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Best Practices for Maintaining Pharma Supply Chain Continuity in a Complex & Dynamic Environment

Caroline Rocks, CEng
Best Practices for Maintaining Pharma Supply Chain Continuity in a Complex & Dynamic Environment

Although travel continues to be reduced or restricted across the world, there is an upside: The 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum has now pivoted into a fully virtual conference and virtual executive forum providing attendees located anywhere in the world with real-time engagement with Regulatory and Industry leaders.

Further details and the full agenda for this virtual conference are now launched with a packed program of federal and state regulators and leaders of global pharmaceutical manufacturing companies collaborating to share their experience during Covid-19 under the conference theme ‘Bracing for Impact - Best Practices for Maintaining Pharmaceutical Supply Chain Continuity in a Complex and Dynamic Environment

The focus of this year’s Executive Forum is on the impact of the past six months of 2020 where the industry has had to react quickly and swiftly to Covid-19 to keep medicines in supply to patients and to keep the manufacturing facilities safe for workers. A wide range of issues that faced our industry, and continue to do so, are up for discussion during the Executive Forum including the additional burden on the supply chain from PPE and reagent shortages, the effect on logistics of materials and products with countries imposing travel restrictions differently, the security of the industry’s supply chain during this crisis, the approach the regulatory agencies have taken for inspections during the global pandemic and what regulatory flexibility has been experienced whilst still keeping products safe for all patients.

Each attendee will have the opportunity to participate in one of 5 unique case studies related to existing supply chain challenges and threats facing the industry. Breakout groups will explore each case, examining the potential impact on the supply chain, establishing which aspects of production have been compromised, determining who needs to be involved in creating solutions, and identifying critical interventions necessary. Industry and regulatory experts will be facilitating the discussions in each group. The case study topics include:

  1. Dealing with the Unexpected Situation of a Health Breakout: An OAI (Official Action Indicator) company making medically necessary drugs during a pandemic
  2. Responding to a cybersecurity breach that affects the company’s entire network
  3. Drug shortage scenario in the middle of a pandemic
  4. Managing an organization with multiple sites operating at different levels of quality systems maturity
  5. Dealing with CMOs in the middle of a pandemic

This year, leaders from manufacturing companies Mylan, Biocon Biologics, Lupin Laboratories, SUN Pharmaceutical Industries will be participating alongside regulatory representatives across the US FDA and FDA international offices, including

  • Office of the Commissioner
  • Office of Regulatory Affairs
  • Office of Compliance
  • Office of Pharmaceutical Quality
  • Office of Policy, Legislation, & International Affairs
  • Office of Manufacturing Quality
  • Division of Drug Quality
  • United Kingdom’s Medicines & Healthcare products Regulatory Agency (MHRA)

Each day of the conference has live Q&A sessions with the attendees and the speakers, and identical to last year’s inaugural APAC conference, the live Q&A emphasizes open dialog to give you and your company an opportunity to help your organization. Questions can now be submitted in advance via the 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum page or during the live Q&A sessions.

The Virtual Conference will wrap up with a 2-hour panel discussion with multiple representatives from FDA, MHRA, and CDSCO and Industry participants from the Executive Leadership Forum to discuss the myriad challenges that the COVID-19 pandemic brought to light. Panelists will openly discuss the complexities involved in coordinating agile responses to these obstacles, as well as lessons learned so far from the pandemic.

Attending Virtual Conferences – We All Need a Mindshift Change on Time Zones!

This virtual event will be held live on Monday, 21 September through Wednesday 23, September 2020.

Although the 2020 ISPE Asia Pacific Pharmaceutical Manufacturing Virtual Conference & Executive Forum timings have been selected to suit the Asia Pacific region business hours, it does not stop you from joining virtually from any other part of the world!

Ask yourself, how many times have you set the alarm to head to the airport for an early flight to travel in-person to a conference or arrived home late after business travel?

Head to the conference agenda page where you can view the session details in your own selected time zone to help you set those alarms and to learn more about the virtual conference experience so that you can participate in one of the first truly global events in 2020 discussing Covid-19 with both regulators and industry leader insights.

Learn More & Register