Category: Uncategorized

FDA Harmonization

Posted on by Brandon Miller

The FDA harmonization team has recently announced it is no longer going to be a member of the Global Harmonization Working Party (GHWP). This comes as an eye-opener for many life science industry employees since FDA harmonization has been a visible priority since the agency joined GHWP in 2021.

 

The FDA stated that it will continue to work with global regulatory experts on international harmonization, with the primary partner being the International Medical Device Regulators Forum (IMDRF).

 

Food and Drug Administration

 

Some industry executives have asked the question why take this type of action now? One primary reason many life science industry experts believe the time is right is based on the Center for Devices and Radiological Health (CDRH) strategic plan launched in late 2023. Inside the details of the document, the Food and Drug authority laid out a four-year example timeline for working towards greater international harmonization.

 

These are a few of the initiatives listed to be achieved by FY 2027:

 

FDA Timeline

 

Each fiscal year, CDRH will now evaluate different types of opportunities to increase engagement across international harmonization programs. Further, it is anticipated that CDRH will receive additional funding and resources to help accelerate this engagement. These additional resources will be designed to allow the FDA to expand international harmonization and convergence programs already in progress. 

 

Best Practices

 

The second phase of the strategic plan is designed to increase discussions about the implementation of harmonized policies. Further, this new mechanism may require FDA to develop additional confidentiality agreements to increase the efficiency of research analysis & discussion under confidentiality commitments. CDRH will review the current list of approved regulatory partners and confidentiality protocols in place to align regulatory strategies across international agencies. 

 

Medical Research

 

Per the strategic plan, FDA will identify and begin engaging with regulatory authorities by the end of 2023. The primary objective is to create a database of regulatory bodies with whom sharing medical research could be most helpful toward the global harmonization of standards. Finally, CDRH has committed to creating this information-sharing mechanism to communicate best practices in medical device evaluation by the end of 2024. 

 

Technical Documents

 

The strategic plan goes on to elaborate on how CDRH’s regulatory policy compares to widely accepted IMDRF policies. Furthermore, technical specifications of IMDRF documents that include policies and practices approved by all regulatory authorities in the IMDRF Management Committee will be assessed and evaluated by FDA.

 

One goal of this regulatory process is to increase the understanding of technical description and technical report writing of international regulatory agencies. This will directly help CDRH with their internal assessment of international harmonization efforts, and how FDA’s process may differ in comparison to regulators around the world.

 

FDA Analysis

 

Based on the technical specification data listed in the strategic plan, these are the proposed timelines for CDRH to make advances toward global harmonization:

 

  • CDRH will publish an assessment of at least nine IMDRF technical documents by the end of 2025.
  • CDRH will publish an assessment of at least 18 IMDRF technical documents by the end of FY 2026.
  • CDRH will publish an assessment of all remaining IMDRF technical documents by the end of FY 2027

 

Regulatory Authority

 

The strategic plan continues to elaborate on the life science community and the impact non-FDA employees can have on future regulatory approval. These specific stakeholders may have a unique perspective based on their current occupation or the types of therapy a patient receives. Finally, the following audiences are specifically mentioned for providing first-hand experiences that FDA can leverage based on another regulatory authority’s approach to medical therapy. 

 

  • Healthcare patients
  • Life science manufacturers
  • Conformity assessment bodies
  • Standards development organizations

 

Patient Engagement

 

Finally, an annual communication plan is proposed to begin in 2024 that includes developing a forum to assess and report on harmonization program efforts in progress. This forum will be designed to connect with each of the audiences mentioned above to help FDA identify opportunities for learning. Furthermore, this forum would be dependent on the level of interest and considerations of other stakeholders, including the life sciences industry specifically. 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Quality Assurance Services

Posted on by Brandon Miller

About RCA’s Quality Assurance Services

In the life science industry, quality assurance (QA) is more than merely ensuring the quality of a finished product. You need the tools to monitor and regulate every process from the design of a new product to continued quality compliance as the device or drug is sent to market. At Regulatory Compliance Associates (RCA), we offer you the quality assurance services you need to monitor these quality processes and ensure quality compliance every step of the way.

