BROOMFIELD, Colo., USA — (27 August 2018) — 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.”
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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AMPLEXOR Life Sciences