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Who should attend ComplianceOnline Pharma Summit 2016 – Risk Control and Compliance
We are seeking suggestions from the pharma/biotech community in preparation for the Agenda of this Summit.This survey asks your opinion on what's important to you and what we should include.
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We are seeking suggestions from the pharma/biotech community in preparation for the Agenda of this Summit.This survey asks your opinion on what's important to you and what we should include.

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Seminar Summary:

This summit will provide a venue for industry experts, policymakers, manufacturers, inventors and clinician to discuss and debate these challenges as well as explore new strategies and opportunities for growth.  (see full course description)

 
 
 

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Training Course Syllabus:


ComplianceOnline Pharma Summit 2016 – Risk Control and Compliance

Description:

Pharmaceutical and biotechnology companies across the globe face unprecedented challenges in the dynamically changing clinical, regulatory and business landscape. Aging populations, chronic diseases, technology and treatment advances are expected to spur health sector growth in 2016. As we approach 2016, it is imperative that leaders in the pharma space understand the trends and shifts happening around them.

This summit will provide a venue for industry experts, policymakers, manufacturers, inventors and clinician to discuss and debate these challenges as well as explore new strategies and opportunities for growth. This event therefore gives professionals – whether they are new entrants in the field or middle management or veterans – to interact with the leading minds in the industry about the current state of laws and technology and government oversight and more.

The panel discussions, debates, workshops and exhibitions will also throw light on the direction the industry will take in the future – making it all the more important for today’s pharma professionals to actively take part in this Summit.

DAY-1 Sessions

Registration and Breakfast

Intorduction to ComplianceOnline & Summit

Future of Healthcare, NOT Embodied by Government Reform - Inspirational Keynote

FDA Approval Licensing Process for Products Containing Novel Adjuvant

FCPA and Internal Control Issues Across Pharmaceutical Industry

Networking/Tea Coffee Break

Drugs Patent & Trademark

Pharmacovigilance Audit Strategy

Biosimilars

Lunch Break

Right-Sizing R&D for Optimum Productivity

Demonstrating Value to Attract New Investments

Clinical Trials--Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for Comments

Challenges Associated with Stakeholders Amidst Mergers & Acquisitions

Vendor Governance / Supply Chain Management

DAY-2 Sessions

Registration and Breakfast

FDA´s View on Domestic Manufacture of APIs in the Country

Impact of Sunshine Act /Open Payments

eHealth System

Networking Coffee/Tea Break

Data Integrity in Clinical Trials

Clinical Trials--Assessing Safety and Efficacy for Diverse Populations; Public Meeting; Request for Comments

Lunch Break

Standardizing Packaging & Labelling Globally

Drugs Patent & Trademark

Auditing R & D -
Key Risk Areas in Pre-clinical Development
Clinical Development, including Use of CRO’s

Global Strategies


Seminar Summary:

This summit will provide a venue for industry experts, policymakers, manufacturers, inventors and clinician to discuss and debate these challenges as well as explore new strategies and opportunities for growth.  (see full course description)

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