 

RCA’s quality assurance services include quality system assessments, strategy, implementations, and identification of quality metrics. Our quality consultant projects are designed to ensure continuous improvement and align with your business needs & goals. Our quality consultants are quality experts with experience spanning major corporations and start-ups. Our quality management consultant team knows firsthand how to achieve, maintain, and improve quality, and we excel in transferring this knowledge to your organization.

 

Follow the links below to learn more about our quality assurance services in Pharmaceuticals and Medical Devices. 

 

Pharmaceuticals

Medical Device

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Pharmaceutical Supply Chain Consulting

Posted on by Brandon Miller

RCA Pharmaceutical Supply Chain Consulting Services

 

The best way to maintain healthy business practices and get ready for an FDA audit is through training and preparation. Training employees and executives throughout your organization can lead to improved data storage and a better understanding of why proper storage is so essential for your business. Our services can help you maintain quality compliance within all aspects of your business, from design and manufacturing to packaging and distribution. These services include:

 

Assessments 

 

The best thing you can do to avoid a compliance crisis is to take preventive measures that will locate and remedy any outstanding issues. At RCA® Inc., our pharmaceutical supply chain consulting experts have decades of experience in both regulatory compliance program strategy and execution. RCA’s healthcare consulting Experts will help you measure your quality system based on global regulatory markets to assess any process weaknesses and opportunities to improve.

 

Our range of compliance consulting services includes:

 

  • cGMP & Pharmaceutical Manufacturing
  • Quality Infrastructure
  • PAI, Validation
  • Facilities and Maintenance
  • Laboratory (GLP)
  • Process Assessments to Streamline and Optimize New and Existing Systems.

 

Audits 

 

Periodic regulatory audits are necessary to ensure the continued compliance of your organization. An internal audit from a pharmaceutical supply chain consulting 3rd party can help your perspective when it comes to a regulatory audit. Our experienced team of ASQ-CQA and RABQSA-certified auditors is available to perform a range of internal audit services, including:

 

  • Supplier
  • API
  • Contact Manufactures (CMO)
  • Internal
  • Quality Systems
  • Baseline
  • Verification
  • Clinical (CRO) and Clinical Manufacturing
  • Data Integrity
  • 503A & 503B
  • Combination Products

 

Regulatory Agency Response 

 

Unfortunately, compliance crises do happen, and they can have a lasting impact on your business if you are unintentionally caught off guard. Regulatory Compliance Associates pharmaceutical supply chain consulting Experts can assist you in developing a customized response & plan of action to help remediate the effects of a regulatory warning letter. Our compliance and regulatory services team is here to provide the technical consultant guidance you need most during this time, with response solutions for:

 

  • FDA Form 483
  • Warning Letter
  • Consent Decree
  • Import Bans

 

Preparation, Training, and Inspection Readiness 

 

Sitting back and hoping for your next regulatory inspection to go well isn’t an option — you need to comply with regulations and actively prepare. RCA® will help you thoroughly prepare for inspections with an extensive range of business consulting services, mock inspections, and other medical consulting readiness solutions:

 

  • Mock Inspections
    • Back Room/ Front Room set-up and process
    • Inspection Analysis & Report
  • Response Letter Assistance
  • Proof Book Development
  • Business Relations (Leadership Development Training)
    • Corporate Regulation Examples
      • Regulatory Law
      • Regulatory Board
      • Legal Compliance
  • Industry Relations (Leadership Development Training)
    • Types of Regulation
      • Medical Regulations
      • Security Regulations
      • Cybersecurity Regulations
      • Data Compliance Regulations

 

Data Integrity

 

Training:

 

  • Good Documentation Practices (GDP) Centered on How the Data is Recorded, How to Correct an Error, and How to Document the Reason(s) for the Error
  • Annual Good Manufacturing Practice (GMP)
  • Investigations
  • Corrective Action and Preventive Action (CAPA)

 

Consulting:

 

  • Comprehensive Audits
  • Development of a Remediation Plan to Address any Risks and Weaknesses Identified During the Audit
  • Assistance with Execution of the Remediation Plan

 

In the event of an audit, the information gathered during the manufacturing of pharmaceuticals—from its raw stages through launch and everything in between—will be used to defend the product’s use once it’s been released for patient use.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Post Market Surveillance

Posted on by Brandon Miller

The U.S. Government Accountability Office (GAO) publishes independent audits at the request of consumer advocates, watchdog groups, and members of the United States Congress. One of the most recent publications involved the U.S. Food and Drug Administration (FDA) post market surveillance process, including an analysis of management & oversight across agency functions and employees.

