2020 PDA Pharmacopeia Conference
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Pharmacopeias have a well-established history to help protect and improve the health of people around the world through public standards and related programs that help ensure the quality, safety, and benefit of medicines. This mission is shared by many stakeholders to the pharmacopeias, including regulatory agencies and the bio/pharmaceutical industry. There are several examples of collaborative responses to address issues relating to the quality of medicines, including control of contamination in glycerin, heparin, and – more recently – nitrosamines in “sartans”.
The global COVID-19 pandemic has challenged traditional approaches to nearly every aspect of life, including the manufacture, delivery, and development of new and existing medicines. The 2020 PDA Pharmacopeia Conference will explore the intersection of global pharmacopeias, regulators, and industry in responding to such crises. Join us virtually to discuss the roles of the pharmacopeias and various stakeholders in maintaining the drug supply, developing new treatments, and explore lessons learned to help address future health crises appropriately.
At the completion of this conference, participants will be able to:
- Understand the roles of pharmacopeias, regulators, and the bio/pharmaceutical industry in maintaining the supply chain and avoiding drug shortages.
- Understand how information is shared – the role of social media and other communications.
- Understand the potential benefit and challenges of pharmacopeial standards, including global pharmacopeial convergence/harmonization for the quality and supply of medicines.
- Recognize progress toward the development of new treatments, including compounded drugs and unlicensed medicines, re-purposing of existing medicines, discovering new therapies and supportive treatments, and the race to find new preventative medicines/vaccines.
- Recognize where we are, what we have done, what we have learned, and where we are going in responding to public health crises.
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GROUP REGISTRATION DISCOUNT: Register 3 people from the same organization as a group (at the same time) for the event and receive the 4th registration free. Other discounts cannot be applied.
GENERAL TERMS AND CONDITIONS: PDA will send you a confirmation letter within one week of payment being received. You must have this confirmation letter to be considered enrolled in a PDA event. If you have submitted a purchase order or requested an invoice, please be advised that a credit card guarantee is needed. PDA reserves the right to modify the material or speakers/trainers without notice or to cancel an event. If an event is cancelled, registrants will be notified by PDA immediately and will receive a credit (registration fee paid). PDA will not be responsible for any costs incurred by registrants due to cancellation. Please note that the attendee list is shared with attendees, trainers, and exhibitors and may be used to follow up on specific areas of interest after the event. Video, photo, and audio recordings are prohibited at all PDA events.
CANCELLATION: If a cancellation request is received 30 days before the event, a credit (registration fee paid minus a 200.00 USD/EUR processing fee) will be given. No credits will be given for cancellation requests received less than 30 days before the event. Cancellation requests must be emailed to [email protected].
Day 1
Pre-Recorded Sessions
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Of Pharmacopeias and Pandemics: Setting the Stage |
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Pharmacopeias have a well-established history to help protect and improve the health of people around the world. But the global COVID-19 pandemic has challenged traditional approaches to nearly every aspect of life, including the manufacture, delivery, and development of new and existing medicines. What is the intersection of this public health crisis and the work of pharmacopoeias and stakeholders? This session will provide context for the overall conference, with pre-recorded presentations from the co-chairs and by some of those who have been impacted, including a pharmacist who contracted COVID-19 and a patient advocacy group representative. |
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Welcome and Opening Remarks from Conference Co-Chair From the Ski Slopes to the ICU: My COVID-19 Journey Patients' Perspectives Conference Lead-in from Conference Co-Chair |
Day 2
Tuesday, September 29
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10:00 a.m. - 2:30 p.m. | Maintaining Drug Supply During the Pandemic: The Role of the Pharmacopeia and Standards |
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Ensuring the timely and assured supply of medicines to patients is absolutely critical to the global healthcare response to the pandemic. Any interruption to supply could have serious consequences, whether for existing therapeutics in clinical trials for the treatment of COVID-19, medicines needed to support seriously ill patients in hospitals or consumer healthcare products. This session will consider the complex and challenging experiences of the pharmacopeias and industry stakeholders supporting the continued supply of medicines. For example, maintaining the supply of reference standards and the role of standards in supporting a supply chain under stress for both licensed and unlicensed medicines. With speakers from across the world, this will be a unique opportunity to learn how pharmacopeias, regulators and industry have responded and share your experiences and opinions. |
