How to Determine your Regulatory Affairs Needs

DETERMINING YOUR DRUG REGULATORY AFFAIRS NEEDS

Well-defined and appropriately supported regulatory needs increase the likelihood of successful submissions and market access. So how does one go about determining what those regulatory needs are or might be, especially when embarking in a health product development process at its initial stages?

Also, are there different considerations for pharma, biotech, and investigator led trials?

The short answer is yes.

It takes experience to establish a good health product development strategy and to build trust and communication channels that clearly communicate its details. Get it right, and you can reduce possible errors, save time and money, and lessen the steep learning curves that are common at the start of a mandate.

Together we will look more closely at the considerations for starting to define needs as a whole whether you are Pharma, Biotech or an Academic institution. Let’s look at the unique needs for each:

 

REGULATORY AFFAIRS FOR PHARMA

As a pharma, you have regulatory professionals on board. In instances when in-house staff does not have the expertise required in a specific situation, you will need to hire for a specific need, an expert to work in collaboration with your team. (i.e. orphan drugs, oncology, products that can be considered for priority reviews or NOC with condition, literature-based dossiers, etc.). In instances when workload is very high, or during peaks of activity, external professionals will act as an extension of your team and alleviate congestion, avoid delays and ensure timelines are respected.

 

REGULATORY AFFAIRS FOR BIOTECH

For a biotech, particularly start-ups, it is unlikely to have a regulatory expert on staff. Development is costlier with biology / biotech products which means that cost efficient health product development is key.  Considering the greater health product development costs for biotechnology companies, the impact of failures and errors is more significant.  As a biotech, one of the most significant impact that a regulatory professional’s expertise and regulatory intelligence will have is in streamlining the regulatory process. They will increase efficiency to save you time and money.

 

INVESTIGATOR DRIVEN CLINICAL TRIALS

It isn’t uncommon for investigator driven clinical trials to commence without at least an initial consultation with regulatory agencies. This typically happens when the investigators are unfamiliar with the characteristics and requirements of the regulatory process or don’t consider that the obligations apply equally to investigators as they do pharma and biotech start-ups. For some others, it’s seen as a viable cost-cutting measure until they see once in the trial that, had they had a regulatory professional to draw on in the planning stages, it would save more time, cost less money, and increase efficacy. The obligations are the same whether the sponsor is a manufacture or an investigator and it’s important that the clinical trial initiatives are developed in line with regulatory obligations and Good Clinical Practices (GCPs).  A regulatory affairs professional will be able to ensure the study starts off in observance of the applicable regulations and GCPs.

Also, all studies conducted with a health product have the potential to be included in a registration dossier, making having a regulatory professional involved from the moment you begin to think about planning a study is a significant advantage. An expert who can help plan the health product development efficiently, including clinical development, such that no investment is lost via suboptimal planning is particularly important.

 

HIRE REGULATORY EXPERTS EARLY

Whether you are a sponsor in pharma, a biotech, or an investigator, you will need regulatory support from inception to submission, and a good way to begin a needs assessment is with questions at the research planning stages that shape the thinking process; there are three in particular that are wise to consider at the start.

Best practices assert that the earlier a regulatory expert is brought on, the better the outcomes. A way to look at this is, bringing in a regulatory professional on for the first time at the submission stage, would be akin to hiring a boat maker after you’ve already built a boat and want help to put it in the water.

Hiring at the start to define needs and formulate a strategic regulatory plan produces three significant advantages:  

  1. Ensure the research is relevant and that it will address a medical need / allow for market access so that funds are not misspent.
  2. Establish a smooth relationship with Health Canada teams built on the positive reputation of the regulatory professional.
  3. Accelerate Health Canada’s confidence in the company developing the product because the person interfacing speaks the same language as the regulatory agency.

Deciding whether to hire for the entire process, or part of it.

Needs change and issues can arise because both the product development and regulatory landscape evolve. New laws and regulations, requirements, and even innovations have the potential to affect health product development strategies. Regulatory professionals understand this and work it into their strategic plan, making it possible to anticipate changes and overcome challenges should they arise.  The importance of being responsive to these events means that needing to find, hire and transfer knowledge (and all that this entails) would be wasteful of all resources as compared to having a team or dedicated professional involved (and informed) from the start.

