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Commercial Eyes Recruiting: Regulatory Services Professional

Recruiting: Regulatory Services Professional

Commercial Eyes has a great opportunity for a Regulatory Services Professional

Operating within the Regulatory Services Business Unit at Commercial Eyes, and reporting to the Regulatory Services Manager or Director, this role will involve the provision of both technical support and project management support to the Regulatory Services team, with the focus weighted to either a Senior Consultant or Project Leader role, depending on the successful candidate.

 

To be successful in this role you will:

  • Have a strong understanding of the broader health technology sector, the regulatory and reimbursement environment, business and commercialisation strategies.
  • Take responsibility for individual tasks and projects, and work closely with client teams.
  • Have rigorous analytical skills, integrity, and the ability to handle the challenges inherent to the commercialisation process.
  • Be excited about delivering substantial and lasting change to our clients’ businesses, and enjoy brainstorming potential issues and their solutions.
  • Be relaxed and confident when communicating with clients.
  • And, importantly, be comfortable with ambiguity – seeing it as an opportunity to generate insights.

 

As a Regulatory Services Professional, you will be responsible for…

  • Providing strategic advice to clients regarding the Australian and New Zealand regulatory environments.
  • Providing support to clients on the registration and listing of pharmaceuticals and medical devices in Australia and New Zealand.
  • Reviewing, critically evaluating, preparing and/or submitting regulatory dossiers to the TGA and Medsafe.
  • Assisting senior team members in the preparation of literature based submissions, including the preparation of associated overviews and summaries.
  • Assisting clients in responding to agency questions.
  • Assisting clients with the maintenance of current registrations and listings.
  • Attending meetings/teleconferences with clients and/or TGA or Medsafe, as required.
  • Building strong interpersonal networks across the life sciences sector and drawing on these to identify potential short and long-term business opportunities for Commercial Eyes.
  • Liaising with other groups within Commercial Eyes as required.
  • Mentoring junior staff as required.

 

Become part of our vision and in return…

We provide employees at all levels with challenging work from diverse clients within the life sciences sector, and each individual has the opportunity to continually learn and grow.

The opportunity is a rewarding one that offers all the traditional benefits of employment, such as competitive salary, a supportive & respectful culture and a pleasant work environment, as well as a strong sense of teamwork, job satisfaction and achievement.

By joining Commercial Eyes, you will be able to expand your professional network within the industry whilst working in a well-known professional services organisation that recognises talent and expertise.

 

Agencies please note: this recruitment assignment is being managed directly by the Commercial Eyes HR team. We will contact our preferred agency partners in the rare instance we require additional talent options. Your respect for this process is appreciated.

For more information about this role, please visit our Seek Ad.

Please contact Jeanette Lodge on 03 9251 0777 if you have queries about the role that have not been addressed in the job ad.




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Commercial Eyes Recruiting: Medical Information Professional

Recruiting: Health Economist

Commercial Eyes has a great opportunity for a Medical Information professional

to join our Medical Information team on a full-time basis. The ideal candidate will have prior experience in the provision of scientific information and the report of spontaneous adverse events and product complaints in a pharmaceutical company or hospital setting.

 

To be successful in this role, you will have…

  • Excellent verbal reasoning and written communication skills
  • Highly developed time management, problem solving and project management skills
  • Proficient in building productive relationships and networks
  • A keen interest in the practice of consulting

 

Key responsibilities include:

  • Handle and disseminate technical and scientific information in a timely manner in response to enquiries received from healthcare professionals and patients, as well as internal business units, regarding relevant client’s products
  • Assist in maintenance (creation, review and approval) of standard responses in the medical information database
  • Respond to customer queries using various research strategies, including performing literature reviews
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities
  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures
  • Abide by relevant client requirements and country regulations in respect to managing customer complaints, adverse events and handling of enquiries
  • Adhere to company and regulatory requirements, as well as voluntary codes of practice

 

In Return…

This role is a rewarding one that offers all the traditional benefits of employment, such as competitive salary, a supportive & respectful culture and a pleasant work environment, as well as a strong sense of teamwork, job satisfaction and achievement.

