Name: Pharmacovigilance Oversight and Inspection Readiness Virtual Summit
Start: 12/01/2023 01:30 PM +00:00
End: 12/01/2023 08:30 PM +00:00

The 3rd REMS Innovation Summit will continue to innovate on the Risk Management space in both content and experience for everyone in attendance. Bringing back the audience&rsquo;s favorite interactive roundtable discussions to enjoy the most engaging and complete REMS Experience! We will focus on REMS assessment reports, inspection readiness, the regulatory landscape including the new Guidance on Structured Product Labeling, the newest tech, and AI breakthroughs while focusing on reducing patient burdens.

Risk Evaluation and Mitigation Strategy

Pharmacovigilance is responsible for the collection, assessment, identification, and communication of all drug safety information. In addition, PV focuses on the processing of safety information, adverse event reporting, and keeping up to date with guidelines and regulations.
The 2nd Pharmacovigilance Oversight and Inspection Readiness Summit will focus on how to achieve safety inspection readiness through effective partner collaboration and quality optimization strategies.
&nbsp;
&nbsp;

Pharmacovigilance Oversight and Inspection Readiness

Let Momentum Virtualize Your Retreat, Recruitment, Training or Client Event - As most industries continue to adjust to life with limited to no live meetings or events, the need to create a valuable and impactful experience has never been greater. Whether it is a firm retreat, recruitment effort or client event, Momentum can virtualize your program and deliver a seamlessly executed program that removes any delivery risks and enhances the digital experience, all for the fraction of the cost of a traditional venue and without any subscriptions or long-term commitments.&nbsp;
vCaaS&trade;, virtual Conference as a Service, leverages our best in class technology platform, an assortment of virtual event provider relationships, and the meticulous nature of our event planning mindset to create a customized virtual event and social interaction platform that can seamlessly deliver content to an audience of your choosing. Our services can be used for:
<ul>
<li>Law firm and company retreats</li>
<li>Client events</li>
<li>Training courses</li>
<li>Recruitment activities</li>
<li>Expert roundtables</li>
<li>Bespoke conferences</li>
</ul>
As a full-service events company, we will also consult on session design and timing for the virtual environment, leveraging best practices, and provide complete end to end project management, acting as an extension of your team and &ldquo;general contractor&rdquo; for your retreat.
We can incorporate any or all of the following elements into your event:
<ul>
<li>Keynote addresses</li>
<li>Professionally produced video content (pre-recorded or live)</li>
<li>Multiple roundtables &amp; breakouts</li>
<li>Private meeting rooms</li>
<li>Virtual cocktail receptions</li>
<li>Embedded video chat</li>
<li>1:1 Matchmaking</li>
<li>Content delivery</li>
<li>Brand activation</li>
<li>Exhibition activation</li>
<li>Social events</li>
<li>and much more&hellip;</li>
</ul>
By working with Momentum, you can sit back and rest assured that your next event will be in safe hands with an events company that has 100+ combined years of executive leadership experience and 10+ years of working with dozens of virtual event platforms.
Don&rsquo;t waste your time evaluating the hundreds of virtual event platforms currently on market or stress of how to execute your digital event at the high standard your company expects, let Momentum take all the hassle off your plate and allow you and your team to focus on your core responsibilities.&nbsp;

Conference as a Service v(CaaS™) by Momentum

Welcome and Opening Remarks
&nbsp;
Jonathan Banchs, Senior Director of Content &amp; Experience, Momentum Events
&nbsp;
Recognize the Value of PV Systems to Streamline Communication and Achieve Inspection Readiness&nbsp; 
<ul>
<li>Technology implementation helping the data collection from AER and reduce the burden of HCPs, partners and patients</li>
<li>Analyze the different system options like quality, safety and vigilance systems that can be applied to your PV and drug safety&nbsp;</li>
<li>Innovate, adapt and unify processes and information for every stakeholder involved in PV</li>
</ul>
&nbsp;
Sameer Thapar, Professor Drug Safety Graduate Program, TEMPLE UNIVERSITY
&nbsp;
Closing Remarks
Jonathan Banchs, Senior Director of Content &amp; Experience, Momentum Events

Sameer Thapar

WELCOME AND OPENING REMARKS/PV SYSTEMS, TECH AND INSPECTIONS/CLOSING REMARKS

Ensure Streamline Communication Between Partners, CROs and Sponsors 
<ul>
<li>Communication is key! Make sure everyone is on the same page and has updated information</li>
<li>Call Centers, outsourced partners, off-site teams, vendors and everyone involved need to be on the same page and need to have a clear understanding of their roles and responsibilities when facing an inspection</li>
<li>Notify proactively when an inspection or an audit is taking place to provide time and opportunity to have all the information required available</li>
</ul>
&nbsp;
Garry Flounders,&nbsp;Senior Process Lead - Biosimilars, BIOGEN

Garry Flounders

PHARMACOVIGILANCE OVERSIGHT

When the networking break has started click the &ldquo;Join Session&rdquo; button. You will then be connected to Zoom. Once you are connected to Zoom you will be broken out into breakout rooms for further networking and peer to peer engagement!