Is it possible to use different professionals for different parts of the process?

Throughout every study there is a need for different skill sets and experience. A team (it can be a small one with proven experience) comprised of professionals with deep knowledge of specializations within the health product development and lifecycle management, not only will enable time to not be lost on learning about the project, but also consistency will be maintained in communications with regulatory authorities.

Still, if you opt to go the route of trying out different professionals for different parts of the process, keep in mind the importance of using a polyvalent expert to optimize information and reduce the time and money investment. It speaks directly to the costs associated to the project(s) learning phases. Subject matter expertise is a driving force in how well the development process unfolds because specialists are able to help you avoid and overcome concerns, changes, challenges or other issues along the way. Their work can help reduce overall cost, alleviate workload, and improve timelines.

To ensure that you’ve hired an excellent professional or firm, please read our post on the subject.

The more consistent the team, the lesser mistakes and errors are encountered. Adherence to regulatory requirements are best achieved with the guidance and support of a regulatory affairs professional. This has many benefits, including increasing the worth of the clinical study or development strategy by respecting regulatory paths, for future inclusion of studies/science in a registration dossier.

 

THE TAKEAWAY

Hire a professional early – very early, in fact, at the planning stage so that your needs can be delineated by an experienced professional who can established a plan that will allow the drug development strategy to be responsive to changes. Regulatory needs may change depending on whether you’re in pharma, biotech, or an independent investigator, consult with a regulatory expert before you begin to ensure that nothing is missing within your health product development strategy and / or your study design, in other words, you will want to make sure that your plans will build a boat that floats.

The Drug Regulatory & Approval Process in Canada – FAQ

FAQ on The Drug Regulatory & Approval Process in Canada

For questions on the Drug Regulatory & Approval Process in Canada or other drug regulatory affairs questions not covered in this FAQ, please go ahead and contact us directly.

 

WHY IS IT IMPORTANT FOR SPONSORS/DRUG MANUFACTURERS TO WORK WITH SOMEONE WITH SPECIFIC EXPERTISE IN CANADIAN REGULATORY AFFAIRS?

Having a Canadian regulatory expert is important to facilitate the global Canadian submission process and all post-approval activities. It’s also important to know that Health Canada prefers speaking with individuals that understand the Canadian medical as well as regulatory environment, whether they are the sponsors or their representatives. The support of a Canadian regulatory consultant is key for the submission of clinical trial applications, New Drug Submissions, or other regulatory initiatives. But it is most important for the global product development strategy, particularly when dealing with niche products used for treating orphan or life-threatening diseases. By understanding Canadian as well as foreign regulatory environments, a Canadian consultant can provide the best strategic initiative for timely access to the Canadian market, keeping the global regulatory initiatives in mind.

The regulatory paths for market access in Canada are essentially threefold. First there is the standard regulatory new drug submission path, then there is the notice of compliance with conditions (NOC/c) path, usually applicable for oncology or other niche products, and finally there is the priority review path. The latest two have shorter review standards at Health Canada.

WHAT ARE HEALTH CANADA’S TIMELINES TO PROVIDE AUTHORIZATION FOR A DRUG TO BE SOLD ON THE CANADIAN MARKET?

The Canadian review timeline for a New Drug Submission (NDS) is competitive. A standard review consists of a maximum of 10 days eCTD validation, followed by 45 days administrative screening where it is verified that the content is acceptable and that no key information is missing. Following the screening period, a 300-day scientific review of the quality, non-clinical and clinical data packages, applies. Therefore, a total of 355 review days applies, before a sponsor obtains a final review decision.

Should the NDS qualify for an accelerated review either under a Priority Review or a Notice of Compliance with condition, the review timelines are shorter.

WHAT IS THE DIFFERENCE BETWEEN THE NOTICE OF COMPLIANCE WITH CONDITIONS AND THE PRIORITY REVIEW?

These two processes apply to drugs used to treat conditions that are serious, life-threatening or for a severely debilitating disease (such as Alzheimer’s disease, cancer, AIDS, or Parkinson’s Disease).

