: INCREASING EFFICIENCY WITHIN REGULATORY OPERATIONS AND SUBMISSIONS
CASE STUDY: Employing machine learning within regulatory operations lessens time spent on repetitive technical functions and allows submissions teams to devote manpower toward future submissions and outcomes. Embracing the implementation of artificial intelligence positions regulatory operations groups to better leverage saved time evolving as a strategic and central point of the submissions process. Determining the level of impact from the inclusion of AI and machine learning allows regulatory operations groups to forecast future responsibilities.
- Evolvement of the regulatory operations role from AI inclusion
- AI’s impact to submission timelines
- Proposed increased efficiency levels from implementing AI
Rajeev Aneja, Transformation Leader, JOHNSON AND JOHNSON
4:30 GROUP REFLECTION: IMPACT OF MACHINE LEARNING ON REGULATORY OPERATIONS AND SUBMISSIONS
Implementing artificial intelligence throughout regulatory operations increases efficiency levels across submission, and permits groups to adjust the framework of current strategies to evolve job responsibilities. Discussing the areas machine learning impacts the regulatory operations roles on a functional level gives industry executives knowledge to best accommodate change and further develop responsibilities. Regulatory operations executives will reflect on the anticipated routes of change that machine learning contributes to the functions of the position, submission timelines, and the pharmaceutical and biotechnology industry.
5:00 END OF DAY ONE CONFERENCE