Top Traits of an Excellent Drug Regulatory Affairs Consultant

TOP TRAITS & BENEFITS OF AN EXCELLENT DRUG REGULATORY AFFAIRS EXPERT

As someone who has often been tasked to “find solutions” to the problems that arise when a regulatory professional isn’t brought in early-on in the health product development process, I thought I’d share with you what the role of a Regulatory Affairs professional is and what traits and attributes you will want to see in the person you hire.

Studies that are not well-planned are at risk of being unacceptable from a regulatory authority perspective, and yet still get conducted. As the study proceeds, development is consequently slowed or expanded as people address requirements ad-hoc.  Submissions with inappropriate or insufficient data are prepared, causing submission review delays and its associated costs. There may even be instances where there is a need to go back to the drawing board and start from scratch or close to.

If the rationale behind not bringing a regulatory professional on board early was savings, companies often discover too late that it may end up costing them more on the back end. So, the selecting of an excellent regulatory professional is key and bringing them on at the planning stage, is tantamount.

One question worth asking is: Is there a specific certification that makes someone an effective regulatory professional or is it experience that makes you an expert? Well, the RAC certification from RAPS (of which I am a proud co-author) is well reputed for expertise and is an important foundation. That being said, the patina that develops over time managing a variety of challenging regulatory dossiers makes the most effective experts, in my view.

GOOD, JUST ISN’T GOOD ENOUGH

Here, we look in more detail at the benefits an excellent regulatory professional brings to each stage of the regulatory process (because good just isn’t good enough when we’re talking about the time, money, and value that this industry requires).

STAGE 1: RESEARCH & DISCOVERY

An excellent regulatory professional ensures that the planned development of a health product adheres to international Regulatory Agency requirements with a clear market aim in mind; this includes planning that considers the possibility of expanding the development geographically and facilitating the process of doing – lending flexibility to a development that may need to expand or could benefit from expanding.

STAGE 2: PRE-CLINICAL RESEARCH

In this stage, a regulatory professional ensures that the pre-clinical and the quality (CMC) development programs meet both local and international requirements prior to a first in-man study. This is where the traits of the professional become particularly important. Thorough and detail oriented, a keen logistical ability and regulatory intelligence separate those who are good from those who are great.

STAGE 3: CLINICAL TRIALS AUTHORIZATION

With the aim of obtaining authorization to conduct clinical trials, at this stage the role of a regulatory professional is to ensure that both local and international requirements are met. A regulatory professional coordinates pre-submission meeting, performs efficient and strategic medical and regulatory writing, performs QA and reviews submission documents for local and global compliance, prepares submissions to Health Authorities and ensures regulatory interfacing with them during the preparation, review processes and afterwards as needed.

Considering the significant sums of money involved, it’s not enough to have someone who has done it before or knows what to do, since the attributes of the person/the team can affect outcomes.

 

STAGE 4: REGULATORY PROCESS AND APPROVAL FOR MARKET ACCESS

In this fourth stage, the regulatory professional provides support and knowledge during each step of the registration process. Specifically, your expert should assist you in successfully navigating submission preparation, identify potential concerns ahead of submission time and proactively find solutions. In this phase, expert should perform efficient and strategic medical and regulatory writing, QA and reviews submission documents for completeness as well as local and global compliance, interface with health authorities and makes the regulatory process more predictable until drug approval. Here also, expertise is key.

STAGE 5: COMPLEMENTARY INITIATIVES

Regulatory professionals act not only as guides through the drug development processes at the pre-clinical, clinical phases and registration for market access phases. Experts also prepare provincial reimbursement submissions and provide support in reimbursement negotiations with decision makers. They also review marketing material and advertisement initiatives for compliance with the Food and Drug Regulations and PAAB Code and liaise between PAAB decision makers and sponsor, activities that are also key in the market access profession (combination of provincial initiatives in addition to the Federal ones).

STAGE 6: ONGOING POINT OF CONTACT

When the registration process is complete, and a health product can reach the market, a regulatory professional remains the point of contact with Health Authorities, to ensure compliance behind maintaining a registration.  A true regulatory expert will evaluate the reportability of pharmacovigilance activities in compliance with regulations, evaluate the type of post-approval variations and documents required, prepares and coordinates all post approval submissions to Health Authorities, and coordinates telecoms or face-to-face meetings with them as needed.

IN SUMMARY

Regulatory affairs professionals are your quintessential regulatory process concierge; experts to call on the moment you first begin thinking about planning any medical device, drug or other health product development so that each stage of the process is navigated smartly and skillfully.

Considering the significant sums of money involved in the development process of a drug, medical device or other health product, it is simply not worthwhile to hire or work with someone who is not considered an excellent regulatory expert.

Are separate Clinical Trial Applications required for each protocol?

Does Health Canada require separate Clinical Trial Applications for each protocol?

 

 

Does Health Canada require separate Clinical Trial Applications for each protocol is a question often asked. Presently, drug developers may submit more than one protocol into one single clinical trial application (CTA), when the Application is submitted to the Therapeutic Drug Directorate (TPD). Each protocol would then be considered a different dossier with a different control number per protocol; an approval per protocol would apply. When the CTA is submitted to the Biologic and Genetic Therapies Directorate (BGTD), one protocol only can be submitted per CTA. The upcoming electronic submission requirements for the CTA will likely impose the submission of one protocol per CTA for both Directorates.

Even with these differences, globally the process is quite similar in the US and Canada, however, the terminology used is different and this can cause some confusion.