By joining Commercial Eyes, you will be able to expand your professional network within the industry whilst working in a well-known professional services organisation that recognises talent and expertise.

 

Applications from recruitment agencies will not be considered.

 

For more information about this role, please visit our Seek Ad.

Please contact Lorenza Ricacho on 03 9251 0777 if you have queries about the role that have not been addressed in the job ad




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Commercial Eyes Recruiting: Health Economist

Recruiting: Health Economist

Commercial Eyes has a Unique and Exciting Opportunity for a Health Economist

This role is pivotal to enhancing our comprehensive and competitive pricing and reimbursement practice. The primary focus of the role is to provide high quality technical health economic and statistical input for a diverse range of projects including feasibility assessments, reimbursement strategy development and funding submission development (PBAC, MSAC, NBA, PLAC, PHARMAC).

Critical to this role is the ability to demonstrate pragmatism, integrity, collaboration in a team environment and confidence when liaising with clients to deliver customer-focussed outcomes according to agreed deadlines and client requirements.

 

To be successful in this role you will ideally possess:

  • Undergraduate tertiary qualifications in economics or a life sciences discipline;
  • Post-graduate qualifications in health economics, epidemiology, statistics, or health sciences;
  • A thorough understanding of statistics and health economic modelling methodologies;
  • Advanced skills with modelling software, in particular MS Excel;
  • Excellent numerical and analytical skills demonstrated in an appropriate professional setting (industry, academic, government);
  • Attention to detail and ability to produce work of consistently high quality;
  • A strong understanding of the Australian health care market and funding mechanisms;
  • A keen interest in the practice of consulting.

 

The rewards…

Our consultants draw on significant accrued experience and know-how gained from the exposure that comes with being part of a highly regarded consultancy that offers a full suite of commercialisation services. The Market Access team consists of industry specialists with a practical and thorough understanding of the challenges to market access in Australia and New Zealand, and appreciate the importance of a holistic approach backed by sound technical capability.

 

For more information about this role, please visit our LinkedIn Ad.

Please contact Tenille Manuele on 03 9251 0777 for a confidential discussion or to request a copy of the Position Description.




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Commercial Eyes Recruiting: Market Access Professional

Regulatory Services Manager

Commercial Eyes has a great opportunity for a Market Access Professional

to join our established Market Access team in the capacity of Senior Consultant or Consultant. These roles are pivotal to enhancing our comprehensive and competitive pricing and reimbursement practice through the provision of technically sound strategic advice, feasibility assessment, health economics activities and funding submission development.

 

To be successful in this role, you will ideally possess…

  • Undergraduate tertiary qualifications in economics or a life sciences discipline and/or;
  • Post-graduate qualifications in health economics, epidemiology, statistics, or health sciences;
  • Commercial life sciences experience in health outcomes, market access, health economics or a related discipline;
  • Knowledge of the Australian and New Zealand healthcare landscapes, particularly the reimbursement environment and processes (PBAC, MSAC, PLAC, NBA and/or PHARMAC);
  • Excellent verbal reasoning, written communication and project management skills;
  • Previous consultancy experience or a keen interest in the practice of consulting;
  • Experience in negotiating with key Government stakeholders and/or pricing experience will be highly regarded.

 

Critical to these roles is the ability to demonstrate pragmatism, integrity, collaboration in a team environment and confidence when liaising with clients to deliver customer-focussed outcomes according to agreed deadlines and client requirements.

 

The rewards…

Our consultants draw on significant accrued experience and know-how gained from the exposure that comes with being part of a highly regarded consultancy that offers a full suite of commercialisation services. The Market Access team consists of industry specialists with a practical and thorough understanding of the challenges to market access in Australia and New Zealand, and appreciate the importance of a holistic approach backed by sound technical capability.

 

To apply, please submit your CV and cover letter via the Seek Job Ad.