 

 

Additionally, the post marketing study uncovered hurdles FDA encountered during the medical device audit. The final 27-page report included feedback on whether the agency was efficient while handling problems and protecting data integrity. These details offer a snapshot of how a regulatory body operates in real time across the life science industry, and where efficiency could be examined.

 

What is a Post Market Surveillance System?

 

The U.S. Food and Drug Administration (FDA) has an approved regulatory framework & database (MAUDE) designed to connect consumer complaints and compliance adverse events to a product code and medical device manufacturer. This post market surveillance system (PMS) is a validated FDA regulatory process designed to increase transparency and continuous improvement.

 

Adverse Events

 

A post market surveillance system is the market listening mechanism between real world evidence and analysis. Software platforms are used as a global harmonization resource for monitoring adverse events (e.g. poisoning, adverse reaction) across countries, devices & the cycle of patient life.

 

 

Additionally, the post market surveillance system is designed to help collect HIPAA-compliant patient data & medical device product ID info in a single source of postmarket truth. Patent-generated evidence (e.g. FitBit, Apple Watch) is a growing data source HCPs recognize at the point of care which medical device manufacturers could use during product design & commercialization.

 

Patient Safety

 

Additionally, the post marketing surveillance process uses incoming data to search for patient safety trends proactively. The future may include post marketing requirements that help educate the population’s health, and when label changes should be communicated to consumers. Finally, when a negative safety trend begins to accelerate, FDA may consider if the marketing approval of the product should be removed.

 

What is a Unique Device Identifier (UDI)?

 

The unique device identification (UDI) is an exclusive code related to a specific medical device. Each UDI promotes a transparent identification system that helps life science employees trace a product using a numerical & alphabetical format on the device label. Each unique device identification number includes a mix of production and device identifier (DI) data based on the manufacturing process. Further, the elements of the production identifier (PI) portion of the UDI code include this information on each device label:

 

  • Manufacturing date
  • Manufacturing batch number (or lot number)
  • Device serial number
  • Device expiration date
  • Distinct identification code (for combination products)

 

FDA mandates that any patient documentation needed to uncover the root cause of a medical device’s problem be included in the safety profile risk analysis. Ideally, the risk analysis would also contain information from a patient’s EHR health records and/or the payer’s claim data or pharmacy data. Both of these are widely considered reliable post market surveillance data sources.

 

A full transcript and highlights of the GAO report can be found here. 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Cannabis Business Success

Posted on by Brandon Miller

The cannabis consulting market is moving very quickly to support new businesses and many competitors are seeking the consumer’s attention. Right now, there’s no doubt that CBD-based products are getting plenty of attention. Gummy bears and other edibles are making the news, and the media is filled with stories about the powers of CBD oil.

 

At the same time, there are increasing calls for cannabis regulation from federal and state agencies as well as consumer groups. How can you ensure customers find you, and how can you grow your own successful business? The following cannabis consulting tips can help:

 

  • Know the rules: You cannot be successful if regulatory agencies shut you down or discredit your business model. If you manufacture or market CBD products, familiarize yourself with Current Good Manufacturing Practice (CGMP) regulations, state laws and FDA rules. A cannabis consulting expert can help you determine if the product is a supplement or drug, and follow the general guidelines for that type of product.
  • Offer quality and consistency: Create systems to ensure your products are consistent. Avoid switching vendors, suppliers and partners to allow you to develop a product you can stand behind. A cannabis consulting firm can leverage testing to prove the quality and maintain control of the manufacturing process.
  • Keep it real: Only advertise or market product benefits if you have hard data for that product. The FDA and other agencies have been sending warning letters for non-compliance to CBD and related businesses based on marketing alone. Even if you are creating a quality product, you need to make sure you can stand behind every word of your marketing. Stay consistent in branding and keep providing quality to your customers.
  • Get ready for regulations: Even if you are successful today, you need to stay agile for the upcoming regulatory changes. Keep alert to changes in state bills and new rules created at the federal level. Start documenting and testing now and invest in processes that back up your product. The more transparent and data-focused you can afford to be, the more prepared you may be for coming law changes.
  • Focus on customers: Customers are getting plenty of contrary information about cannabis and CBD. They may hear about the beneficial properties of these products, but they may also be hearing warnings from other sources. Consider how confusing this may be and offer quality information and reassurance about your products, backed up by testing so customers know they can trust you. Arm your audience with the information they need to buy from you.

