Saturday 18 May 2013

Medical Affairs Role in Pharmaceutical Companies



The Medical affairs groups are a growing vital sector in today's bio pharmaceutical industry in providing hospital consultants, key opinion leaders (KOL's), regulatory agencies and healthcare professionals with scientific and medical information relating to the value and correct usage of the products. 

Medical affairs personnel strive for the highest scientific integrity so as to produce successful clinical trials and supply the greatest support for the market. Medical affairs groups perform many activities often overlapping with sales, Medical marketing, clinical growth, and customer service. 

Sales groups may be ill-positioned to accurately present the new product to physicians and quite often need help in making more expert presentations. Medical affairs groups might help in developing appropriate positioning for new releases and help to leveraging the newer indications to come.
Pharmaceutical companies spend tremendous resources for development of new drug treatments. A great deal of time is spent in doing research on potential health-related products and medicines.
While considering the distinctions between post marketing scientific tests and clinical registration demos, medical affairs can fill the requirement for the studies done post approval.

Medical Affairs Role in Functional Areas:
Medical Affairs acts as the central focal point for different therapeutic areas of sales, marketing and research. Medical Affairs work closely with various functional departments such as:

Medical Writing

Scientific Development and Reviewing connected with Product profiles, monographs, package deal insert/ patient information booklet, pharmacology and toxicology parts of registration dossiers with constant updates.


Preparation of Professional medical Development Plan
Providing therapeutic and scientific content for development of study standard protocol
Designing and implementation connected with pharmacoeconomic studies

Reviewing along with approval of regulatory submission, manuscripts, abstracts, posters as well as other scientific documents.

Medical Monitoring:
Medical affairs are the Primary medical contact towards the sponsor, investigative website, and project group.
Medical Affairs supports the look, conduct and evaluation of clinical research and involves continuous data maintenance as well as management.
Involves in talk on study feasibility together with Key Opinion Leaders as well as other potential investigators with regards to possible logistical requirements of the study protocol as well as responds to subject eligibility and disengagement questions.
A Medical affairs team is usually responsible for Medical Monitoring:
Medical affairs are the Primary medical contact towards the sponsor, investigative website, and project group.
Medical Affairs supports the look, conduct and evaluation of clinical research and involves continuous data maintenance as well as management.
Involves in talk on study feasibility together with Key Opinion Leaders as well as other potential investigators with regards to possible logistical requirements of the study protocol as well as responds to subject eligibility and disengagement questions.
A Medical affairs team is usually responsible for clinical trials Protocol and study linked training for researchers and site personnel.


During Pre launch cycle of drug the actual Medical Affairs team will establish a KOL strategy for this product based upon prescriber's interest in research and education for your given indication. Then MA departments will target prospective KOLs and connect to them regarding the actual science behind the revolutionary product, ongoing trials like the balanced information regarding both positive along with negative results. Also discuss the important thing data from healthcare meetings and summaries of changes to apply the guidelines. In addition it will conduct additional education activities of Sales/Marketing individuals to raise awareness of the disease state, current therapeutics, and current gaps in sufferer care. Further, the interests of the KOLs will be assessed during discussions to find out the appropriate scientific exchange and any prospective opportunities for potential investigator-initiated trials (IITs).
At the time of product launch MA was responsible in ensuring clear understanding on utilization of the product by the prescribers. They exchange technological information regarding compound-specific characteristics and physician perceptions of the drug profile. In those times MA will perform an evaluation of IIT proposals that might generate a Step IV strategy which will further differentiate the merchandise post-marketing.

During the Post-launch period of a drug, MA seeks suggestions from KOLs and along with this, it resolves the queries regarding the product ensuring that they know exactly how you can use the product or service. MA maintains the collection of information regarding the acceptance of the product among prescribers along with issues being confronted by the drug. These valuable data will update marketing work as deemed necessary. Further discussions upon clinical practice roles and potential extra indications with KOL's facilitate the commencement regarding IITs and Step IV studies.

Conclusion:

Medical Affairs is the majority of credible link with external stakeholders and also play a progressively more important role in communicating the product or service value message to physicians in an objective and ethical manner. They provide assistance in dissemination of technological information regarding current products to regulating agencies and healthcare professionals. Thus Medical Affairs play an important role in establishing appropriate positioning for new items and help to  help leverage the newer indications in the future.

Read more…

Thursday 25 April 2013

ESSENTIALS OF MEDICAL WRITING

Professional medical writing involves communication of clinical and scientific data in the form of research and regulatory paperwork, articles for publication, in addition to content development for health-related publications, pharmaceutical companies and professional medical websites. The nature of medical writing varies using the need of the end user; for example documents regarding medical journals, physicians, individuals, pharmaceutical companies etc.