Priority Review (PR) applies to drugs that shows substantial evidence of clinical effectiveness at the end of the clinical trial phases, that is, once the clinical development is completed. The total review timeline is reduced from 355 days to 215 days.

On the other hand, the Notice of Compliance with condition (NOC/c) applies to drugs with promising evidence of clinical effectiveness throughout the clinical trial phases. In summary, the NOC/c can be granted with less clinical data than usually expected, that is with Phase II study results or interim reports of Phase III studies. Approval would be granted to a manufacturer to market and sell that drug in Canada with the condition that the manufacturer execute additional studies to confirm the drug’s benefit and safety.  The total review timeline is reduced from 355 days to 235 days.

The condition needs to be agreed to with Health Canada. Some of the conditions of the NOC/c may include a requirement to closely monitor the drug for safety and adverse reactions and to provide HPFB with regular updates. Once the conditions are met, the designation of “with condition” is removed from the NOC.

To be considered for PR or NOC/c, the drug considered need to meet specific Health Canada criteria, that can be summarized as follows:

  • Offer effective treatment, prevention or diagnosis of a disease or condition for which no drug is available in Canada; or
  • Offer an improved benefit/risk profile over existing therapies, preventatives or diagnostic agents for a disease or condition, not adequately managed by a drug marketed in Canada.

Again, discussing with a Canadian regulatory expert in the early drug development stages can be an advantage for early input to establish the ideal regulatory strategy, as well as to help navigate through the requirements that are specific to Canada, while keeping in mind the global market strategy.

  

WHAT IS A DRUG IDENTIFICATION NUMBER? IS IT SPECIFIC TO CANADA?

A Drug Identification Number (DIN) is a unique eight-digit number assigned to each drug product considered to be compliant to the Food and Drug Act and its Regulations in Canada. It does not apply to radiopharmaceuticals. A DIN uniquely identifies the product manufacturer, product name, active ingredients, strengths, pharmaceutical form and route of administration. This number is assigned to a drug product, provided to the sponsor along with a Notice of Compliance.

WHAT TYPE OF DATA PROTECTION IS APPLICABLE IN CANADA AND HOW DOES IT APPLY?

All drug products containing a new chemical entity are eligible to an eight-year period of market exclusivity. Should the drug product be aimed for a pediatric population, a further six-month extension can apply if the acceptable pediatric data are submitted within the first 5 years of the 8-year period. Health Canada will conduct a preliminary assessment while the drug is under review (NDS) and the sponsor will be notified of the outcome.

Consequently, a subsequent-entry manufacturer is not allowed to file a submission for a generic drug for the first six years of the eight-year period. For products with eligible patents, submission of patent forms within the planned NDS and SNDS is critical to avoid loss of rights and generic entries to the market earlier than the market allows.

IS IT TRUE THAT HEALTH CANADA BASES THEIR DECISIONS IN GREAT PROPORTIONS ON FOREIGN DECISIONS?

This is a major miss-conception. I have seen in many instances, new drugs or new indications approved in Canada while the approval was on hold or refused in foreign countries. Health Canada makes their own independent decisions. However, it is possible (and recommended) to submit the major Q & As issued during the foreign review, along with the Foreign Agency Reviewers Reports. If the submission includes foreign review report, it is recommended to include a completed Foreign Review Attestation Template.  The extent to which Health Canada will use foreign reviews varies. The Canadian regulatory decision can be based on a critical assessment of the foreign reviews, on the Canadian review only or on a mixture of both.

WHY IS IT THAT HEALTH CANADA ASKS FOR FOREIGN REVIEWS?

The provision of foreign review reports in an NDS is not mandatory, but highly recommended. Indeed, they are usually requested at screening if not included within the original submission.

In addition, within the Screening Acceptance letter, Health Canada usually requests the sponsor to share the Questions from foreign regulatory agency reviews and the sponsor’s answers, during the review of the NDS.

In my experience and through my discussions with Health Canada, when the Canadian agency has questions that have already been addressed in a response to questions from a foreign agency, it likely reduces the number of questions to be raised to the sponsor, accordingly.