 

Pave the Road for Cannabis Success

 

Do you need a partner for your business success? Regulatory Compliance Associates helps companies just like yours stay compliant. We help you address regulatory and quality issues and allow you to focus on growth while we stay on top of regulatory and FDA changes. Contact us at Regulatory Compliance Associates to learn what we can do for you.

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].

Data Anonymization

Posted on by Brandon Miller

A recent update for Health Canada and EMA’s data anonymization program included instructions for filling out the new clinical template and a more granular look inside the harmonized Anonymization Report (AnR). Further, the goal of this regulatory harmonization program is to make EU and Health Canada identification of specific patients from characteristics in the data set as highly unlikely as possible.

 

What is Data Anonymization?

 

Data anonymization is a method for presenting research data in a way that reduces our ability to identify the individuals who participated in the clinical study. Best practices for Clinical anonymization commonly target how to protect the trial participant’s data and clinical trial drivers, such as:

 

  • Device manufacturer
  • Drug manufacturer
  • Device trade name
  • Drug trade name

 

Patient data and re-identification can also be linked to outlier conditions to be considered:

 

  • Protocol design vs. advanced methods
  • Special populations
    • Rare disease state
    • Ultra rare disease state

 

Finally, consideration must be given to small trial populations that can limit the intended scope of patient disclosure. For example, since there are fewer patients in the trial, any form of incomplete anonymization often leads to an increased risk of re-identifying a trial participant.

 

Regulatory Compliance

 

Two unique regulatory standards are being used as guidance for drug sponsors & data anonymization clinical teams:

 

  • Health Canada
    • Public Release of Clinical Information (PRCI)
  • EMA
    • Policy 0070 Clinical Data Publication (CDP)

 

Finally, an important benefit of anonymization is the ability to proactively distribute scientific data to reduce duplicate clinical trials. Building public trust in products coming to market is often accomplished by increasing the awareness of clinical successes. The healthcare industry’s ability to scrutinize the data against both standards to be durable, reliable, and anonymized over time will help researchers improve clinical outcomes.

 

Drug Sponsors

 

The regulatory process will now include drug sponsors submitting only one anonymization report for both Health Canada and EMA regulatory submissions. The updated report format for both Health Canada and EMA uses a mix of predefined, multi-choice questions and verbatim response questions. Additionally, the format is optimized for clinical data sharing between each regulatory body to improve transparency and product efficacy. 

 

A drug sponsor’s anonymization methodology would include a risk assessment that shows either a qualitative or quantitative calculation (or a combination based on clinical strategy). Redacted copy options include both Personal Information that satisfies Health Canada regulatory and Protected Personal Data for the EMA regulatory format. Finally, direct identifiers of both the clinical report signatory and principal investigator should be listed with the rationale for each clinical approach used.

 

Adverse Events (AEs)

 

Indirect identifiers are anonymization report categories often about clinical data specifically related to the trial (or product used in the clinical trial). This information is not enough to stand on its own in terms of independent study variables. Instead, the data analysis is dependent on the clinical trial to connect the differences between patient information and an actual participant.

 

All adverse events (and terms related to the adverse event) should be recorded in these formats:

 

  • Summary level
    • Tables and/or descriptive summaries
  • Participant level
    • Written patient narrative based on AEs

 

Special Populations

 

Select clinical trial participants may fall under the anonymization category of special populations. These participants often include a sub-set audience that is impacted by either the patient’s life events or stage of life while participating in the clinical trial. Special populations often warrant a different level of clinical segmentation that should be documented and analyzed in the final reporting submission.

 

Further, their current health condition may warrant creating a clinical subset of participants for regulatory approval, such as:

 

  • Trial specific examples:
    • Pediatric
    • Geriatric
  • Patient specific examples:
    • Pregnant women
    • Breastfeeding women.

 

In the context of anonymization, these special populations may need a unique reporting strategy since they often do not share all key characteristics of the trial population.

 

 

To begin the Regulatory Compliance Associates scoping process today, please enter your information in the blue form below and click the submit button at the bottom of the webpage. You may also email us at [email protected].