Please contact Tenille Manuele on 03 9251 0777 for a confidential discussion or to request a copy of the Position Description.




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Commercial Eyes Recruiting: Medical Information Associate

Regulatory Services Manager

Commercial Eyes has a great opportunity for a Medical Information Professional

to join our Medical Information team on a fixed term 6-month contract. The ideal candidate will have prior experience in the provision of scientific information and the report of spontaneous adverse events and product complaints in a pharmaceutical company or hospital setting.

 

To be successful in this role, you will have…

  • Excellent verbal reasoning and written communication skills.
  • Highly developed time management, problem solving and project management skills.
  • Proficient in building productive relationships and networks.
  • A keen interest in the practice of consulting.

 

Key responsibilities include:

  • Handle and disseminate technical and scientific information in a timely manner in response to enquiries received from healthcare professionals and patients, as well as internal business units, regarding relevant client’s products
  • Assist in maintenance (creation, review and approval) of standard responses in the medical information database
  • Respond to customer queries using various research strategies, including performing literature reviews
  • Maintain professional knowledge and accreditation by active participation in continuing medical education activities
  • Ensure that all potential adverse events or product complaints are appropriately reported and followed-up according to client procedures
  • Abide by relevant client requirements and country regulations in respect to managing customer complaints, adverse events and handling of enquiries
  • Adhere to company and regulatory requirements, as well as voluntary codes of practice

 

In return….

This role is a rewarding one that offers all the traditional benefits of employment, such as competitive salary, a supportive & respectful culture and a pleasant work environment, as well as a strong sense of teamwork, job satisfaction and achievement. 

By joining Commercial Eyes, you will be able to expand your professional network within the industry whilst working in a well-known professional services organisation that recognises talent and expertise. 

 

For more information about this role, please visit our Seek ad.

Please contact Lorenza Ricacho on 03 9251 0777 if you have queries about the role that have not been addressed in the job ad. 




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TGA Inspections are Coming – Is your Company Ready?

TGA Inspections

The TGA has recently concluded its pilot program in Pharmacovigilance inspections in Australia.  Numerous companies volunteered to take part in this inspection program, and from those volunteers the TGA selected ten companies.  The selection process by the TGA considered a) the type of company and b) the products of these companies.  The TGA tried to include a comprehensive group of organisations (including large multinationals, generics companies, complementary/herbal medicine companies, smaller biotechnology companies, and Australian owned and based companies) with the view that the inspections would encompass an extensive portfolio of medicines (registered, listed, OTC, complementary, vaccines, innovative, generic, topical, oral, nasal, IV, those with and without RMPs/PSURs).

The inspection process itself was similar to those inspections conducted by other Competent Authorities such as the MHRA, in that the process was divided into pre-inspection phase, inspection phase, and post-inspection phase.

  1. Pre-Inspection – 1 month prior to inspections, a draft agenda and initial document request were sent to the companies.
  2. Inspection – consisted of opening meeting, interview sessions (to gain understanding of PV processes), document requests (to allow the inspectors to verify statements in the interviews), review of documents, and a closing meeting (verbal overview of findings)
  3. Post-Inspection – 4 weeks following the receipt of the last document sent by each company to the TGA, a formal inspection report was provided to the company. The companies were given 4 weeks to respond to the findings (using a CAPA plan to record the findings, then carry out any necessary actions), the proposed CAPAs were assessed by the inspectors (changes and/or additions negotiated between the TGA and company), and the inspection process was deemed to be closed.

The TGA Inspectors considered the following during their inspections: ADR collection and processing, processes for ongoing monitoring of safety, PSUR production and co-ordination, maintenance of RSI, the Australian RPPV, and relevant Australian PV legislation and guidelines.

