October Event: Medical Affairs, Pharmacovigilance, and the Post Approval Landscape

October 1, 2018

 

 

 

REGISTER HERE

 

 

Monthly Program:

 

Wednesday, October 10th, 2018

 

Medical Affairs, Pharmacovigilance, and the Post Approval Landscape

 

FLYER

 

 

Program Speaker:

Daniel Gharbawy, PharmD

Medical Science Liaison

Seqirus and Publicis Touchpoint Solutions

 


Event Agenda:
Date:

Wednesday, October 10th, 2018

 

Time:
5:15 – 6:00 PM Registration & Snacks

6:00 – 6:05 PM Welcome and Announcements

6:05 – 7:05 PM Program Presentation

7:05 – 7:30 PM Q & A

 


LOCATION:

BD (former CareFusion)

3770 Torrey View Court

San Diego, CA 92130 

View Map

 


Program Topic:

Interactions between Medical and Regulatory Affairs are a vital part to the success of a pharmaceutical company and their products. The Medical Affairs division is typically most active following approval but can be involved in publication planning, pharmacovigilance, clinical trial design, investigator sponsored research, and observational studies in support of a product and subsequent submissions. This review will highlight the major functions of medical affairs, pharmacovigilance, and how phase IV research has shaped how the influenza vaccine is used in clinical practice.

 


Program Summary:

This program will focus on the structure and core responsibilities of medical affairs in support of a product pre- and post-approval. The talk will provide updates on:

  • The Medical Affairs Perspective of a Product’s Lifecycle

  • Responsibilities of Medical Affairs · Influenza and Prevention

  • Current Influenza Vaccines and their Clinical Importance

  • FDA Label vs Advisory Committee on Immunization Practices (ACIP) Guidelines

  • The Phase IV Landscape and Pharmacovigilance

 

Speaker Biography:

Daniel Gharbawy has been in the pharmaceutical industry in medical affairs for 9 years. He completed his PharmD at Albany College of Pharmacy and his residency and fellowship at St. Jude Children’s Research Hospital and the University of Tennessee with emphasis in Health Outcomes, Med Safety, and Policy Research. He served as an Associate Professor of Drug Information in the department of Clinical Pharmacy at the University of Tennessee Health Science Center in Memphis, TN before working in the pharmaceutical industry. He served as a Senior Medical Information Specialist and in Medical Affairs with Astra Zeneca, Horizon Pharma, Gilead, Novartis Vaccines, CSL Behring and bioCSL. His expertise has primarily focused on vaccines, but he has also participated in the approval and launch of products in the cardiovascular, rheumatology, gastroenterology and infectious disease therapeutic space. He currently serves as a Medical Science Liaison with Seqirus supporting influenza vaccines and antivirals and interacts regularly with policy and liaison members of the CDC and ACIP. He is passionate about immunizations and eradicating vaccine preventable diseases. 

 

 

Please make your reservation early. The online registration due date is Monday, October 8th, 2018. Credit Cards are accepted online only. Cash and Check are accepted at the door. There will be no refunds for cancellations.

 


Online Pre-registration 

through Monday October 8th, 2018 

credit card only
$15 SDRAN Member, $25 Non-Member


Onsite Registration

cash or check only
$25 SDRAN Member, $35 Non-Member

 

For Questions Email: programs@sdran.org

 

 

DIRECTIONS:

 

From the North 5:

I-5 South toward San Diego

Exit toward Carmel Mountain Rd

Left onto Carmel Mountain Rd

Left onto Torrey View Court

Facility is on the right

 

 

From the South 5:

I-5 North toward Del Mar

Merge onto I-5 local Bypass

Take Carmel Mountain Rd exit (32)

Turn right onto Carmel Mountain Rd

Turn left onto Torrey View Court

Facility is on the right

 

 

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San Diego, CA 92192-7595

 

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