The COVID-19 pandemic has changed the way that sponsors and regulatory agencies interact — potentially on a permanent basis. All formal pre-approval meetings now take place via teleconference or video-conference. Compliance inspections, initially postponed, are have also moved toward virtual and hybrid formats.
Moving from traditional face-to-face meetings to teleconference and video-conference interactions can alter the interpersonal dynamic and the exchange of critical information. It is important to plan, train for, and practice before participating in these virtual meetings. Attendees need to know how to manage the technology and be mindful of online meeting etiquette.
Parexel has guided sponsors through hundreds of virtual health authority (HA) interactions. Here are two main types of regulatory interactions and how to prepare for them:
- Pre-Approval Meetings
- These meetings are critical for sponsors to map out — or in some cases, course-correct — their development programs with guidance from regulators. Three core areas to focus on in advance of these meetings include:
- Content preparation: ensure the meeting agenda is thoroughly planned out. Prepare a set of clear multidisciplinary questions for agency staff and set a logical sequence of topics. Make sure the appropriate SMEs are at the meeting. Background documents should be comprehensive and easily navigable. Designate a moderator who has experience in leading virtual meetings. Pay close attention to initial responses from regulators to guide the discussion in a fruitful direction. Before the meeting, decide who will take the minutes and ensure the minutes are filed promptly with the HA. Have an internal debriefing after the virtual meeting.
- Technical preparation: Select a highly secure platform with the ability to do whiteboarding, have breakout sessions, edit documents in real-time, incorporate slide presentations, and use live chat. Your attendees should be trained in advance on how to mute and unmute, use the "raise hand" function, and adjust their device's camera to an appropriate angle to show their head and shoulders.
- Virtual etiquette: Let your attendees know that they must dress professionally. They should find a quiet space with minimal background distractions.
- These meetings are critical for sponsors to map out — or in some cases, course-correct — their development programs with guidance from regulators. Three core areas to focus on in advance of these meetings include:
- Compliance Inspections
- Prepare diligently for both onsite and virtual inspections, and any combination of the two. Be ready for an onsite inspection of facilities and records at all times. Core areas to focus on include:
- Oversight: Be prepared to demonstrate how you have managed deviations and maintained data integrity in the face of delayed/canceled inspections and employee absences.
- Risk Mitigation: Assess the risks in your supply chain and prepare a detailed plan to mitigate each one. Document how you have protected staff, operations and patient supply during the pandemic.
- Compliance: Demonstrate your strong commitment to maintaining a corporate culture of compliance. This can buy goodwill before and during inspections
- Desktop audits: Be prepared for remote virtual or hybrid inspections. Understand HAs' risk-based algorithm to determine who may qualify for off-site inspections. For example, prior demonstrations of cGMP compliance and a positive production/facility history are qualifiers. Conduct mock off-site cGMP compliance audits.
- Technical preparation: Ensure manufacturing facilities have high-speed internet, cameras, video recording capability, and data-sharing technologies.
- Attitude: Be ready with productive suggestions regarding risk assessment and inspection alternatives that protect public health.
- Prepare diligently for both onsite and virtual inspections, and any combination of the two. Be ready for an onsite inspection of facilities and records at all times. Core areas to focus on include:
Ultimately, it's all about embracing change and being well prepared. For more details, read the full story here.