HOW HAS THE EVOLUTION OF REGULATORY AFFAIRS AFFECTED THE WAY CLINICAL TRIALS ARE CONDUCTED NOW VERSUS 10 YEARS AGO?

With regards to clinical trial applications, Health Canada’s requirements have not changed much. However, they’ve had no choice but to open up to new strategies – novel agents, personalized medicines, or orphan drugs for which there is no official designation yet – and accept novel trial designs. Health Canada is very open to hear how novel therapies can help Canadians and there’s a clear openness and opportunity for collaboration.

WHAT ADJUSTMENTS HAVE DRUG DEVELOPERS HAD TO MAKE TO RESPOND TO CHALLENGES ASSOCIATED WITH TARGETED THERAPEUTICS?

The key adjustments for drug developers have been to increase transparency with the authorities and open up to pre-submission or scientific advice meetings. These meetings become even more efficient when you bring in local experts and key opinion leaders.

The purpose of this is to discuss strategies and requirements with the authorities and to come up with agreements for the drug development activities. Meeting with Health Canada is not a requirement, but it’s highly recommended for novel therapies that would not have the same clinical data package that would usually be required or expected in Canada for market access.

With regards to submission content, contrary to common belief, Health Canada follows similar requirements to those of the FDA and EMA, therefore, usually only minor adjustments are necessary from a FDA or EMA dossier when submitting a marketing application in Canada.

WHAT ROLE DOES CANADA AND CANADIAN DATA PLAY IN THE SPONSORS’ OVERALL REGULATORY STRATEGY?

We know we can’t compete in terms of population, but Canada does have numerous strengths, making it a very attractive host for early phase clinical trials. These strengths include highly trained clinicians, the presence of key opinions leaders, world-class investigators, renowned medical care standards and a well-diversified population, all of which are desirable for testing new drugs. In addition, Canada is one of the top countries for biomedical research productivity and international reputation.

WHAT ADVICE CAN YOU OFFER DRUG DEVELOPERS ABOUT CONDUCTING THEIR CLINICAL RESEARCH IN CANADA?

Canada is an attractive region for clinical trials and we clearly recommend that drug developers come to Canada early in their drug development process, for many reasons.

First of all, we have expert physicians in various therapeutic fields, key opinion leaders with internationally renowned reputations, that are clearly interested in participating in Canadian clinical trials. In addition, we have efficient regulatory experts, CROs and clinical trial start-up facilitators helping with the Canadian process efficiency.

Adding Canadian sites to a multi-centre trial is a great initiative to expose expert physicians as well as patients to novel therapies that will eventually come to market, raising interest, awareness and knowledge. The fact that the Canadian population is very similar to that of the US, makes Canada an interesting extension of the U.S. initiative for patient recruitment.  This way, our Canadian population can benefit from these novel therapies, while adding to the global clinical trial recruitment initiative.

In addition, the Canadian regulatory agency provides a decision within an efficient standard review of 30 days. Also, early Canadian initiative can build the health authorities’ confidence with a sponsor and product by raising awareness, interest and knowledge. This can translate into facilitating the accelerated access to the Canadian market, should the product meet the requirements.

Should the drug be innovative and / or life-saving, we would recommend a strategic registration regulatory strategy, because of the possibility of having a faster approval granted either during the clinical trial phases or immediately upon completion. A meeting with Health Canada would be recommended to validate the strategy, secure agreements that would be part of meeting minutes, included in the upcoming registration initiative.

IS HEALTH CANADA’S CLINICAL TRIAL APPLICATION PROCESS  COMPLEX, SLOW AND INEFFICIENT COMPARED TO THE SUBMISSION PROCESSES IN THE US OR EU?

I’ve heard that many times before but it’s actually the opposite. When the process is properly understood and the sponsor or the representatives have established contacts with Health Canada, the clinical trial application in Canada is relatively simple and so is the review process. The actual submission structure is also simple, and the content requirements are actually less than in the US and Europe.

There are no non-clinical, nor clinical study reports needed in the clinical trial application. What is needed is the administrative documents plus key scientific documents, which are the protocol, the informed consent form and the investigators brochure. There’s two Canadian specific templates required that we need to generate: the protocol summary as well as the overall quality summary. All of these are quite easy to prepare.

