Top Traits of Drug Regulatory Affairs Consultants

TOP TRAITS OF DRUG REGULATORY AFFAIRS CONSULTANTS

We have 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. As such, we thought we’d share with you what the role of a Regulatory Affairs consultant is and what traits and attributes you will want to see in the person or consultant you hire.

 

Hire a Regulatory Consultant Early

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.

New Drug Submission Process

NEW DRUG SUBMISSION PROCESS

 

In Canada, as in all countries with regulatory agencies, there are specific regulatory pathways and processes for health products to be authorized for use in clinical trials or to obtain marketing approval. If you are looking to conduct a clinical trial or submit for the marketing authorization of a new health product, it is important to be familiar with the new drug submission process in Canada and what other regulatory processes look like, including the pathways that are available to you to achieve this.  

 

Drug Regulatory affairs 

Regulatory affairs in relation to clinical trials or investigational testing refers to the process of ensuring that a trial conducted with patients or healthy individuals adheres to all relevant laws and regulations during the drug, medical device, or other health product clinical development process. This includes getting necessary authorizations from regulatory agencies governing the country where the sponsors wish to launch a trial.

In Canada, that regulatory agency is Health Canada (HC). The goal of HC, its Food and Drug Regulations, and regulatory processes is to protect the health and safety of the participants in those trials and ensure the accuracy and integrity of the data collected; this includes the reporting of any serious adverse events that occur during the studies. HC is interested not only in the safety of trial participants; data accuracy and integrity are as important and are needed for the eventual market access application you will submit at the end of the clinical development process.

Most countries have their own regulating body, for example, the Food and Drug Administration (FDA) in the United States (US), European Medicines Agency (EMA) in the European Union, Therapeutic Goods Administration (TGA) in Australia and the Central Drugs Standard Control Organization (CDSCO) in India, to name a few.

What they have in common is that the approach to trials, drug development, and market access process be transparent and efficient whilst ensuring the safety, efficacy, and quality of the product for their citizens.

 

Regulatory and licensing pathways

In Canada, Health Canada has various licensing pathways for drugs, medical devices and other health products and they continue to work towards different pathways to facilitate market access of key health products, particularly those for unmet medical needs.

The regulatory strategies and submission work are done by regulatory experts; professionals well-versed and experienced in how each regulatory body evaluates and approves New Drug Submissions (NDS), Medical Devices License Applications as well as other health product applications in Canada or their equivalent outside Canada.

Specifically, the drug approval pathways in Canada are summarized as follows:

Regular New Drug Submission Process:

New Drug Submission is the regulatory process required by Health Canada that pharmaceutical companies are required to go through to bring their new drugs to the market. The submission must include all relevant data and information about the drug, including non-clinical, clinical, and quality data, which address safety and efficacy as well as the overall quality (chemistry, manufacturing, and controls) of that drug. Health Canada reviews this information to determine if the drug is of good quality, safe and effective (positive benefit vs. risk ratio) for its intended use. Only then can it be approved for sale to the public.

The standard timeframe for scientific review of the NDS is 300 days, preceded by a screening period of 45 days and 10 days of technical processing, as indicated below:

 

New Drug Submission Process in Canada

 

Priority Review New Drug Submission Process

A Priority Review (PR) New Drug Submission (NDS) is a type of regulatory filing submitted to Health Canada for the review of a new drug, at the end of its clinical development program, that is considered to have the potential to provide significant benefit over existing therapies (when available) for serious or life-threatening conditions. PR NDSs are prioritized over standard NDSs and are scientifically reviewed within 180 days, rather than the standard review time of 300 days. This expedited review process is intended to help bring new, innovative treatments to patients in need more quickly.

To apply for a Priority Review NDS, a sponsor must demonstrate that the drug is to be used for a serious, life-threatening, or severely debilitating condition when there is substantial evidence of clinical effectiveness that shows the following:

  • effective treatment, prevention or diagnosis of a disease, for which no therapy is available in Canada, or
  • significant increase of efficacy and/or decrease in risk, supporting an improved benefit/risk profile over available treatment, prevention, or diagnostic agent for a disease, not adequately managed by available agents in Canada.

In summary, Priority Review New Drug Submission Process in Canada allows for drugs with a complete clinical program that address important unmet medical needs. The sponsor has to apply for a PR through an official request supported by a Clinical Assessment Package, justifying scientifically and with sufficient data why the submission should be granted PR rather than following the standard NDS process.

The Priority Review process differs from the regular NDS process as presented below:

New Drug Submission Process in Canada with Priority Review

Notice of Compliance with Conditions – NOC/c NDS:

The Notice of Compliance with Conditions (NOC/c) pathway allows a sponsor to bring a new drug to market during the clinical development process, and therefore more quickly, in exchange for accepting to complete the clinical development program agreed to with Health Canada. An approval under the NOC/c policy contains conditions that a sponsor needs to comply with after the drug approval.

Eligibility

Eligibility for advanced consideration for a NOC/c applies to NDSs and SNDSs for serious, life-threatening, or severely debilitating conditions when there is promising evidence of clinical effectiveness based on the available data that shows the following:

  • effective treatment, prevention, or diagnosis of a disease, for which no therapy is available in Canada, or
  • significant increase of efficacy and/or decrease in risk, supporting an improved benefit/risk profile over available treatment, prevention, or diagnostic agent for a disease, not adequately managed by available agents in Canada.