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10:00 a.m. – 10:05 a.m. | Welcome and Recap of Pre-Recorded Sessions 10:05 a.m. – 10:10 a.m. | Framework for the Session 10:10 a.m. – 10:40 a.m. | USP's Pandemic Response: Helping Ensure the Supply of Quality Medicines 10:40 a.m. – 11:00 a.m. | Drug Shortages: A Creative - Disruptive - Transformative Solution Is Required 11:00 a.m. – 11:20 a.m. | Systems Thinking, Pandemics, and Pharmacopoeias 11:20 a.m. – 11:40 a.m. |Overview of NIFDC and Support for Regulation 11:40 a.m. – 12:00 p.m. | Q&A 12:00 p.m. – 12:30 p.m. | Break 12:30 p.m. – 12:50 p.m. | The European Paediatric Formulatry 12:50 p.m. – 1:10 p.m. | USP Compounding Standards 1:10 p.m. – 1:30 p.m. | Pharmaceutical Industry Reference Standards - Disaster Planning 1:30 p.m. – 1:50 p.m. | Japanese Efforts to Ensure Supply of Basic Pharmaceuticals and the Role of Pharmacopoeia 1:50 p.m. – 2:10 p.m. | Overview of the Chinese Pharmacopoeia 2020 Edition 2:10 p.m. – 2:30 p.m. | Q&A |
Day 3
Wednesday, September 30
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10:00 a.m. – 1:30 p.m. | Developing New Treatments: The Role of the Pharmacopeia and Standards |
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In such unprecedented pandemic situation, all those involved in ensuring that safe and appropriate medicines reached the patient faced new challenges. For example, most of the COVID-19 candidate vaccines developers are small or medium sized enterprises or universities with little or even no knowledge of the regulatory landscape (including Pharmacopeias). Additionally, new, and sometime controversial information about possible COVID-19 treatments using already existing therapies such as remdesivir, hydroxychloroquine, dexamethasone, Interferon β and others were published (e.g. in the media). This session will give the floor to speakers from different areas (Regulators, Pharmacopoeias, Industry) who will share how they approached this situation to best meet their duties: protection of Public Health and providing the best available treatment to patients in the shortest time possible. |
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10:00 a.m. – 10:05 a.m. | Recap of Tuesday's Session 10:05 a.m. – 10:10 a.m. | Framework for the Session 10:10 a.m. – 10:30 a.m. | USP Biologics Vaccine Strategy: Our Approach to Standards and Protecting the Public Health 10:30 a.m. – 10:50 a.m. | Rapid Response to COVID-19: The Role of CEPI in Vaccine Development 10:50 a.m. – 11:10 a.m. | Impact of Excipients in Vaccines: Material Qualification and Sourcing Issues for Janssen Vaccines 11:10 a.m. – 11:30 a.m. | Vaccines Q&A 11:30 a.m. – 12:00 p.m. | Break 12:00 p.m. – 12:20 p.m. | Monograph Availability of COVID-19 Investigated Drugs in World Pharmacopeias 12:20 p.m. – 12:40 p.m. | Azithromycin: Compatibility and Simulated Dosing with Feeding Tubes 12:40 p.m. – 1:00 p.m. | Standards to Support the Development of New Treatments for COVID-19 1:00 p.m. – 1:30 p.m. | New Therapeutics and Regulatory View Q&A with Panelist |
Day 4
Thursday, October 1
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10:00 a.m. – 11:30 a.m. | Maintaining Transparent Communication in Digitally Overloaded Times |
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With increasing digitalization there is also an increasing challenge of filtering this overload of information, assessing its accuracy, and determining appropriate action. Recent examples are therapeutic and vaccine development for COVID-19, as well as reported glass container shortages. Other examples include contamination concerns: nitrosamines, heparin, and glycerin. You will have a chance to hear from experts, ask questions, and provide your own experience on these important topics. This interactive session will explore two broad areas of communication:1. Sources of information (and misinformation) and how that is translated to the public, media, etc. 2. How pharmacopeias, regulators, and other stakeholders share critical information (including Pharmacopeia Forum, Pharmeuropa, and internal company communications). |
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10:00 a.m. – 10:05 a.m. | Recap of Wednesday's Session 10:10 a.m. – 11:30 a.m. | Panel Discussion |
11:30 a.m - 12:00 p.m. | Break
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12:00 p.m. – 2:00 p.m. | Conclusions: What Have We Learned? Where Do We Go From Here? |
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The closing session begins with an exploration of the impact of the pandemic on efforts aimed at achieving global harmonization of pharmacopeias. The moderators will then take stock of prior sessions from the conference, including a summary of key points and outcomes, as well as consideration of possible actions. A panel/round table discussion will provide an opportunity for conference attendees to engage in constructive dialogue to enable even more effective outcomes for future public health crises. |
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12:00 p.m. – 12:30 p.m. | Global Harmonization Post Pandemic – A Prioritized Wish List 12:30 p.m. – 1:45 p.m. | Panel Discussion 1:45 p.m. – 2:00 p.m. | Closing Remarks and Final Wrap-up from Conference Co-Chairs |
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