The review process is also efficient. A 30-day default review period applies. If questions are raised during the dossier review a response must be provided within two calendar days (exceptions may apply). And by way of comparison, in Canada there is no clinical hold period like in the United States. The review period is always 30 days, whereas in some European countries the review period can be as long as 60 days or more, and in the US it can vary.

Due to the standard 30-day review period in Canada, I believe it does facilitate the ethics review submission planning, which speeds up clinical trial start times. Also, 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.

IS HEALTH CANADA OPEN TO EARLY PHASE TRIAL DESIGNS OR PREFERS LATE PHASE STUDIES WITH COMPOUNDS CLOSE TO APPROVAL?

Health Canada is very open to all phases of clinical trials for both early and late phase. If the product is innovative or has the potential of being granted an NOC/c, we do recommend that sponsors meet with Health Canada early to ensure that the study trial design and the clinical development plan is aligned with the requirements for an accelerated access to market.

DOES HEALTH CANADA REQUIRE THAT ALL STUDY DOCUMENTS AND TOOLS BE TRANSLATED TO FRENCH?

Not at all. Both official languages in Canada, that is English and French, are accepted. That being said, the regulatory dossiers are usually submitted to Health Canada in English. French dossiers, or the supporting documents that are in French, are also acceptable, however, the review could be a little more challenging since most of the Health Canada reviewers are Anglophone. Even if it is not required to submit French documents to Health Canada, the French translation of the informed consent form must be generated and available for francophone patients. Also, there are specific language regulations to respect on Canadian labels. That being said, Health Canada has established standard target review timelines that they respect, which is not influenced by the selected submission language.

DOES HEALTH CANADA REQUIRE THAT ALL SPONSORS HAVE A LEGAL OR SCIENTIFIC REPRESENTATIVE THAT RESIDES IN CANADA FOR CLINICAL TRIAL APPLICATIONS?

A scientific or medical officer residing in Canada that represents the sponsor and who’s responsible for providing an attestation with respect to the clinical trial application or the amendment that is being filed, is required. There is no additional information available in the regulations or guidance related to the Canadian officer. Therefore, any Canadian scientific personnel that are authorized by the sponsor to submit the application on their behalf and to be the representative can be the signatory. Normally the regulatory agent or the CRO can sign the clinical trial application on behalf of the sponsor.

DOES HEALTH CANADA REQUIRE THAT ALL SPONSORS HAVE A LEGAL OR SCIENTIFIC REPRESENTATIVE THAT RESIDES IN CANADA FOR THEIR REGISTRATION DOSSIERS?

No, Health Canada does not. Nonetheless, if the sponsor is not located in Canada, a Canadian importer must be determined and their Drug Establishment Licence (DEL) submitted or amended at least 3 months prior to the submission of the marketing authorization submission (NDS or ANDS) in Canada. This is one of the Good Manufacturing Practice requirements.

That being said, having a Canadian regulatory point of contact in Canada is an advantage for the Canadian regulatory language with Health Canada as well as for dealing rapidly with questions, being in the same time zone as the reviewing regulatory agency.

DOES HEALTH CANADA REQUIRE THAT A NEW CLINICAL TRIAL APPLICATION SUBMISSION BE DONE FOR EACH AND EVERY PROTOCOL WITHOUT EXCEPTION?

This is partly false. 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.

WILL HEALTH CANADA APPROVE CLINICAL TRIALS DESIGNED WITH MORE THAN ONE INVESTIGATIONAL PRODUCT?

Yes, definitely. With the appropriate quality information for both investigational products, Health Canada will review the dossier and approve it if it meets the Canadian requirements, and that will be under the same 30-day default review period.

ARE HEALTH CANADA’S SAFETY FOLLOW-UP POLICIES AND GUIDELINES MORE STRINGENT THAN THOSE IMPOSED BY THE FDA?

No. The requirements are similar in Canada and in the U.S. for clinical trial applications as well as for post-approval initiatives.

DO WE NEED TO PROVIDE HEALTH CANADA WITH THE LABELS OF CLINICAL TRIAL DRUG PRODUCTS?