A capable Medical Writer must have good understanding of life science, medical and pharmaceutical terms along with proper knowledge of The english language. Qualities of a simple yet effective Medical Writer comprise of correct interpretation of target audience needs, better perception of project objectives, ability to prepare thoughts and deliver inside stringent timelines.

Medical writing gets started with appropriate literature seek and identification of reliable cause of information. In order to develop and frame an original work it truly is obligatory to apprehend the topic well by thorough literature review. Moreover, fact presentation in any scientific article is justified judging by genuine references, which makes literature search much more important.
Literature search ends up by having an unorganized pile of raw material which should be shaped and constructed in a order. There must be cohesion among sentences those must grow and count on each other, thus building logically correlated paragraphs. Such glued paragraphs are designed for conveying the medical author ideas effectively, whereas any non-cohesive mass of sentences leaves the reader mixed up and frustrated. The principle of cohesion with medical writing is that the sentences must provide linear move of information making file appealing and interesting for you to reader.

A careful selection in addition to elimination of data in addition to information from collected material is essential. A good medical writer should not stray from the subject. Content must be educational, well-constructed and correlated to hold the reader curious all through. A skillful assemblage of facts is necessary to guide the reader over the write up from what he knows as to the he wants to know in accordance to his needs in addition to expectations.

Medical Writer must allow you to assembling the draft inside a proper format, with apparent and precise explanation shown without ambiguity. Once a draft is prepared it truly is revised repeatedly to make it more comprehensible, communicative in addition to revealing. Medical writer should be capable of comprehend the prerequisites of varied types of articles one example is research article, original post, systematic review, brief record, editorial, case reports, in addition to letter to editor. Along with manuscript preparation, an effective Medical Writer should develop the skills to ascertain the high quality (based upon factors like impact factor and different indexes or rankings) and choice of journals. A clear check out of journal specific requirements is equally important. On top of that, medical writing includes prep of write ups regarding conferences; promotional items for marketing and sales team and training material.

Other attributes of your competent Medical Writer include presentation in the data in accordance for you to client’s requirement or predefined SOPs and most crucial of all is usually to avert plagiarism.
There is a significant need for efficient Medical Writers in drug companies, biotech organizations, nursing homes, contract research organizations (CROs) as well as other health communication agencies. The particular ever changing world of clinical and scientific study demands continuous propagation of technical knowledge. Medical writing is a compelling demand of contemporary scientific world.

WorkSure™  provides a wide range of high quality Medical Writing Services for pharmaceutical,  biotech and medical devices companies. Our team of qualified and experienced medical writers helps you bring out a wide range of regulatory, clinical, scientific and marketing communication documents allowing you to focus on your core competency areas.

Read more…

Tuesday 19 March 2013

Medical marketing shall avoid misleading advertisements and disease mongering

Medico advertising and marketing consists of campaign associated with pharmaceutical drug products. It allows for for you to consistently bring up to date medical professionals, the medical staff in addition to pharmacists concerning the safe and effective utilization of medicines. Medical marketing involves routines by simply medicos or even organizations for you to actualize areas regarding pharmaceutical drug treatment.

The entire world Health Organization defines pharmaceutical drug campaign because “all information in addition to influential routines performed by simply pharmaceutical drug makers in addition to suppliers, attempting to have an impact on your health professional prescribed, offer, purchase, and/or utilization of professional medical drugs”.

The actual achievement associated with medico advertising and marketing depends upon your approaches or even strategies adopted regarding advertising and marketing. A powerful advertising and marketing operations depends upon method associated with objectives, identification of any market you work in, possessing a plan to own objective in addition to evaluation associated with marketing strategy at standard time periods regarding examining your improvement.

Pharmaceutic firms utilize a pair of water ways associated with advertising and marketing tactics: 1) push flow in addition to 2) pull flow. Thrust flow technique goals for you to influence conclusion maker’s (physician’s) health professional prescribed habits through marketing such things as detailing, substance sample, record content articles, record marketing, management meetings, professional medical meetings and so forth. Yank flow technique is usually precise on end people in addition to pressurizes medical professionals for you to suggest a certain substance according to patient’s obtain.

Advertisements are crucial regarding examining home elevators medicines for you to medical professionals and are also trusted by simply pharmaceutical drug firms regarding campaign of their products. Info offered with adverts needs to be associated with premium quality in addition to must not be incorrect or even do not forget that. Advertisements which in turn exaggerate the benefits of medicines in addition to usually participate in decrease possibility linked to drug treatments, can result in possible unwanted side effects. Health professionals pursuing this sort of marketing information may jeopardize existence on the affected individuals by simply recommending unreasonable drug treatments. Therefore, pharmaceutical drug firms should steer clear of unethical medico advertising and marketing practices including mistaken adverts in addition to illness mongering.