The formal inspection report graded the deficiencies as either

  • Critical – deficiencies in the PV practice or processes of the company that already have or may significantly and adversely affect the safety or well-being of patients or that poses a potential risk to public health or that represents a serious violation of applicable legislation and guidelines.
  • Major – deficiencies in the PV practice or processes of the company that could potentially adversely affect the safety or well-being of patients or that could pose a potential risk to public health or that represents a significant violation of applicable legislation and guidelines.
  • Other – a deficiency that cannot be classified as either critical or major, but indicates a departure from good pharmacovigilance practice. These deficiencies are not deemed to be expected to adversely affect the safety or well-being of patients.  It may be a deficiency which has been judged as minor, or because there is insufficient information to classify it as major or critical.

The pilot program demonstrated that the majority of findings were in the following areas:

  • Australian RPPV roles and responsibilities,
  • Deficiencies in procedural documentation,
  • Ongoing monitoring processes,
  • Submission of PSURs (deviation from the PSUR submission schedule),
  • Significant safety issues communication (late communication to the TGA),
  • Maintenance of RSI (delays in updating Australian product information, delays in updating CMI documents), and
  • AE case collection and processing (late/non-submission to the TGA, non-conservative seriousness assessments, lack of due diligence in identification of AEs and special situation reports, deficiencies in PV contracts and training of vendors)

Since the purpose of the pilot program was for the TGA to characterise how they consider is the best way to progress with inspections in the future.  The volunteering companies were asked to fill out a questionnaire, and responses have been useful and given the TGA further points to consider.  Points such as challenges with time zone differences were raised.

The TGA are in the process of determining whether a national PV inspection program is feasible, and the industry should hear more information via a consultative process shortly.

 

Please contact our expert Pharmacovigilance team on +61 3 9251 0777 for assistance in making sure you are ready for those inspections

This article was written by Beverley Worrall, from our Pharmacovigilance team




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What is food for special medical purposes (FSMP)?

Food for Special Medical Purposes

With a greater recognition of the importance of nutritional support in medical therapy and improved technology, the “food for special medical purposes” (FSMP) market is currently surging. However, many questions arise, what is food for special medical purposes? Where can patients access them? Is it classified as therapeutic goods? Who is the regulator of such products?

As per Standard 2.9.5 – Food for special medical purposes under Food Standards Australia New Zealand Act 1991 (Cth), FSMP means food that is:

  1. Specially formulated for the dietary management of individuals:
    1. By way of exclusive or partial feeding, who have special medically determined nutrient requirements or whose capacity is limited or impaired to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients in ordinary food; and
    2. Whose dietary management cannot be completely achieved without the use of the food; and
  2. Intended to be used under medical supervision; and
  3. Represented as being:
    1. A food for special medical purposes; or
    2. For the dietary management of a disease, disorder or medical condition.

In Short, FSMP may be used to help people suffering certain diseases, medical conditions or disorders and cannot meet the nutritional requirements via normal diet.

Even though they are food, consumers, cannot purchase them from local supermarkets. FSMP can only be provided via health care professionals, such as a medical practitioner or dietitian or pharmacists.

However, they are not considered therapeutic goods. The line between a medicine and therapeutic food has become even greyer over the past few years. TGA has developed an online tool – Food-Medicine Interface Guidance Tool – and encourages customers to familiarise themselves with the basics of food and medicine and regulation. Manufacturers and sponsors can also use the Tool to work out which regulatory regime would apply to their products.

Unlike therapeutic goods regulated by the TGA, FSMP are regulated by Food Standards Australia New Zealand (FSANZ), who developed the Food Standards Code. Standard 2.9.5 of the Food Standards Code regulates the composition, labelling and sale of food for special medical purposes. It limits FSMP to make any therapeutic claims, for example, FSMP cannot make a claim in relation to the prevention of the disease.

Because FSMP is so similar to a medicine, it may cause undesired effects as well. However, which regulatory authority should we report to? Under the mandatory reporting obligations section of the Australian Competition and Consumer Commission (ACCC) guidelines: “Individual suppliers are responsible for reporting incidents where consumer goods have been associated with a death or serious injury or illness of any person.” The manufacturers of the FSMP may wish to be conservative and report such cases to ACCC.