In the U.S., we see one IND per product under clinical development, which is open to adding new protocol amendments etc… Clinical holds can apply to these INDs and the duration of the holds may vary. In Canada, there is a clinical trial application process, whereby one or more protocols can be submitted at once. New protocols are submitted as new CTAs. There are amendments and notifications that can be brought to clinical trial applications that are approved.

An amendment is considered a major change to an approved protocol or quality dossier, and therefore requires the same 30-day default review period. Minor changes are submitted as notifications within 15 days of the implementation of the change and no review period applies. Now, as mentioned, a new protocol must be submitted via a new clinical trial application. However, cross-referencing to an approved clinical trial application already on file for sections that are not changed, is possible. For example, cross-referencing to an approved investigator’s brochure or to an approved quality dossier. Therefore, it reduces the submission requirement and content. The process is simple and very similar to an IND amendment in the U.S., even if it’s classified as a clinical trial application in Canada.

 

For questions about the Canadian Drug Review & Regulatory approval process that is not covered in this section, please go ahead and contact us directly.

 

Myths of clinical trial and drug approval process in Canada

 

Myths of clinical trial and drug approval process in Canada

 

Canada has become an increasingly popular destination for clinical trials and drug approvals. Despite that, misconceptions persist about everything from approval time to the language used in the approval process. We have identified six of the more common myths about clinical trial applications and drug approval in Canada. Which ones have you believed?

Myth # 1: Obtaining approval for clinical trials takes more time in Canada than elsewhere.

Reality: You’ll receive your approval (No Objection Letter) — or rejection — in 30 days. Once a Clinical Trial Application (CTA) has been submitted, questions can be raised by Health Canada to which an answer (with or without commitment) needs to be provided within 2 days. Once the CTA review is complete, Health Canada notifies the sponsor if the application is found to be acceptable or not. If the CTA is acceptable, Health Canada issues a No Objection Letter (NOL) within the standard 30-day review period; this NOL needs to be received before moving forward with the trial and will be needed for investigational drug importation purpose.

Compare that to the U.S., where the FDA has 30 days to determine whether a clinical hold is necessary or if the clinical trial can start. There is no specific duration for a clinical hold in the U.S..  There is no such hold in Canada.

In most european countries in Europe the target review timeline is 60 days but it often takes more than that to obtain a decision at the national level. EMA is looking into applying  a centralized procedure that will have a longer review period than 60 days.

Myth #2: The requirements for a Clinical Trial Application in Canada are more onerous than elsewhere.

Reality: The content requirements are actually less onerous than in the U.S.  and in the EU. No non-clinical or clinical study reports are required to be submitted within the CTA in Canada. What is needed are the administrative documents plus key scientific documents on which Health Canada bases their review on: the protocol, the informed consent form and the investigator’s brochure, in addition to the standard chemistry and manufacturing data. The Clinical Trial Application is composed of three modules:

  • Module 1 – contains administrative and clinical information about the proposed trial
  • Module 2 – contains quality (chemistry and manufacturing) information about the drug
  • Module 3 – contains additional supporting quality information, when needed.

There can be delays in initiating Clinical Trials in Canada, as in other jurisdictions. For instance, there may be delays in obtaining Research Ethics Board reviews and approvals (a decision independent from Health Canada). Also, sponsors and CROs in North America can prioritize the U.S. sites ahead of Canadian sites for many reasons including patient population (see myth no. 3). Typically, for global studies it can take a few months to get a site up and running in Canada.

It is to note that there are efficient clinical trials start-up experts in Canada that helps with streamlining the study start-up processes in parallel or after the clinical trials application approval.

Myth #3: Because of its population size, recruitment and enrollment are difficult in Canada.

Reality: Enrollment — recruitment and retention — is no more of a challenge in Canada than elsewhere. In fact, the average time from trial set up to first patient visit is three months, with 98 percent of subjects enrolled within the planned study period, according to the Canadian Clinical Trials Coordinating Centre (CCTCC).  One reason for this success is that Canada’s universal healthcare system means coordinated access to patients and better patient data.

Moreover, Canadians are highly educated and interested in research:  More than 70 percent of the population has expressed interest in participating in clinical research, according to the CCTCC.

Finally, as one of the most diverse nations in the world, Canada provides researchers to a broad pool of potential subjects.

Myth #4: All study documents must be provided in English and French.

Reality: Either language is accepted; for regulatory submissions, English is used more often. There are two exceptions: Labels and informed consent forms must be in both languages. Of course, all patient materials for trials in Quebec must be translated into French.

Myth #5: Health Canada’s process for approving new drugs is excessively slow.

Reality: Health Canada have established submission review targets that are respected. Submissions to Health Canada are often delayed, but it has very little to do with the Health Canada process.

Research published in the Canadian Medical Association Journal in 2015, found that the submission of new drugs to Health Canada for approval is systematically delayed compared with submissions to regulatory agencies in the United States and the European Union. Over the years, it has been my experience also. Differences across jurisdictions in approval-processing times play a small role in the delays; differences in the timing of drug submissions are clearly an important factor.

Accessibility to new drugs in Canada is delayed primarily because of delays in submission to Health Canada by pharmaceutical companies and not because of a longer nor more complex approval-processing time at Health Canada.

Myth #6: Drug trials costs more in Canada.

Reality: Canada has the second lowest cost among G7 nations in the management, design and coordination of clinical trials. Only France is cheaper, according to the Canadian Clinical Trials Coordinating Centre. Canada has one of the most attractive tax environments for research and development compared to the U.S. and other G7 countries.

Myth #6.5: The Clinical Trial sponsor needs a Canadian presence.

Reality: The CTA must be signed by a scientific or medical officer residing in Canada. Generally, the regulatory agent or the CRO can sign on behalf of the sponsor.