The actual medico advertising and marketing office associated with almost any pharmaceutical drug organization should stick to 3 main limitations:
1)    The worldwide Federation associated with Pharmaceutic Manufacturers (iFPMA) rule associated with pharmaceutical drug advertising and marketing practices
2)    The globe Health Organization’s honourable requirements regarding therapeutic substance campaign
3)    The rule served by Health Action Worldwide

WorkSureTM concentrates on Medico-marketing in addition to Health-related Extramarital liasons Managing in addition to assist business to honourable merchandise campaign.

Read more…

Tuesday 5 March 2013

Investigational Medicinal Product Dossier



Clinical Trial Authorization (CTA) is compulsory to conduct medical tests in people. CTA can only be acquired after submission of a number of medical records in the type of Investigational Medicinal Products Dossier (IMPD). EU Medical Tests Instruction 2001/20/EC describes “Investigational medicinal product” (IMP) as, “A medication way of an effective material or sugar pill being examined or used as a referrals in a medical trial, such as products already with a promotion authorization but used or constructed (formulated or packaged) in a way different from the approved type, or when used for an illegal sign, or when used to obtain further details about the approved type. IMPD is ready for obtaining CTA for an IMP and its use in the medical trial, such as details about referrals products and placebos. Apart from this, information from nonclinical research and past facts of medical use of IMP is required in IMPD and if such detail is missing, justification for the same should be offered in the program. IMPD can be of two types: a complete IMPD and a simple IMPD.
A complete IMPD is needed if no before distribution of any details about the substance or medical item is created to the qualified power and in situations when information cannot be mix known. A complete IMPD should integrate summaries of details regarding excellent, produce and management of the IMP along with non-clinical and medical information such as creature pharmacology and toxicology research, previous reports of medical trial and individual experiences with the item, overall danger and advantage evaluation. Usually, the dossier should not be huge papers, even though exclusions may happen. Data should be offered in tabular type along with brief information featuring everything.
A simple IMPD is sufficient if all necessary details relevant to the IMP had been formerly analyzed as aspect of a promotion authorization in any nation or as part of Clinical Trial Authorization (CTA) to the concerned Competent Authority. The material must contain a conversation about the danger and advantages of suggested trial. Summary of item features (SmPC) maybe used as IMPD in situations where IMP has a Marketing Permission in any EU Participant Condition and is being used in the same type, for the same sign and with a dosing routine protected by the SmPC.
As per “Checklist for programs for allow of acceptance of various groups of New Drug, International Medical trial and Bioequivalence research for trade purpose” by CDSCO (Central Medication Conventional Control Organization), the IMPD is essential for “Application of International Medical Trial” in Indian.

Read more…

Friday 25 January 2013

Clinical Trial Application (CTA) submission in India


A Clinical Trial Application (CTA) is submitted to regulatory authority (Drugs Controller General of India) to seek approval for conduct of a clinical trial in India. Form 44 is an application made for grant of permission to import or manufacture a new drug or to undertake Clinical Trial. The trial sponsor has to submit the application (Form 44) and documents pertaining to chemical and pharmaceutical information, animal pharmacology, toxicology data and clinical pharmacology data.  Other trial-related documents that must be submitted for approval include the Investigator’s Brochure, trial protocol, case report form, informed consent form, patient information sheet, investigator’s undertaking and IEC approvals (if obtained  during review process). Regulatory status of the trial in other participating countries also needs to be reported. Additional requirements exist for studies in special populations, e.g., children, pregnant women, nursing women, elderly patients, patients with renal or other organ system failure, and those on specific concomitant medication(s).

Submission of clinical trial applications have been classified into two categories: A and B since 1st December 2006. Category A trial submission comprises of protocols which have been approved by EMEA or regulatory authorities in US, UK, Japan, Australia, Canada, Germany, Switzerland or South Africa. The projected timelines for approval of Category A application is around two to four weeks. Category B trial submission undergoes the standard review process by expert committee and the turnaround time for approval is about eight to twelve weeks. An impediment in approval timelines occur in case of incomplete applications or due to delay in resolution of queries by the sponsor.  If a submission is made under category B and later approvals are sought from a Category A country still the submission category cannot be modified. Review period may also get prolonged if Drugs Controller General of India (DCGI) requests assistance from Indian Council for Medical Research (ICMR) or Department of Biotechnology (DBT) based on the application.

We at WorkSure™ support in preparation of Clinical Trial Application and related documents viz. Investigator’s Brochure, trial protocol, case report form, informed consent form, patient information sheet, EC submission document etc. WorkSure also provides technical expert representation to undertake discussions with regulatory authority.

Read more…