No, clinical trial drug products labels do not need to be submitted at the time of the Clinical Trial Application. Labels must conform with section C.05.011 of the Food and Drug Regulations, in both official language, and should be provided to Health Canada upon request.

Overcoming Obstacles in the Drug Approval Process in Canada

Staying abreast of drug regulatory landscapes is understandably a challenge; the environment can be challenging to master because of its complexity and the fact that it is continuously changing. Innovations in both science and data collection/reporting methods keep the landscape fluid; it takes rigor and devotion to stay current.

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How to Pick a Drug Regulatory Affairs Consultant

HOW TO PICK THE RIGHT DRUG REGULATORY AFFAIRS PROFESSIONAL

“Know thy self” is as important in life as it is in the development lifecycle of a health product – be it a drug (pharmaceutical, biologic or biotechnical), a medical device or other; particularly as you embark on finding the “perfect” fit in the regulatory employee or consultant you bring on.

In fact, the accelerated use of technologies in life sciences, such as stem cell research, gene therapy, real world evidence, mobile medical devices, and cloud computing to name a few, underscores the necessity for picking the right regulatory affairs professional.

 

MEETING THE CHALLENGES AHEAD

Organizations in the Life Sciences continue to advance effective risk and compliance programs, for instance, by incorporating cyber security practices to safeguard patient data as well as corporate assets. As this new landscape emerges, regulatory affairs professionals will, more than ever, need to be agile and informed enough to meet upcoming and unexpected challenges.

Determining who that regulatory professional is depends largely on your goals. Regulatory professionals must be skilled at taking into consideration complex global dimensions – including multinational supply chains for product manufacturing, global shipping, sales, and various marketing and post-approval surveillance requirements for multiple regions.

In January 2016, the FDA released post-market guidance outlining its cyber security expectations for medical device manufactures already in the field and in the pipeline. Other similar initiatives are being either considered or implemented in various countries.

As of January 2019, agencies such as Health Canada require companies to undergo MDSAP audits. knowledge in this area is essential as companies react to the slow adoption of a global regulatory assessment process.

Because the health product/medical device development process is a complex and ever-changing one; you want to be confident and at ease with who you will have chosen to be at the helm. Here, we will look at what credentials matter, where to find Regulatory Professionals, and fit (i.e. how well the person is likely to interface with your team).

 

WHAT CREDENTIALS MATTER

Most people who make the transition into the regulatory profession have relevant prior experience in related fields (e.g., research and development, quality or a clinical profession). Typically, they will hold at minimum a bachelor’s degree in science, preferably in chemistry, biochemistry, pharmacy, pharmacology, or pharmaceutical technology. However, this alone doesn’t make a good regulatory affairs professional.

There are several organizations and university departments that offer training / certifications in regulatory affairs, whether the candidate is experienced or not. Look for a professional who has the following credentials or training when hiring:

-Regulatory Affairs Certification, the RAC credential, is a well reputed, accredited, post-academic, professional credential for the regulatory professional working in the healthcare product arena, overseen by RAPS.

-RAPS (Regulatory Affairs Professionals Society) is a renowned organization that offer certification in regulatory affairs for medical devices and/or pharmaceuticals. Their numerous online courses cover essential concepts of healthcare product regulation and regulatory issues at each stage of the product lifecycle and for different regions of the world.

–D.É.S.S. en développement du médicament of the University of Montreal, offers courses specific to the global health product development.

-AAPS (Academy of Applied Pharmaceutical Sciences) This certification program provides the comprehensive background and training required of regulatory affairs professionals to address domestic and international regulatory statutes and laws. Its program includes courses on International, Health Canada, and FDA’s laws, regulations, and Guidelines, investigational and marketing applications, technical writing, negotiation skills, development of New Drug Application (NDA) submissions, labeling and drug Information, Common Technical Documents (CTD), Notice of Compliance (NOC), Good Clinical Practices (GCPs), requirements for ongoing post-marketing surveillance and post-marketing changes, communication and management skills essential for the successful regulatory affairs professional in an industry work environment.

Now, as helpful as a candidate’s background or certifications may be, there is one thing that trumps both: experience.

In an industry that is as ever-changing and complex as this one, professionals with a vast amount of experience bring to the table the most valuable skills, knowledge, insight and results.