NETWORKING BREAK

Discuss Strategies and Best Practices for PV Inspection Preparation and How Preparation Efforts Change Depending on the Inspecting Agency&nbsp; 
<ul>
<li>Evaluate different approaches for safety inspection preparation&nbsp;</li>
<li>Discuss the known areas of focus amongst the varying regulatory agencies</li>
<li>Streamline cross-functional collaboration and communication to ensure everyone is on the same page. Evaluate best practices for leveraging learnings&nbsp;and findings from previous inspection experiences</li>
</ul>
&nbsp;
Helena van den Dungen,&nbsp;Senior Director PV Quality Assurance, ASTELLAS
Kal Elhoregy,&nbsp;Director, REMS Programs |Drug Safety and Pharmacovigilance, AMNEAL PHARMACEUTICALS
Jaylaxmi Nalawade,&nbsp;Associate Director - Pharmacovigilance and REMS, LUPIN PHARMACEUTICALS
Randy Levitt,&nbsp;Director, Pharmacovigilance and Medical Affairs, PALADIN LABS

Helena Van den Dungen

Kal Elhoregy

Randy Levitt

Jaylaxmi Nalawade

PANEL DISCUSSION: PV INSPECTION PREPARATION

<ul>
<li>Explain how patient Safety and Pharmacovigilance need to work together.</li>
<li>What is the importance to keep the patient safe before and after post-marketing activities</li>
<li>Why is important to strengthen Pharmacovigilance outside of Pharma company ( Pharmacovigilance in hospitals, pharmacies and etc).</li>
</ul>

Janaina Brothers

THE IMPORTANCE OF PHARMACOVIGILANCE TO KEEP PATIENT SAFETY

Leverage Learnings and Challenges from PV Audits to Promote and Ensure Inspection Readiness
<ul>
<li>Examine the different types of pharmacovigilance audits that can be executed at various levels/components of the pharmacovigilance system</li>
<li>Embrace the audit as an &ldquo;inspection exercise&rdquo; and a critical piece of your inspection preparation</li>
<li>Maximize the different audits to gather useful insights that will help reduce the inspection risk</li>
</ul>
&nbsp;
Josue Bautista Arteaga,&nbsp;GCP/PV Auditor and President of the Mexican Drug Safety Society, NOVARTIS

Josue Bautista Arteaga

PHARMACOVIGILANCE AUDITS

LUNCH BREAK

<ul>
<li>Recognize PV requirements in Brazil</li>
<li>Describe the path to implement ICH guidelines and the challenges for pharma companies.</li>
<li>Illustrate challenges and opportunities</li>
</ul>
&nbsp;
Raphael Pareschi,&nbsp;Patient Safety Lead/ Head of Pharmacovigilance Brazil, ROCHE

Raphael Pareschi

PV REQUIREMENTS IN BRAZIL FOLLOWING ICH GUIDELINE IMPLEMENTATION

Learn the Current State of PV Affairs in Argentina
<ul>
<li>Applicable Pharmacovigilance Legislation in Argentina</li>
<li>Recent changes and challenges</li>
<li>LHA Interaction with the Pharmaceutical Industry</li>
</ul>
&nbsp;
Carla Massironi, Country Safety Head Argentina, Global Pharmacovigilance, SANOFI

Carla Massironi

PV LANDSCAPE IN ARGENTINA

Be sure to have continuous exercise throughout the product life cycle to evaluate the favorable and unfavorable effects of the drug.
<ul>
<li>Weigh the benefit and risks of different forums and initiatives</li>
<li>Discuss the appropriate usage of metrics</li>
<li>Consider involving patients to factor in their perspectives on the benefits and risks of the product</li>
</ul>
&nbsp;
Siva Kumar,&nbsp;Global Phv Surveillance Physician Sr Manager, Medical Scientific Unit, TEVA
&nbsp;
Closing Remarks
&nbsp;
Jonathan Banchs, Senior Director of Content &amp; Experience, Momentum Events
&nbsp;

Agenda

Speakers11 Speakers

Kal Elhoregy

Helena Van den Dungen

Garry Flounders

Jaylaxmi Nalawade

Josue Bautista Arteaga

Randy Levitt

Siva Kumar

Raphael Pareschi

Janaina Brothers

Sameer Thapar

Carla Massironi

Booth3 Booth

Risk Evaluation and Mitigation Strategy

Pharmacovigilance Oversight and Inspection Readiness

Conference as a Service v(CaaS™) by Momentum

Agenda

Speakers.css-1f6omqm{margin:0;font-size:1.4rem;font-weight:500;line-height:1.5;color:#5d5d5d;font-family:'Poppins',sans-serif;margin-left:0.8rem;}11 Speakers

Kal Elhoregy

Helena Van den Dungen

Garry Flounders

Jaylaxmi Nalawade

Josue Bautista Arteaga

Randy Levitt

Siva Kumar

Raphael Pareschi

Janaina Brothers

Sameer Thapar

Carla Massironi

Booth.css-1drp72d{margin:0;font-size:1.4rem;font-weight:500;line-height:1.5;color:#5d5d5d;font-family:'Poppins',sans-serif;color:#000000;margin-left:0.8rem;font-weight:400;}3 Booth

Risk Evaluation and Mitigation Strategy

Pharmacovigilance Oversight and Inspection Readiness

Conference as a Service v(CaaS™) by Momentum

Speakers11 Speakers

Booth3 Booth