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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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    Patient support program – the key driver of better health outcomes

    patient support program

    Pharmaceutical companies play a key role in supporting the quality use of medicines through patient focused programs. These programs are designed to aid compliance and lifestyle choices. They provide significant value to patients through the accessibility of information and support.

    Each program run by a pharmaceutical company is managed under strict ethical guidelines and for a specific medicine. Participation is only available to patients who have already been prescribed a medicine and supported by their healthcare professional.

    Programs can provide information to patients about their condition, how to better manage their health, or encourage adherence to the medicines they have been prescribed. They are aimed to complement the important roles their doctors and pharmacists play in the management of their condition.

    Companies must ensure that all aspects of a program including written materials or verbal interactions are patient focused and are not in any way promotional nor have the intention of promoting a prescription medicine to members of the general public.

    A rationale must be developed for each program which describes the clinical significance of the program, the anticipated number of patients to be enrolled, the type of educational/informational material to be provided to a patient, the number of interactions (if any) that may be had with a patient and the duration of the program. Any communication with a patient considering enrolling in a patient support program should clearly identify the company, what materials or calls the patient may receive and their rights under the program. Companies have a duty of care to ensure that patients are fully aware how their privacy and confidentially is maintained and that they can elect to opt out of a program at any time. Patients should also be advised how and who will be holding their data and assurances given that data will not be used for purposes other than for the designed program. At specified intervals companies should evaluate whether a program is delivering on its initial objectives including improvements in compliance and patient wellbeing.

    The importance of reporting adverse events identified through interactions with patients enrolled in patient support programs cannot be over emphasised. Careful monitoring of programs ensures accurate and timely reporting of de-identified product safety related information. It also aids our understanding of medicines in the post market environment.

    Medicines Australia Code of Conduct has detailed provisions on how such programs should be administered and recognises that they offer important support to patients and have a key role to play in delivering positive health outcomes.

     

    Our Medical Services team has extensive experience in patient focused programs. Call us on +613 9251 0777 to discuss how we can assist.

    This article was written by Terence Khoo, from our Medical Services team.




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    Commercial Eyes Recruiting: Regulatory Services Manager

    Regulatory Services Manager

    Commercial Eyes has a great opportunity for a Regulatory Services Manager

    Reporting to the Director, Regulatory Services, the Manager is responsible for the day to day operational management of the regulatory team and the assigned project portfolio within the Regulatory Services business unit.

     

    To be successful in this role, you will have…

    • A degree in science, pharmacy or a related discipline.
    • A minimum of 10 years of experience in Australian and New Zealand regulatory affairs, preferably in a commercial environment.
    • Ability to develop sound strategies to resolve complex regulatory problems.
    • Good working relationships with relevant TGA staff and experience with TGA pre-submission meetings.
    • Experience in the review, critical evaluation and presentation of clinical data.
    • Good knowledge of TGA legislation, regulations, guidelines and working procedures.
    • High level written and oral communication skills.
    • Proven ability to manage projects.
    • Experience or aptitude for mentoring and leadership
    • Experience in staff management in a regulatory environment.
    • Ability to deal with high level of confidentiality.

     

    Key responsibilities include:

    • Manage regulatory projects and staff to ensure optimum project outcomes.
    • Ensure agreed financial and organisational targets are met.
    • Undertake key account management and day-to-day liaison with clients as agreed with the Director, Regulatory Services.
    • Undertake business development and assist the Director, Regulatory Services to develop business development and other growth strategies.
    • External Representation of the business unit where possible
    • Attract new talented regulatory professionals to join the business.
    • To provide support to clients on the registration and listing of pharmaceuticals and medical devices in Australia and New Zealand.
    • Provide strategic advice to clients regarding the Australian and New Zealand regulatory environment.

     

    In return….

    This role is a rewarding one that will offer a competitive salary to the right candidate and a rare opportunity to lead a dynamic and successful team. You will also have access to a flexible work environment, life-work balance and the opportunity to expand your professional network working with local and multinational pharmaceutical companies, as well as a range of other companies developing novel and cutting edge health technologies. 

    Becoming part of the CEPL team will also provide you with a strong sense of teamwork, job satisfaction and achievement whilst working in a well-known professional services organisation that recognises talent and expertise as one of its biggest assets. 

     

    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: Senior Market Access Consultant

    Market Insight Manager

    Commercial Eyes has a great opportunity for a Senior Market Access consultant

    to join our dynamic Market Access team. Reporting to the Health Economics and Market Access Manager, this senior consulting role offers the successful candidate the opportunity to gain valuable market access experience across a wide variety of projects for the pharmaceutical, medical device and wider health care industry.

     

    To be successful in this role, you will have…

    • Minimum undergraduate qualifications in economics or a life sciences discipline.
    • Preferably post graduate qualifications in health economics, statistics, or health sciences.
    • Minimum 6 years commercial life sciences experience.
    • Excellent numerical, verbal reasoning and written communication skills.
    • Excellent problem solving and project management skills.
    • Proficiency in building productive relationships and networks.
    • A keen interest in the practice of consulting.

     

    Key responsibilities include:

    • Providing high quality expert consulting services to clients, in the key areas of reimbursement strategy, health economics, statistics, submission development and private/public market pricing.
    • Working with existing and potential clients in the life sciences sector to understand their business needs and identify areas or activities with which CEPL may be able to assist.
    • Translating these conceptual discussions into concrete project proposals which provide a realistic description of the scope of work to be undertaken and a competitive cost estimate for this.
    • Delivery of strategically and technically sound submissions, reports and presentations according to agreed deadlines and client requirements.
    • Building strong interpersonal networks across the life sciences sector and drawing on these to identify potential short and long term business opportunities for CEPL.
    • Working with the Manager and other stakeholders to identify important skills and knowledge gaps in the current CEPL reimbursement and pricing service offering; and to implement solutions to these service gaps; e.g. mentoring and developing junior consulting staff, negotiating access to key information sources, and identifying/working with new/existing partner organisations.

     

    In return….

    This role is a rewarding one that will offer a competitive salary to the right candidate. You will also have access to a flexible work environment, life-work balance and the opportunity to expand your professional network working with local and multinational pharmaceutical companies, as well as a range of other companies developing novel and cutting edge health technologies. 

    Becoming part of the CEPL team will also provide you with a strong sense of teamwork, job satisfaction and achievement whilst working in a well-known professional services organisation that recognises talent and expertise as one of its biggest assets.

     

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




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