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.

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.