NOC/cs are possible for drugs with promising clinical data that addresses important unmet medical needs. The NOC/c process differs from the regular NDS process as presented below:

New Drug Submission Process in Canada -NOC with Conditions

Drug Submissions Relying on Third-Party Data (Literature and Market Experience):

This refers to the use of existing scientific literature or third party published data in lieu of clinical study reports to support the safety and efficacy of a drug. Literature can be used to support a New Drug Submission (NDS) or a Supplemental New Drug Submissions (SNDS) in Canada.

This approach saves time and resources for both the sponsor and HC, provided that the submission complies with the criteria established by HC. The literature must be relevant, reliable, and adequate to support the safety and efficacy of the drug in question and meet current regulations, guidelines and recommendations. The chemistry, manufacturing and controls (quality) data requirements are the same as for any other NDSs or SNDSs.

In addition to the pathways summarized above, HC does explore additional pathways to facilitate drug development to address unmet medical needs and to streamline their own processes, for example: Australia-Canada-Singapore-Switzerland (ACSS) Consortium and use of foreign reviews and decisions.

Project Orbis is another example of an international partnership HC is a part of which is designed to give cancer patients faster access to promising cancer treatments, alongside the US FDA. Products eligible for Project Orbis include oncology products that are either new active substances or new indications for previously approved drugs. Project Orbis submissions are expected to meet the criteria for “FDA Priority Review” and Health Canada PR or NOC/c criteria.

The various programs or pathways presented above can be explored with the assistance of regulatory experts, when a sponsor wishes to obtain a marketing authorization for a new drug in Canada. The various submission types have to respect specific criteria established by HC, which further underscores the need to work with regulatory experts that can orient the sponsor towards the most relevant and efficient pathway to use.

After the Notice of Compliance – NOC

Once Health has reviewed the submission and determined that the drug is safe and effective for its population, they will issue a Notice of Compliance (NOC), which grants the sponsor permission to sell the drug in Canada.

After an NOC has been granted for a new drug in Canada, maintaining the drug on the market requires various compliance activities, including pharmacovigilance and lifecycle management to ensure that the drug continues to be compliant with the requirements of the Food and Drug Regulations. Life cycle management activities could include a Supplemental New Drug Submission with new data from clinical trials to support a new indication or other important changes to the labelling of the drug. Likewise, major changes to the manufacturing process, or adding new formulations or a new dosage form, for example, would also require a submission to HC to ensure compliance with the regulations. For major changes that require approval from HC, a new NOC will be issued once HC has reviewed the submission and supporting data and, determined that the changes are acceptable; only then these changes can be implemented.

The Role of Regulatory Experts

Whichever pathway you utilize, it is imperative that the approach be one that is streamlined, transparent, and efficient, while ensuring the quality, safety, and efficacy of the product. It is the role of regulatory experts to strategize with you about which pathway to follow, and to navigate these applications through HC or their equivalent outside of Canada, to liaise with regulatory body officials, and lead the submission process.

For further information about the drug review process, please contact SPharm directly.

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Top Traits of Drug Regulatory Affairs Consultants

Overcoming Obstacles in the Drug Approval Process

Does Health Canada give approvals based on foreign decisions?

Overcoming Obstacles in the Drug Approval Process

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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Does Health Canada give approvals based on foreign decisions?

Does Health Canada give approvals based on foreign decisions?

 

 

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

This is a major miss-conception. We 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.

 

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

 

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.

Are Sponsors required to have a legal representative reside in Canada?

 

Does Health Canada require Sponsors to have a legal representative reside in Canada?

 

 

DOES HEALTH CANADA REQUIRE SPONSORS TO HAVE A LEGAL REPRESENTATIVE RESIDE IN CANADA?

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.

With respect to having Sponsors having a legal representative residing in Canada for the Registration Process, the answer is no, Health Canada does not require Canadian residence. Nonetheless, if the sponsor is not located in Canada, a Canadian importer must be determined and their Drug Establishment License (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 and being in the same time zone as the reviewing regulatory agency.

 

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

 

How to Pick a Drug Regulatory Affairs Consultant

HOW TO PICK THE RIGHT DRUG REGULATORY AFFAIRS CONSULTANT

“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 “right” drug regulatory affairs consultant.

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 expert, consultant, expert or 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 consultants, experts or professionals (or other names you call them) 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 drug regulatory expert or consultant or an outside regulatory 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.

 

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.

Can SPharm Help?

If you are looking for help navigating the drug approval process in Canada or the medical device approval process in Canada, or assistance with clinical trial applications or new drug submissions, then perhaps reaching out to SPharm experts may be worthwhile. 

Celebrating 25 year anniversary in Regulatory Affairs

Press release celebrating 25 year anniversary in Regulatory Affairs. SPharm – Canada’s Drug Regulatory Experts.

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Does Health Canada require all documents be translated to French?

 

Does Health Canada require that all documents be translated to French?

 

 

DOES HEALTH CANADA REQUIRE THAT ALL DOCUMENTS 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.

 

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

 

Notice of Compliance with Conditions versus Priority Review

What is the difference between Notice of Compliance with Conditions and Priority Review?

 

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.

  

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