 

Our Medical Services team has extensive experience in Food for Special Medical Purposes. Call us on +613 9251 0777 to discuss how we can assist.

This article was written by Wenna Zhang, from our Medical Services team.




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Stressed? Well your products should be!

Forced Degradation Studies

Treating your drug substance or drug product with an acid, a base, an oxidising substance, heat or exposing it to direct light might sound extreme, but that is exactly what the TGA want to see in your registration dossier.

Assay results of around 100% are certainly ideal, but if your test method cannot distinguish the active ingredient from any impurities formed through degradation, then how can you be sure your product will remain safe and efficacious throughout its shelf life?

Forced degradation studies, also known as ‘stress testing’ studies, are used to demonstrate that the assay and impurity test methods are sensitive to the full range of potential degradation products that could form over the shelf-life of a drug product or drug substance. Regulatory authorities will expect to see this data in Module 3 of a registration dossier; however, it is important that the studies are performed correctly.

So how much stress?

Detailed instructions on how to perform stress testing are not readily available in published regulatory guidance documents. This is because there is no “one size fits all” when it comes to stress testing. What may be adequate for one product may be too extreme for another. Instead, stress testing studies should be designed considering the nature of the drug substance and drug product, along with some common sense.

Companies often apply conditions that are either too drastic, resulting in irrelevant degradation, or sometimes the conditions applied are not harsh enough and result in little or no significant degradation being observed. The ideal result under each of the five stress conditions (acid, base, oxidising, heat, light) is that the main compound is degraded by around 5-15% (ideally 10%). The conditions applied should also allow for some predictability of degradation pathways. Chromatographic conditions should ensure that degradants can be separated (as much as possible) and that they don’t interfere with measurement of the main compound or previously known impurities and degradants.

What about mass balance?

Another important measure of an acceptable stability-indicating test method is its ability to account for all the components produced under stressed conditions and over the ordinary shelf-life of the product. Ideally, the amount of decrease in the main active component has a directly corresponding increase in the amount of all the measured impurities and degradants. Where this is not the case, a few factors will need to be considered to ensure that mass balance can be achieved (or differences understood) such as improvements to the test method(s), changes to the stress conditions or possible degradation pathways which may hinder the detection or measurement of specific compounds.

Stress-testing is an important validation consideration and should be conducted very early in the development or implementation of new test methods rather than leaving it until regulatory authorities raise questions on the results.

 

Want to know more?

For assistance in reviewing or designing your forced degradation studies, please contact our expert Regulatory Services team on +61 3 9251 0777

This article was written by Tim Dow and Colleen Turnbull, from our Regulatory Services team




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Proposed updates to GVP Module VI and what this might mean for our clients

european-medicines-agency

Good pharmacovigilance practices (GVP) are a set of measures drawn up to facilitate the performance of pharmacovigilance in the European Union (EU). GVP apply to marketing-authorisation holders, the European Medicines Agency and medicines regulatory authorities in EU Member States. The TGA and Medsafe also occasionally refer to the GVPs in their regulations and guidance documents. It is important to keep abreast of any major changes to the GVPs, so that we are best able to help clients prepare for necessary changes.

The new draft of GVP Module VI (Management and reporting of adverse reactions to medicinal products) was released for public consultation in August 2016, with a deadline for comments mid October 2016.  Of interest are the following proposed changes: 

