Market Overview

AMPLEXOR's August Webinars Includes RIM Solution Implementation and Compliance Risks in Product Launch Pre-Approval Period

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AMPLEXOR
Life Sciences
has announced its latest series of webinars for
August, focusing on implementing foundational regulatory information
management (RIM) and how to address regulatory and compliance risks
during the product launch pre-approval period.

The first webinar - Implementing
Foundational RIM in a Small and Medium Size Enterprise – Does Size
Matter?
– takes place on 29 August and will be presented by Vahé
Ghahraman, Head, Global Regulatory Operations, Alexion. Vahé will share
his experiences about Regulatory Information Management (RIM)
implementation at Alexion, outlining Alexion's RIM scope, process and
strategy as a small to medium global bio-pharma company and comparing
that to other implementations.

The second webinar in AMPLEXOR's August program - Addressing
Regulatory and Compliance Risks During the Product Launch Pre-Approval
Period
- will take place on 30 August and will be presented by
Howard Dorfman, an industry authority with more than 40 years'
experience in healthcare compliance and regulatory oversight.

In this first of a two-part webinar, Howard will focus on pre-approval
industry activities that present increased risk before a product is even
launched, illustrating that with examples of processes and procedures
that have an effect on corporate behaviour during this time, such as the
need to present accurate data to a variety of audiences.

"We are fortunate to have two real industry experts joining us for our
August webinar program," said Elvis Paćelat, Executive Vice President,
Life Sciences, AMPLEXOR. "Alexion has demonstrated a smart strategy and
approach around its RIM implementation and Vahé will share his insights
that will be of interest to others embarking on their own RIM journey.
Managing regulatory and compliance risks is an issue in the industry,
especially in the crucial pre-launch phase, so we are delighted to hear
from Howard and benefit from his many years' experience and know-how in
this matter."

The Implementing Foundational RIM in a Small and Medium Size
Enterprise – Does Size Matter?
webinar will take place on 29 August:
Session A: 10 a.m. EDT / 16:00 CEST and Session B: 1 p.m. EDT / 19:00
CEST. To register for this webinar, click
here
.

The Addressing Regulatory and Compliance Risks During the Product
Launch Pre-Approval Period
webinar takes place on 30 August: Session
A: 10 a.m. EDT / 16:00 CEST and Session B: 1 p.m. EDT / 19:00 CEST To
register for this webinar, click
here
.

About the Presenters

Vahé Ghahraman, Head, Global Regulatory Operations, Alexion.

Vahé has more than 17 years of industry experience with a focus on
regulatory information management, global publishing, and submissions
strategy and IT systems. He has previously held various roles including
consulting at Datafarm, Parexel, Millennium, Dyax, Takeda, and Dimension
Therapeutics. He has extensive experience in establishing regulatory
operations functions within growing bio-pharma enterprises.

Howard Dorfman, Founder, H.L. Dorfman Pharmaceutical Consulting

Howard Dorfman is the Founder of H.L. Dorfman Pharmaceutical Consulting,
LLC, providing compliance, regulatory and risk management consulting
services to pharmaceutical and biotech companies and law firms. His
areas of expertise include FDA regulatory law, fraud and abuse, health
care compliance, risk management, corporate governance, and litigation.

About AMPLEXOR Life Sciences

AMPLEXOR Life Sciences assists organizations developing pharmaceuticals,
medical devices, and biotechnology with launching products and breaking
into new markets quickly. Our proven solutions as well as professional
and business services expedite the creation and delivery of consistent,
compliant, high-quality and global content – both physical and digital.

AMPLEXOR Life Sciences boasts a rich 25+ year history of serving
pharmaceutical producers, medical device manufacturers, and
biotechnology companies.

For more information, go to www.amplexor.com/lifesciences.

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