 

WHAT TRAITS MATTER MOST

There are attributes that are essential parts of all roles and positions. In regulatory affairs, the traits of a candidate matter as much as their experience.

We delved into the role of a regulatory affairs expert and outlined the traits necessary for an excellent professional. You can read the full article here.  In the meantime, these are some of the skills and traits to look for:

TRAITS: Collaborative Leader, Logical, Analytical, Meticulous, Collaborative & Flexible, Diligent, Passionate

SKILLS: Able to perform under stress, Regulatory Intelligence, Project Management, Excellent verbal & written communication

 

WHERE TO FIND QUALIFIED REGULATORY PROFESSIONALS

-RAPs, AAPS, may be able to direct you to a list of graduates.

-LinkedIn is an excellent platform to find professionals who have the experience and certification you are looking for, in particular, look at the various groups within the industry such as:

  • CAPRA – Canadian Association of Professionals in Regulatory Affairs
  • Clinical Research Canada
  • Clinical Research Professionals
  • Drug Regulatory Affairs
  • Pharma Connection Worldwide
  • Professionals in the Pharmaceutical and Biotech Industry
  • RADSP – Regulatory Affairs & Drug Safety Professionals
  • Total Orphan Drug

-When hiring an individual to join your staff, look at the scope and length of experience directly associated to the work you need done. This is a role that a person needs to come in knowing how to do well, not a role that they can take time learning on the job. You’ll want someone seasoned and well connected; someone with the ability to adapt to such difficult circumstances. Flexibility too, is a desirable quality for working in such a complex and changeable landscape; it also happens to be one of the cornerstones of successful consultancies.

-When looking to hire an independent consultant or an outside firm like SPharm, understand that these consultants have gained a range of experiences in different markets and industries, allowing them to bring diversity of thought, experience and expertise to clients. They have also established a strong network relationships within the industry through dealing with multiple clients, colleagues and regulatory agencies. This network is an invaluable asset.

-When hiring a regulatory consultancy, much like SPharm, look at the profiles of their staff and how the team as a whole reflects the necessary broadness of skills and experience. Read any articles, posts and reports they produce because they will demonstrate depth of knowledge. If there are webinars, slide decks, whitepapers, eguides or books they have prepared or authored, watch those to also gauge their depth.

By its very nature, a regulatory consultancy must be absolutely well versed and informed on any and all regulatory specific changes, both locally and internationally. This knowledge presents an enormous advantage and opportunity for businesses seeking to hire them.

In addition to the traits above and the requisite skills and experience, you want to know that the person or company you hire has the respect and recognition of Regulatory Agencies and peers. A large and important aspect of the job is facilitating and navigating the complex regulatory landscape.

 

FIT: A MATCH MADE IN REGULATORY HEAVEN

Finding the right regulatory professional has less to do with the role itself and more to do with alignment to your company culture. This is where the notion of “Know Thy Self” becomes particularly important.

When hiring an individual, look at whether their aspirations match the job. Does the candidate fit into your growth plan for your business beyond filling a need you have right now? How do they want to grow their career in next several years and do they think this job with you can help them fulfill their aspirations? Getting a sense of both aspects will help you determine whether or not there is alignment between the candidate and your company’s goals.

Next, vet them appropriately. Applicable to both candidates and consultancies, it is important to understand how they work and who they are as a co-worker/service provider. You know the experience and traits you’re looking for, now it’s a matter of matching their past performance to the desired output you want. This involves vetting their references and asking pertinent questions to get an idea of their capabilities and work ethic.

Pay attention to the questions they ask; their questions show preparedness and engagement on the part of the candidate. The best hires care about the team they’ll be on or the company they are providing services to; they care about how they can help take your company forward. Questions will demonstrate their knowledge of the industry, and how apt they are – especially service providers – to understand the unique needs and goals of your organization.

Finally, be crystal clear about expectations. They might end up wearing several hats and going above and beyond. Working in the regulatory space isn’t easy, and while it is rewarding, it’s important to make sure candidates know they are going to work in frequent shifting conditions.

Always trust your instincts. You might be in a hurry to hire but hiring right matters more than hiring now.

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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.