03/04/2020

"Business Continuity & the Coronavirus: Are Your Pharma Operations at Risk?”"

Bikash Chatterjee, Chief Science & Operations Officer

Bikash Chatterjee proffers a framework for pandemic preparedness to help organizations ensure business continuity, build high-level resilience in all departmental services and sites, and adapt to operational risks.

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02/04/2020

"Evaluating New FDA Draft Guidance-Qualification Process for Drug Development Tools"

Bikash Chatterjee, Chief Operating and Science Officer

Bikash Chatterjee writes that the benefits of FDA’s new qualification process guidance could be profound, both in shortening the development timeline and accelerating the review process.

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01/07/2020

"Meeting Clinical Trial Data Requirements in Asian Markets"

Caitlin Bancroft, Regulatory Affairs Associate

Pharmatech’s Caitlin Bancroft discusses strategies for drug sponsors looking to launch products that are ready for Asia.

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11/01/2019

"Understanding the FDA’s Knowledge-Aided Assessment and Structured Application (KASA) Framework"

Bikash Chatterjee, President & Chief Science Officer

KASA represents an ambitious step forward for the FDA in standardizing and increasing the efficiency of the drug review process. Bikash Chatterjee writes that the challenge will be to set up risk evaluation standards that serve the spectrum of current and future drug therapy programs and leverage industry’s experience in creating and managing these systems.

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10/25/2019

"Hurry Up and Wait: Brexit from a Regulatory Point of View Part 2"

Lynn Hansen, Director, Regulatory Affairs

Lynn Hansen talks about strategic contingency plans, in the form of numerous government guidance/instructions developed for “a Brexit deal” or “no Brexit deal.” When the UK’s Medicines and Healthcare Regulatory Agency (MHRA) becomes the UK regulatory authority once again, it may end up obtaining a seat on International Council on Harmonization (ICH).

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10/24/2019

"Hurry Up and Wait: Brexit from a Regulatory Point of View"

Lynn Hansen, Director, Regulatory Compliance

Lynn Hansen points out the challenges that stem from Brexit for regulators guiding the transition for pharmaceutical, medical device, biotech, and veterinary companies, and the resources in place to ensure that the supply chain of valuable products for many patient populations can be maintained.

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10/15/2019

"Pharma 4.0: Building Quality into Pharma Manufacturing, from Molecule to Medicine"

Bikash Chatterjee, President & Chief Science Officer

Bikash Chatterjee discusses the current and potential impacts of the application of Industry 4.0 concepts to the pharmaceutical manufacturing industry, in an article in Tablets & Capsules, October 2019.

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10/14/2019

"Comparing New US & EU Guidances of the Combination Product Approval Process"

Caitlin Bancroft, Regulatory Affairs Associate

Caitlin Bancroft of Pharmatech examines the EU draft guidance for combination products in part 2 of a two-part series in Pharmaceutical Online. Based on the new guidance issued by regulatory bodies for the U.S. and the EU, manufacturers should adjust their timelines for putting products on the market, and read and comment on the guidance.

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09/24/2019

"Analyzing FDAs Draft Guidance On Premarket Review Of Combination Products"

Caitlin Bancroft, Regulatory Affairs Associate

Designing Combination products for compliance: Caitlin Bancroft of Pharmatech analyzes the new U.S. draft guidance (part 1) and the EU draft guidance in a two-part article in Pharmaceutical Online. Regulators on both sides of the Atlantic risked falling behind when it comes to combination products that are ever increasing in complexity and capability. New EU draft guidance, and U.S. draft guidance, Principles of Premarket Pathways for Combination Products, are important. In this two-part series, Caitlin Bancroft examines the two guidances in detail.

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07/19/2019

"Regulatory Update: Premarket Notification 510K Class 11 Device"

Caitlin Bancroft, Regulatory Affairs Associate

In an article in Pharmaceutical Outsourcing, Caitlin Bancroft of Pharmatech Associates explores several new upgrades to the 510(k) regulatory pathway implemented by the FDA. The agency’s efforts impact many different aspects of the device approval and monitoring systems, including: pre-market requirements, the use of real world evidence in applications, substantial equivalency determinations, and post-market surveillance. Two particularly impactful changes are the newly established Safety and Performance Based Pathway, and the unofficially proposed 10-year cap on predicate devices.

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