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Category Archives: Regulatory Affairs

Getting in Tune: The ICH Process of Harmonizing Guidelines

August 16, 2018 | Cheryl Ainslie, PhD, Clinical Research Scientist II  │ Regulatory Affairs Services

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“The only constant is change,” commonly attributed to the Ancient Greek philosopher Heraclitus, is as true today as it was in 500 BCE.  In the global industry of drug development, the conduct and reporting of clinical trials may change to a small degree with every new study proposed.  But what happens when there is growth or momentum for change that could impact the industry as a whole?

The Role of ICH

In a previous post, Ilana discussed the International Council for Harmonisation (ICH, previously called the International Conference on Harmonisation) guideline for clinical study report authoring, Efficacy Guideline 3 (E3).  The goal of the post you are reading is to take a step backward and explain how ICH guidelines are proposed, evaluated, and (possibly) adopted.  This process is key to understanding the function and operation of ICH to ensure that drug development is highly efficient and scientifically sound.

Created in 1990, the ICH of Technical Requirements for Pharmaceuticals for Human Use comprises experts from regulatory authorities and the pharmaceutical industry in the EU, US, and Japan.

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Ready to Submit Your Initial IND?

April 20, 2018 | Kasturi Puranam, PhD | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

I hope that you have read our previous blog posts on IND filing and have learned about the types of INDs, when you need to file an IND, and pre-IND activities. Continue reading this post to understand the process of submitting an initial IND and the subsequent IND-related steps to take as you proceed towards your marketing application.

Let us start with …

IND components

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Before you file your IND…

March 14, 2018 | Preeti Chugha, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

You’ve determined that you need to file an IND to conduct human trials in the US. What do you need to do before you submit your IND? While INDs can be opened at any stage of product development, the main focus of this post is on pre-IND activities for those being submitted to support first-in-human studies.

Nonclinical and CMC activities

During a new drug’s early preclinical development, it is necessary to determine that the product will not expose humans to unreasonable risk when used in limited, early-stage clinical studies, and that it exhibits pharmacological activity that justifies commercial development. To that end, nonclinical and chemistry, manufacturing, and control (CMC) data should be collected to include in an IND and support the initiation of a clinical trial. These components of an IND include:

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The Ins and Outs of INDs

February 16, 2018 | Kathryn Tworkoski, PhD, RAC | Clinical Research Scientist II | Regulatory Affairs, Drug Development Consulting

Introducing a new therapeutic agent to human patients can be simultaneously exciting and nerve-wracking. Over the years, we’ve had a lot of questions about the best way to prepare for an Investigational New Drug (IND) submission. So we’ve decided to tackle those questions in a series of blog posts. In this introductory post, we’re going to focus on some background information that will help explain the overall purpose and requirements of an IND.

Let’s start with . . .

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RAPS Regulatory Convergence 2017: A Recap

October 11, 2017 | Mark A. Cierpial, PhD, RAC; Principal Regulatory Consultant | Regulatory Affairs

The Regulatory Affairs Professionals Society (RAPS) held another successful annual meeting (or “Regulatory Convergence” as it’s called) last month. This year’s Convergence was held at the Gaylord Resort at National Harbor on the DC Waterfront and offered more than 70 educational sessions presented by over 200 expert speakers from around the world. In addition, 135 companies, offering a wide range of regulatory services and solutions, were in attendance in the exhibit hall.

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