  1. Definition/terminology changes and additions – The definition of Occupational Exposure has been amended (clarification that it means only the medicinal product and not active ingredients/excipients during manufacture), the definitions of Medication Error and Falsified Medicinal Product have been added.  These updates or new definitions may be important for clients in terms of capturing good quality information. 
  2. Electrowinnic reporting modalities of ICSRs under the new ICH-E2B (R3) format (becomes compulsory in June 2017) – there have been many changes made to Module VI with regards to ICH-E2B (R3).  MAHs will need to understand these changes and be able to adopt them before the deadline.  Two important changes include:
    1. The addition of ‘Primary Source for Regulatory Purposes’ which covers multiple sources by identifying the source of the worldwide case number (enabling global pharma companies/clients with SDEAs to identify duplicate cases)
    2. The ability to capture information on the seriousness of multiple adverse reactions in a single ICSR for each individual reported adverse reaction
  3. ICSR reporting, and data quality management – The addition of a sub-section called Nullflavours (a collection of codes specifying why a valid value is not present in an ICSR, e.g. a value is applicable but is unknown such as age of patient).  The client will have to be familiar with these codes to produce valid reports.  A new section on amendment and nullification of reports (might be applicable following an internal audit, where a report is found to be erroneous or in need of correction, but no follow-up information is available. With regards to data quality management, the section which discusses correct data entry has been moved to the Quality Management section.  
  4. Validation of ICSRs based on patients and reporters’ identifiability – At least one patient identifier must be available to consider the case validated for reporting (e.g. initials, gender, age, identification number).  Also the HCP must now be characterised by their qualification AND at least one of the following parameters; name, address or phone number.  If these identifiers are not present, it will not be considered a valid report. This will be important for clients to ensure that all of their reports are valid. 
  5. Management of ICSRs described in the scientific literature – There are changes to literature monitoring requirements for MAHs.  Exclusion criteria for the reporting of ICSRs published in the scientific literature has been listed.  The EMA will be performing monitoring of medical literature and will make available a list of active substances and medical literature subject to this monitoring.  This will affect clients’ processes with regards to literature monitoring. 
  6. Collection of information on patients’ age – More emphasis has now been placed on the importance of obtaining the patient’s age/age group.  This is especially important for identifying issues in elderly or paediatric populations. Clients should be aware of this, so that collection of age can be attempted in initial case or follow-up.  
  7. Guidance on spontaneous reports (management of suspected adverse reactions (not related to any organized data collection systems and which are notified through medical enquiry/product information services or which are consequent of the distribution of information materials), management of reports from post-authorisation efficacy studies, cases notified by different reporters, referring to the same patient and same suspected adverse reaction, and at least one notification is done in an unsolicited manner) – this will be important for MAHs to enable them to correctly identify spontaneous reports.
  8. Transfer of the guidance on Emerging Safety Issues to another GVP Module (Module IX) 

The proposed draft can be found on the European Medicines Agency website.

 

Call our experienced Pharmacovigilance Team on +61 3 9251 0777 to discuss how these changes might affect you

This article was written by Beverley Worrall, from our Pharmacovigilance Team




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Medicine labels: TGO 91 and TGO 92. What’s the impact?

Medicine Labels

Following years of consultation and review the TGA has issued two new labelling orders to replace the current Therapeutic Good Order No. 69 for specific medicine labelling requirements:

  • Therapeutic Goods Order No. 91 – Standard for labels of prescription and related medicines (TGO 91)
  • Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92)
  • The creation of separate orders for prescription and non-prescription medicines was implemented to reflect how the products are used and ensure adequate information is available for the safe use of products.

    Some key changes introduced in the new TGOs will require that the labels for the majority of products supplied in Australia are revised. These include:

  • Increased prominence of the active ingredient with specified placement and size
  • Medicine name must be a cohesive unit without graphics of text
  • Additional warning statements and allergen declarations
  • For prescription medicines, addition of a dispensing label space
  • For non-prescription medicines, addition of a Critical Health Information table
  • Although the TGA has implemented a 4-year transition period before the new TGOs become mandatory, it is recommended that where new labels are being created, the new TGOs are adhered to now. This will avoid a rush to update labelling at the end of the period.

    For currently supplied products, the timing of labelling updates will need to be carefully managed over the transition period to ensure there is minimal write-off of packaging components and the appropriate variation applications are submitted (and approved) in a reasonable time period to ensure continued regulatory compliance.

     

    For assistance in updating or developing medicine labels that comply with the new orders, please contact our expert Regulatory Services team on +61 3 9251 0777.

    This article was written by Lynda Notting from our Regulatory Services team




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